<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03277144</url>
  </required_header>
  <id_info>
    <org_study_id>DRTST.01</org_study_id>
    <nct_id>NCT03277144</nct_id>
  </id_info>
  <brief_title>Incidence of Duodenal Stump Fistula After Gastrectomy for Gastric Cancer. A Randomized Controlled Trial</brief_title>
  <acronym>DRTST</acronym>
  <official_title>Does the Technique of Duodenal Resection Affect the Incidence of Duodenal Stump Fistula After Gastrectomy for Gastric Cancer ? A Randomized Controlled Trial (DRTST: Duodenal Resection Tri-staple Technology)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Turin, Italy</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Turin, Italy</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The goal of this trial is to demonstrate that the use of Tri-Staple Technology for duodenal&#xD;
      resection during open gastrectomy for cancer is safer than the use of other conventional&#xD;
      methods of resection/closure of the duodenum and that the incidence of duodenal fistula can&#xD;
      be decreased to that observed after the use of this technology in Laparoscopic and robotic&#xD;
      gastrectomy, therefore almost three times lower than that currently reported in literature.&#xD;
&#xD;
      Participating centres must have an annual volume of at least 20 gastrectomies per year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      BACKGROUND Gastric cancer is still one of the most frequent malignancies in Europe. In United&#xD;
      States the estimated new cases in 2010 were 21000 (12730 male and 8270 female) with 10570&#xD;
      estimated deaths (6350 male and 4220 female)[7,8]. In Italy the estimated new cases in 2013&#xD;
      were 13200 (7900 males and 5300 female) (AIOM-AIRTUM, I numeri del cancro in Italia - 2013,&#xD;
      www.registri-tumori.it) .The incidence rates in 2005-2009 were 21.6 and 10.8 per 100,000 in&#xD;
      males and females respectively. The mortality rates in 2005-2009 were 14.9 and 7.3 per&#xD;
      100,000 in males and females respectively. (www.itacan.ispo.toscana.it).A total or subtotal&#xD;
      gastrectomy with D2 lymph node dissection and R0 margins remains the standard of care for&#xD;
      gastric cancer[9,10]. Despite this, in low-volume centers gastrectomy still remains a&#xD;
      challenging procedure with a notable morbidity rate (33%-43%) and mortality rate&#xD;
      (7%-12%)[11,12]. Duodenal stump fistula (DSF) represents an infrequent but severe&#xD;
      complication after total or subtotal gastrectomy for gastric cancer, with incidence of 2,5 -&#xD;
      5% and mortality rate ranging from 7% to 67%(1-5). Several factors were identified as&#xD;
      possible cause of DSF, such as local hematoma, inflammation, intra-operative inadequate&#xD;
      closure of the duodenal stump, incorrect drain position, devascularization, post-operative&#xD;
      distension of the duodenum and R1-R2 resections[2,13].&#xD;
&#xD;
      There are many DSF-related complications leading to longer hospitalization times, such as&#xD;
      intra-abdominal abscesses, wound infections, diffuse peritonitis, sepsis, malnutrition,&#xD;
      pancreatitis, abdominal bleeding, and pneumonia. (3) DSF is often difficult to treat because&#xD;
      of the highly enzyme-rich duodenal juice and deep location of the fistula. In a retrospective&#xD;
      multicenter study (2) 3,685 patients undergoing gastrectomy for malignancies who developed 68&#xD;
      DSFs were analyzed; it was reported that DSF features had changed in the last 30 years and&#xD;
      that DSF alone no longer leads to death; some complications observed in the past, such as&#xD;
      fluid and electrolyte loss and dermatitis, have disappeared owing to improvements( in&#xD;
      particular parenteral nutrition and wound care). However, additional new complications such&#xD;
      as bleeding and fistulas of neighboring organs were emerging. Although medical therapy is&#xD;
      associated with better outcomes, surgery is still mandatory in cases of severe abdominal&#xD;
      sepsis or bleeding not otherwise manageable.&#xD;
&#xD;
      However, reoperation is often ineffective owing to postoperative edema and inflammation, and&#xD;
      the prognosis of patients undergoing surgery for DSF remains very poor. To improve the&#xD;
      outcome of these patients, many surgical procedures have been proposed from washing the&#xD;
      peritoneal cavity and abdominal drainage to tube duodenostomy (14,15), closure of the&#xD;
      fistula, fistula repair with a rectus abdominis flap (16), fistula closure by Roux-en-Y&#xD;
      duodenojejunostomy(17,18), biliogastric diversion, laparostomy, and pancreatoduodenectomy&#xD;
      (19) but surgeons are often unsure about the best management and the result are often&#xD;
      unsuccessful.&#xD;
&#xD;
      In a recent Korean national RCT (6) on open (ODG) vs laparoscopic distal gastrectomy (LADG),&#xD;
      the incidence of duodenal stump leakage after laparoscopyc gastrectomy was about 1%; in this&#xD;
      population study the use of tri-staple technology for duodenal resection was mandatory. In&#xD;
      our clinical practice, the incidence of DSF after open gastrectomy is about 3-5% adopting&#xD;
      different techniques of duodenal stump resection/closure.&#xD;
&#xD;
      The aim of this study is to evaluate if duodenal stump resection/closure using tri-staple&#xD;
      technology can significantly decrease the incidence of DSF after open gastrectomy as compared&#xD;
      to the other conventional methods adopted in the clinical practice (1% vs 5%).&#xD;
&#xD;
      We have designed a national multicentre pragmatic (20) RCT to compare the use of endoGIA or&#xD;
      Echelon (triStaple technology) to other conventional methods (GIA with or without manual&#xD;
      reinforcement , manual suture, purse string) for duodenal resection/closure during open&#xD;
      gastrectomy, with the assumption that Tri-staple technology without reinforcement ( as&#xD;
      routinely used in LADG) is the safest method.&#xD;
&#xD;
      AIM OF THE STUDY The goal of this trial is to demonstrate that the use of Tri-Staple&#xD;
      Technology for duodenal resection during open gastrectomy for cancer is safer than the use of&#xD;
      other conventional methods of resection/closure of the duodenum and that the incidence of&#xD;
      duodenal fistula can be decreased to that observed after the use of this technology in&#xD;
      Laparoscopic and robotic gastrectomy, therefore almost three times lower than that currently&#xD;
      reported in literature.&#xD;
&#xD;
      Participating centres must have an annual volume of at least 20 gastrectomies per year.&#xD;
&#xD;
      Design of the study This is a multicentre randomized controlled trial.&#xD;
&#xD;
      Patients with malignant tumor of the stomach, as primary diagnosis, requiring distal or total&#xD;
      gastrectomy without anastomosis with the duodenum will undergo clinical preoperative workout&#xD;
      and anaesthesiologist evaluation. All patients who meet the inclusion/exclusion criteria and&#xD;
      agree to sign the informed consent are registered into the trial and randomized to one of the&#xD;
      two arms (a. Duodenal Stump Closure with TriStaple Technology - TST or b. Duodenal Stump&#xD;
      closure with other conventional techniques - OCT ) as described in the chapter Randomization.&#xD;
      In TST arm no manual reinforce of the mechanical suture should be perfomed; in OCT group, a&#xD;
      manual reinforce of the suture can be done according to the preference of the operator, and&#xD;
      recorded in the trial data base (DB).&#xD;
&#xD;
      Patients' postoperative course will be carefully monitored and all variables detailed below&#xD;
      will be recorded in the DB.&#xD;
&#xD;
      DSF will be diagnosed by the presence of duodenal fluid in the surgical drainage and&#xD;
      confirmed by a CT scan when needed (presence of intra-abdominal peri-duodenal collection of&#xD;
      fluid and/or micro air bubbles).&#xD;
&#xD;
      Also the type of treatment (conservative, percutaneous drainage, reoperation, others ) of DSF&#xD;
      should be recorded, as well as the length of hospital stay and other postoperative&#xD;
      complications or in-hospital death ( as well as 30- and 90- days mortality)&#xD;
&#xD;
      Trial setting&#xD;
&#xD;
      This is an Italian national multicentre RCT; the Division of General Surgery from University&#xD;
      of Turin, Department of Surgical Sciences, AOU San Luigi Gonzaga di Orbassano, will be the&#xD;
      Coordinating Centre of the trial. The P.I. of the trial is Prof Maurizio Degiuli.&#xD;
&#xD;
      S.S.D. Epidemiologia, Clinica e Valutativa, AOU Città della Salute e della Scienza di Torino,&#xD;
      will be responsible for this trial's central randomisation and statistical analysis.&#xD;
&#xD;
      Clinical monitoring and data managing will be performed by the P.I. and and co-investigators.&#xD;
&#xD;
      Study population&#xD;
&#xD;
      inclusion criteria&#xD;
&#xD;
      pathologically proven malign tumor of the stomach age of 18 to 80 years, no history of other&#xD;
      cancers no history of radiotherapy in supra-mesocolic space total or distal gastrectomy&#xD;
      without anastomosis with the duodenum&#xD;
&#xD;
      exclusion criteria&#xD;
&#xD;
      emergency surgery American Society of Anesthesiologists class &gt; 3 need for combined resection&#xD;
      of other organs laparoscopic/robotic access severe heart disease liver cirrhosis T stage&#xD;
      &gt;cT4a citology positive at preoperative laparoscopy cM+ cD+&#xD;
&#xD;
      All patients freely give informed consent to participate in the study prior to surgery, at&#xD;
      the time of discussing the intervention with the surgeon or the nurse and can decide to&#xD;
      withdraw from the study at any time.&#xD;
&#xD;
      Diagnosis of DSF&#xD;
&#xD;
      A diagnosis of DF is made on the basis of the presence of duodenal juice in the surgical&#xD;
      drainage or its leakage through the abdominal wall, and confirmed by CT scan and/or&#xD;
      fistulography.&#xD;
&#xD;
      Variables&#xD;
&#xD;
      sex age ASA score COPD type 2 DM multiple comorbidities pre-operative albumin serum levels&#xD;
      pre-operative lymphocytes blood count cT Stage / pTStage pTNM distal margin involvement&#xD;
      intraoperative blood loss lenght of hospital stay Type of gastrectomy TG vs DG type of&#xD;
      reconstruction: ( BII vs RY) lymph node dissection: D1, D1+, D2, &gt; D2&#xD;
&#xD;
      Type of duodenal stump closure device:&#xD;
&#xD;
      A. endoGIA tristaple B. other techniques (GIA/TA with or without manual reinforcement (simple&#xD;
      interrupted suture or running suture), manual suture (simple interrupted or running suture),&#xD;
      purse string)&#xD;
&#xD;
      Development of DSF (po day) healing of DSF (po day) Diagnosis of DSF Daily output of DSF Type&#xD;
      of treatment of DSF Other postoperative morbidity according to Dindo. Postoperative mortality&#xD;
&#xD;
      Randomisation&#xD;
&#xD;
      All patients who meet the inclusion/exclusion criteria and give the informed consent to&#xD;
      participate are registered into the central trial database and centrally randomized to one of&#xD;
      the two groups (a. Duodenal Stump Closure with TriStaple Technology - TST or b. Duodenal&#xD;
      Stump closure with other conventional techniques - OCT ).&#xD;
&#xD;
      Patients refusing recruitment are treated with usual care and contribute to the database a&#xD;
      limited set of pre-defined information.&#xD;
&#xD;
      Result of randomisation is communicated to the surgical team at the time of their entrance in&#xD;
      the surgical theatre.&#xD;
&#xD;
      Sample size calculation and statistical analysis&#xD;
&#xD;
      Assuming an alpha error at the 5% level and power 80%, a total of 700 patients (350 per arm)&#xD;
      are required in order to recognise a true difference of 5% in (a) vs 1% in (b).&#xD;
&#xD;
      Assuming an average case volume of 20 patients per year and 60% acceptance rate, about 30&#xD;
      Centres recruiting for two years will need to be involved.&#xD;
&#xD;
      Cox regression with multivariable analysis will be performed&#xD;
&#xD;
      Data property&#xD;
&#xD;
      Results will be the property of Università degli studi di Torino and of the researchers&#xD;
      involved in the conduction of the mulicentre project. A scientific committee will be&#xD;
      constituted comprising a lead investigator from each of the Centres.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">September 11, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>All gastric cancer patients who meet the inclusion/exclusion criteria and give the informed consent to participate are registered into the central trial database and centrally permuted-block randomized to one of the two arms (a. Duodenal Stump Closure with TriStaple Technology - TST or b. Duodenal Stump closure with other conventional techniques - OCT ).</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of duodenal stump leak</measure>
    <time_frame>within 30/60 days from operation</time_frame>
    <description>The aim of this study is to evaluate if duodenal stump closure using tri-staple technology can significantly decrease the incidence of duodenal stump leakage to 1% as compared to other conventional methods (5%). So the primary endpoint is :&#xD;
- incidence of DSF, diagnosed on the basis of the presence of duodenal juice in the surgical drainage or its leakage through the abdominal wall, and confirmed by CT scan and/or fistulography.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>cost of surgery</measure>
    <time_frame>within 90 days from operation</time_frame>
    <description>cost of devices, hospital stay, drugs, examinations</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>operative time for duodenal stump closure</measure>
    <time_frame>intraopeartively</time_frame>
    <description>time ( min) necessary for duodenal stump closure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>short-term postoperative complications</measure>
    <time_frame>within 30 days from operation</time_frame>
    <description>onset of postoperative complications according to Clavien-Dindo classification</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>blood loss</measure>
    <time_frame>intraopeartively</time_frame>
    <description>intraoperative blood loss (ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>lenght of hospitalization</measure>
    <time_frame>120 days after operation</time_frame>
    <description>duration (days) of hospital stay after operation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Operative mortality</measure>
    <time_frame>30 and 60 days after operation</time_frame>
    <description>post-operative death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of DSF by surgical volume</measure>
    <time_frame>one year</time_frame>
    <description>rate of duodenal stump leak of every participating center</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">700</enrollment>
  <condition>Gastric Cancer</condition>
  <condition>Duodenal Stump Leak</condition>
  <arm_group>
    <arm_group_label>TST-TriStaple(3lines stapler)Technology</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>During gastrectomy for gatric cancer without anastomosis with the duodenum, Duodenal Stump is closed with a TriStaple (three-lines linear stapler) Technology device.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>OCT (other conventional techniques)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>During gastrectomy for gatric cancer without anastomosis with the duodenum, Duodenal Stump is closed with conventional techniques including manual sutures and devices with only two lines of staples.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>TST-TriStaple(3lines stapler)Technology</intervention_name>
    <description>Duodenal stump closed using a Tristaple ( three-lines linear stapler) device</description>
    <arm_group_label>TST-TriStaple(3lines stapler)Technology</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>other conventional techniques</intervention_name>
    <description>Duodenal stump closed using other conventional techniques entailing manual suture or mechanical devices with only two lines of sutures.</description>
    <arm_group_label>OCT (other conventional techniques)</arm_group_label>
    <other_name>double-line linear stapler with manual reinforcement</other_name>
    <other_name>manual suture</other_name>
    <other_name>purse string suture</other_name>
    <other_name>double-line linear stapler without manual reinforcement</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pathologically proven malign tumor of the stomach&#xD;
&#xD;
          -  age of 18 to 80 years,&#xD;
&#xD;
          -  no history of other cancers&#xD;
&#xD;
          -  no history of radiotherapy in supra-mesocolic space&#xD;
&#xD;
          -  total or distal gastrectomy without anastomosis with the duodenum&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  emergency surgery&#xD;
&#xD;
          -  American Society of Anesthesiologists class &gt; 3&#xD;
&#xD;
          -  need for combined resection of other organs&#xD;
&#xD;
          -  laparoscopic/robotic access&#xD;
&#xD;
          -  severe heart disease&#xD;
&#xD;
          -  liver cirrhosis&#xD;
&#xD;
          -  T stage &gt;cT4a&#xD;
&#xD;
          -  citology positive at preoperative laparoscopy&#xD;
&#xD;
          -  cM+ (clinical suspicion of distant metastasis)&#xD;
&#xD;
          -  cD+ (clinical suspicion of duodenal involvment)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maurizio Degiuli, MD Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Turin, San Luigi University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rossella Reddavid, MD</last_name>
    <phone>+393479848651</phone>
    <email>rossella.reddavid@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Andrea Evangelista</last_name>
    <phone>+390116336855</phone>
    <email>andre.evangelist@cpo.it</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>San Luigi University Hospital</name>
      <address>
        <city>Orbassano</city>
        <state>Turin</state>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Maurizio Degiuli, Professor</last_name>
      <phone>+390119026525</phone>
      <email>maurizio.degiuli@unito.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Inghelmann R, Grande E, Francisci S, Verdecchia A, Micheli A, Baili P, Capocaccia R, De Angelis R. Regional estimates of stomach cancer burden in Italy. Tumori. 2007 Jul-Aug;93(4):367-73. doi: 10.1177/030089160709300407.</citation>
    <PMID>17899867</PMID>
  </reference>
  <reference>
    <citation>Aurello P, Bellagamba R, Rossi Del Monte S, D'Angelo F, Nigri G, Cicchini C, Ravaioli M, Ramacciato G. Apoptosis and microvessel density in gastric cancer: correlation with tumor stage and prognosis. Am Surg. 2009 Dec;75(12):1183-8.</citation>
    <PMID>19999909</PMID>
  </reference>
  <reference>
    <citation>Aurello P, Magistri P, Nigri G, Petrucciani N, Novi L, Antolino L, D'Angelo F, Ramacciato G. Surgical management of microscopic positive resection margin after gastrectomy for gastric cancer: a systematic review of gastric R1 management. Anticancer Res. 2014 Nov;34(11):6283-8.</citation>
    <PMID>25368226</PMID>
  </reference>
  <reference>
    <citation>Martin RC 2nd, Jaques DP, Brennan MF, Karpeh M. Achieving RO resection for locally advanced gastric cancer: is it worth the risk of multiorgan resection? J Am Coll Surg. 2002 May;194(5):568-77. doi: 10.1016/s1072-7515(02)01116-x.</citation>
    <PMID>12025834</PMID>
  </reference>
  <reference>
    <citation>Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390.</citation>
    <PMID>19001484</PMID>
  </reference>
  <results_reference>
    <citation>Orsenigo E, Bissolati M, Socci C, Chiari D, Muffatti F, Nifosi J, Staudacher C. Duodenal stump fistula after gastric surgery for malignancies: a retrospective analysis of risk factors in a single centre experience. Gastric Cancer. 2014 Oct;17(4):733-44. doi: 10.1007/s10120-013-0327-x. Epub 2014 Jan 8.</citation>
    <PMID>24399492</PMID>
  </results_reference>
  <results_reference>
    <citation>Cozzaglio L, Coladonato M, Biffi R, Coniglio A, Corso V, Dionigi P, Gianotti L, Mazzaferro V, Morgagni P, Rosa F, Rosati R, Roviello F, Doci R. Duodenal fistula after elective gastrectomy for malignant disease : an italian retrospective multicenter study. J Gastrointest Surg. 2010 May;14(5):805-11. doi: 10.1007/s11605-010-1166-2. Epub 2010 Feb 9.</citation>
    <PMID>20143272</PMID>
  </results_reference>
  <results_reference>
    <citation>Rossi JA, Sollenberger LL, Rege RV, Glenn J, Joehl RJ. External duodenal fistula. Causes, complications, and treatment. Arch Surg. 1986 Aug;121(8):908-12. doi: 10.1001/archsurg.1986.01400080050009.</citation>
    <PMID>3729708</PMID>
  </results_reference>
  <results_reference>
    <citation>EDMUNDS LH Jr, WILLIAMS GM, WELCH CE. External fistulas arising from the gastro-intestinal tract. Ann Surg. 1960 Sep;152(3):445-71. doi: 10.1097/00000658-196009000-00009. No abstract available.</citation>
    <PMID>13725742</PMID>
  </results_reference>
  <results_reference>
    <citation>Tarazi R, Coutsoftides T, Steiger E, Fazio VW. Gastric and duodenal cutaneous fistulas. World J Surg. 1983 Jul;7(4):463-73. doi: 10.1007/BF01655935. No abstract available.</citation>
    <PMID>6624121</PMID>
  </results_reference>
  <results_reference>
    <citation>Kim W, Kim HH, Han SU, Kim MC, Hyung WJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Lee HJ; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01). Ann Surg. 2016 Jan;263(1):28-35. doi: 10.1097/SLA.0000000000001346.</citation>
    <PMID>26352529</PMID>
  </results_reference>
  <results_reference>
    <citation>Pedrazzani C, Marrelli D, Rampone B, De Stefano A, Corso G, Fotia G, Pinto E, Roviello F. Postoperative complications and functional results after subtotal gastrectomy with Billroth II reconstruction for primary gastric cancer. Dig Dis Sci. 2007 Aug;52(8):1757-63. doi: 10.1007/s10620-006-9655-6. Epub 2007 Apr 3.</citation>
    <PMID>17404848</PMID>
  </results_reference>
  <results_reference>
    <citation>McCulloch P, Ward J, Tekkis PP; ASCOT group of surgeons; British Oesophago-Gastric Cancer Group. Mortality and morbidity in gastro-oesophageal cancer surgery: initial results of ASCOT multicentre prospective cohort study. BMJ. 2003 Nov 22;327(7425):1192-7. doi: 10.1136/bmj.327.7425.1192.</citation>
    <PMID>14630753</PMID>
  </results_reference>
  <results_reference>
    <citation>Cozzaglio L, Cimino M, Mauri G, Ardito A, Pedicini V, Poretti D, Brambilla G, Sacchi M, Melis A, Doci R. Percutaneous transhepatic biliary drainage and occlusion balloon in the management of duodenal stump fistula. J Gastrointest Surg. 2011 Nov;15(11):1977-81. doi: 10.1007/s11605-011-1668-6. Epub 2011 Sep 13.</citation>
    <PMID>21913043</PMID>
  </results_reference>
  <results_reference>
    <citation>Levy E, Cugnenc PH, Frileux P, Hannoun L, Parc R, Huguet C, Loygue J. Postoperative peritonitis due to gastric and duodenal fistulas. Operative management by continuous intraluminal infusion and aspiration: report of 23 cases. Br J Surg. 1984 Jul;71(7):543-6. doi: 10.1002/bjs.1800710725.</citation>
    <PMID>6733430</PMID>
  </results_reference>
  <results_reference>
    <citation>Isik B, Yilmaz S, Kirimlioglu V, Sogutlu G, Yilmaz M, Katz D. A life-saving but inadequately discussed procedure: tube duodenostomy. Known and unknown aspects. World J Surg. 2007 Aug;31(8):1616-24; discussion 1625-6. doi: 10.1007/s00268-007-9114-3.</citation>
    <PMID>17566821</PMID>
  </results_reference>
  <results_reference>
    <citation>Chander J, Lal P, Ramteke VK. Rectus abdominis muscle flap for high-output duodenal fistula: novel technique. World J Surg. 2004 Feb;28(2):179-82. doi: 10.1007/s00268-003-7017-5. Epub 2004 Jan 20.</citation>
    <PMID>14727065</PMID>
  </results_reference>
  <results_reference>
    <citation>Ujiki GT, Shields TW. Roux-en-Y operation in the management of postoperative fistula. Arch Surg. 1981 May;116(5):614-7. doi: 10.1001/archsurg.1981.01380170094017.</citation>
    <PMID>7235954</PMID>
  </results_reference>
  <results_reference>
    <citation>Milias K, Deligiannidis N, Papavramidis TS, Ioannidis K, Xiros N, Papavramidis S. Biliogastric diversion for the management of high-output duodenal fistula: report of two cases and literature review. J Gastrointest Surg. 2009 Feb;13(2):299-303. doi: 10.1007/s11605-008-0677-6. Epub 2008 Sep 30.</citation>
    <PMID>18825468</PMID>
  </results_reference>
  <results_reference>
    <citation>Musicant ME, Thompson JC. The emergency management of lateral duodenal fistula by pancreaticoduodenectomy. Surg Gynecol Obstet. 1969 Jan;128(1):108-14. No abstract available.</citation>
    <PMID>5774989</PMID>
  </results_reference>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 6, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>September 15, 2017</last_update_submitted>
  <last_update_submitted_qc>September 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Turin, Italy</investigator_affiliation>
    <investigator_full_name>Maurizio Degiuli</investigator_full_name>
    <investigator_title>Associate Professor, Head Surgical Oncology</investigator_title>
  </responsible_party>
  <keyword>linear stapler</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stomach Neoplasms</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03277144
org study id: DRTST.01
nct id: NCT03277144
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The goal of this trial is to demonstrate that the use of Tri-Staple Technology for duodenal
      resection during open gastrectomy for cancer is safer than the use of other conventional
      methods of resection/closure of the duodenum and that the incidence of duodenal fistula can
      be decreased to that observed after the use of this technology in Laparoscopic and robotic
      gastrectomy, therefore almost three times lower than that currently reported in literature.

      Participating centres must have an annual volume of at least 20 gastrectomies per year.
BACKGROUND Gastric cancer is still one of the most frequent malignancies in Europe. In United
      States the estimated new cases in 2010 were 21000 (12730 male and 8270 female) with 10570
      estimated deaths (6350 male and 4220 female)[7,8]. In Italy the estimated new cases in 2013
      were 13200 (7900 males and 5300 female) (AIOM-AIRTUM, I numeri del cancro in Italia - 2013,
      www.registri-tumori.it) .The incidence rates in 2005-2009 were 21.6 and 10.8 per 100,000 in
      males and females respectively. The mortality rates in 2005-2009 were 14.9 and 7.3 per
      100,000 in males and females respectively. (www.itacan.ispo.toscana.it).A total or subtotal
      gastrectomy with D2 lymph node dissection and R0 margins remains the standard of care for
      gastric cancer[9,10]. Despite this, in low-volume centers gastrectomy still remains a
      challenging procedure with a notable morbidity rate (33%-43%) and mortality rate
      (7%-12%)[11,12]. Duodenal stump fistula (DSF) represents an infrequent but severe
      complication after total or subtotal gastrectomy for gastric cancer, with incidence of 2,5 -
      5% and mortality rate ranging from 7% to 67%(1-5). Several factors were identified as
      possible cause of DSF, such as local hematoma, inflammation, intra-operative inadequate
      closure of the duodenal stump, incorrect drain position, devascularization, post-operative
      distension of the duodenum and R1-R2 resections[2,13].

      There are many DSF-related complications leading to longer hospitalization times, such as
      intra-abdominal abscesses, wound infections, diffuse peritonitis, sepsis, malnutrition,
      pancreatitis, abdominal bleeding, and pneumonia. (3) DSF is often difficult to treat because
      of the highly enzyme-rich duodenal juice and deep location of the fistula. In a retrospective
      multicenter study (2) 3,685 patients undergoing gastrectomy for malignancies who developed 68
      DSFs were analyzed; it was reported that DSF features had changed in the last 30 years and
      that DSF alone no longer leads to death; some complications observed in the past, such as
      fluid and electrolyte loss and dermatitis, have disappeared owing to improvements( in
      particular parenteral nutrition and wound care). However, additional new complications such
      as bleeding and fistulas of neighboring organs were emerging. Although medical therapy is
      associated with better outcomes, surgery is still mandatory in cases of severe abdominal
      sepsis or bleeding not otherwise manageable.

      However, reoperation is often ineffective owing to postoperative edema and inflammation, and
      the prognosis of patients undergoing surgery for DSF remains very poor. To improve the
      outcome of these patients, many surgical procedures have been proposed from washing the
      peritoneal cavity and abdominal drainage to tube duodenostomy (14,15), closure of the
      fistula, fistula repair with a rectus abdominis flap (16), fistula closure by Roux-en-Y
      duodenojejunostomy(17,18), biliogastric diversion, laparostomy, and pancreatoduodenectomy
      (19) but surgeons are often unsure about the best management and the result are often
      unsuccessful.

      In a recent Korean national RCT (6) on open (ODG) vs laparoscopic distal gastrectomy (LADG),
      the incidence of duodenal stump leakage after laparoscopyc gastrectomy was about 1%; in this
      population study the use of tri-staple technology for duodenal resection was mandatory. In
      our clinical practice, the incidence of DSF after open gastrectomy is about 3-5% adopting
      different techniques of duodenal stump resection/closure.

      The aim of this study is to evaluate if duodenal stump resection/closure using tri-staple
      technology can significantly decrease the incidence of DSF after open gastrectomy as compared
      to the other conventional methods adopted in the clinical practice (1% vs 5%).

      We have designed a national multicentre pragmatic (20) RCT to compare the use of endoGIA or
      Echelon (triStaple technology) to other conventional methods (GIA with or without manual
      reinforcement , manual suture, purse string) for duodenal resection/closure during open
      gastrectomy, with the assumption that Tri-staple technology without reinforcement ( as
      routinely used in LADG) is the safest method.

      AIM OF THE STUDY The goal of this trial is to demonstrate that the use of Tri-Staple
      Technology for duodenal resection during open gastrectomy for cancer is safer than the use of
      other conventional methods of resection/closure of the duodenum and that the incidence of
      duodenal fistula can be decreased to that observed after the use of this technology in
      Laparoscopic and robotic gastrectomy, therefore almost three times lower than that currently
      reported in literature.

      Participating centres must have an annual volume of at least 20 gastrectomies per year.

      Design of the study This is a multicentre randomized controlled trial.

      Patients with malignant tumor of the stomach, as primary diagnosis, requiring distal or total
      gastrectomy without anastomosis with the duodenum will undergo clinical preoperative workout
      and anaesthesiologist evaluation. All patients who meet the inclusion/exclusion criteria and
      agree to sign the informed consent are registered into the trial and randomized to one of the
      two arms (a. Duodenal Stump Closure with TriStaple Technology - TST or b. Duodenal Stump
      closure with other conventional techniques - OCT ) as described in the chapter Randomization.
      In TST arm no manual reinforce of the mechanical suture should be perfomed; in OCT group, a
      manual reinforce of the suture can be done according to the preference of the operator, and
      recorded in the trial data base (DB).

      Patients' postoperative course will be carefully monitored and all variables detailed below
      will be recorded in the DB.

      DSF will be diagnosed by the presence of duodenal fluid in the surgical drainage and
      confirmed by a CT scan when needed (presence of intra-abdominal peri-duodenal collection of
      fluid and/or micro air bubbles).

      Also the type of treatment (conservative, percutaneous drainage, reoperation, others ) of DSF
      should be recorded, as well as the length of hospital stay and other postoperative
      complications or in-hospital death ( as well as 30- and 90- days mortality)

      Trial setting

      This is an Italian national multicentre RCT; the Division of General Surgery from University
      of Turin, Department of Surgical Sciences, AOU San Luigi Gonzaga di Orbassano, will be the
      Coordinating Centre of the trial. The P.I. of the trial is Prof Maurizio Degiuli.

      S.S.D. Epidemiologia, Clinica e Valutativa, AOU Città della Salute e della Scienza di Torino,
      will be responsible for this trial's central randomisation and statistical analysis.

      Clinical monitoring and data managing will be performed by the P.I. and and co-investigators.

      Study population

      inclusion criteria

      pathologically proven malign tumor of the stomach age of 18 to 80 years, no history of other
      cancers no history of radiotherapy in supra-mesocolic space total or distal gastrectomy
      without anastomosis with the duodenum

      exclusion criteria

      emergency surgery American Society of Anesthesiologists class > 3 need for combined resection
      of other organs laparoscopic/robotic access severe heart disease liver cirrhosis T stage
      >cT4a citology positive at preoperative laparoscopy cM+ cD+

      All patients freely give informed consent to participate in the study prior to surgery, at
      the time of discussing the intervention with the surgeon or the nurse and can decide to
      withdraw from the study at any time.

      Diagnosis of DSF

      A diagnosis of DF is made on the basis of the presence of duodenal juice in the surgical
      drainage or its leakage through the abdominal wall, and confirmed by CT scan and/or
      fistulography.

      Variables

      sex age ASA score COPD type 2 DM multiple comorbidities pre-operative albumin serum levels
      pre-operative lymphocytes blood count cT Stage / pTStage pTNM distal margin involvement
      intraoperative blood loss lenght of hospital stay Type of gastrectomy TG vs DG type of
      reconstruction: ( BII vs RY) lymph node dissection: D1, D1+, D2, > D2

      Type of duodenal stump closure device:

      A. endoGIA tristaple B. other techniques (GIA/TA with or without manual reinforcement (simple
      interrupted suture or running suture), manual suture (simple interrupted or running suture),
      purse string)

      Development of DSF (po day) healing of DSF (po day) Diagnosis of DSF Daily output of DSF Type
      of treatment of DSF Other postoperative morbidity according to Dindo. Postoperative mortality

      Randomisation

      All patients who meet the inclusion/exclusion criteria and give the informed consent to
      participate are registered into the central trial database and centrally randomized to one of
      the two groups (a. Duodenal Stump Closure with TriStaple Technology - TST or b. Duodenal
      Stump closure with other conventional techniques - OCT ).

      Patients refusing recruitment are treated with usual care and contribute to the database a
      limited set of pre-defined information.

      Result of randomisation is communicated to the surgical team at the time of their entrance in
      the surgical theatre.

      Sample size calculation and statistical analysis

      Assuming an alpha error at the 5% level and power 80%, a total of 700 patients (350 per arm)
      are required in order to recognise a true difference of 5% in (a) vs 1% in (b).

      Assuming an average case volume of 20 patients per year and 60% acceptance rate, about 30
      Centres recruiting for two years will need to be involved.

      Cox regression with multivariable analysis will be performed

      Data property

      Results will be the property of Università degli studi di Torino and of the researchers
      involved in the conduction of the mulicentre project. A scientific committee will be
      constituted comprising a lead investigator from each of the Centres.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All gastric cancer patients who meet the inclusion/exclusion criteria and give the informed consent to participate are registered into the central trial database and centrally permuted-block randomized to one of the two arms (a. Duodenal Stump Closure with TriStaple Technology - TST or b. Duodenal Stump closure with other conventional techniques - OCT ).
primary purpose: Prevention
masking: None (Open Label)
measure: incidence of duodenal stump leak
time frame: within 30/60 days from operation
description: The aim of this study is to evaluate if duodenal stump closure using tri-staple technology can significantly decrease the incidence of duodenal stump leakage to 1% as compared to other conventional methods (5%). So the primary endpoint is :
- incidence of DSF, diagnosed on the basis of the presence of duodenal juice in the surgical drainage or its leakage through the abdominal wall, and confirmed by CT scan and/or fistulography.
measure: cost of surgery
time frame: within 90 days from operation
description: cost of devices, hospital stay, drugs, examinations
measure: operative time for duodenal stump closure
time frame: intraopeartively
description: time ( min) necessary for duodenal stump closure
measure: short-term postoperative complications
time frame: within 30 days from operation
description: onset of postoperative complications according to Clavien-Dindo classification
measure: blood loss
time frame: intraopeartively
description: intraoperative blood loss (ml)
measure: lenght of hospitalization
time frame: 120 days after operation
description: duration (days) of hospital stay after operation
measure: Operative mortality
time frame: 30 and 60 days after operation
description: post-operative death
measure: Frequency of DSF by surgical volume
time frame: one year
description: rate of duodenal stump leak of every participating center
arm group label: TST-TriStaple(3lines stapler)Technology
arm group type: Experimental
description: During gastrectomy for gatric cancer without anastomosis with the duodenum, Duodenal Stump is closed with a TriStaple (three-lines linear stapler) Technology device.
arm group label: OCT (other conventional techniques)
arm group type: Active Comparator
description: During gastrectomy for gatric cancer without anastomosis with the duodenum, Duodenal Stump is closed with conventional techniques including manual sutures and devices with only two lines of staples.
intervention type: Device
intervention name: TST-TriStaple(3lines stapler)Technology
description: Duodenal stump closed using a Tristaple ( three-lines linear stapler) device
arm group label: TST-TriStaple(3lines stapler)Technology
intervention type: Other
intervention name: other conventional techniques
description: Duodenal stump closed using other conventional techniques entailing manual suture or mechanical devices with only two lines of sutures.
arm group label: OCT (other conventional techniques)
other name: double-line linear stapler with manual reinforcement
other name: manual suture
other name: purse string suture
other name: double-line linear stapler without manual reinforcement
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Maurizio Degiuli, MD Prof
role: Principal Investigator
affiliation: University of Turin, San Luigi University Hospital
last name: Rossella Reddavid, MD
phone: +393479848651
email: rossella.reddavid@gmail.com
last name: Andrea Evangelista
phone: +390116336855
email: andre.evangelist@cpo.it
facility: 
status: Recruiting
contact: 
country: Italy
citation: Inghelmann R, Grande E, Francisci S, Verdecchia A, Micheli A, Baili P, Capocaccia R, De Angelis R. Regional estimates of stomach cancer burden in Italy. Tumori. 2007 Jul-Aug;93(4):367-73. doi: 10.1177/030089160709300407.
PMID: 17899867
citation: Aurello P, Bellagamba R, Rossi Del Monte S, D'Angelo F, Nigri G, Cicchini C, Ravaioli M, Ramacciato G. Apoptosis and microvessel density in gastric cancer: correlation with tumor stage and prognosis. Am Surg. 2009 Dec;75(12):1183-8.
PMID: 19999909
citation: Aurello P, Magistri P, Nigri G, Petrucciani N, Novi L, Antolino L, D'Angelo F, Ramacciato G. Surgical management of microscopic positive resection margin after gastrectomy for gastric cancer: a systematic review of gastric R1 management. Anticancer Res. 2014 Nov;34(11):6283-8.
PMID: 25368226
citation: Martin RC 2nd, Jaques DP, Brennan MF, Karpeh M. Achieving RO resection for locally advanced gastric cancer: is it worth the risk of multiorgan resection? J Am Coll Surg. 2002 May;194(5):568-77. doi: 10.1016/s1072-7515(02)01116-x.
PMID: 12025834
citation: Zwarenstein M, Treweek S, Gagnier JJ, Altman DG, Tunis S, Haynes B, Oxman AD, Moher D; CONSORT group; Pragmatic Trials in Healthcare (Practihc) group. Improving the reporting of pragmatic trials: an extension of the CONSORT statement. BMJ. 2008 Nov 11;337:a2390. doi: 10.1136/bmj.a2390.
PMID: 19001484
citation: Orsenigo E, Bissolati M, Socci C, Chiari D, Muffatti F, Nifosi J, Staudacher C. Duodenal stump fistula after gastric surgery for malignancies: a retrospective analysis of risk factors in a single centre experience. Gastric Cancer. 2014 Oct;17(4):733-44. doi: 10.1007/s10120-013-0327-x. Epub 2014 Jan 8.
PMID: 24399492
citation: Cozzaglio L, Coladonato M, Biffi R, Coniglio A, Corso V, Dionigi P, Gianotti L, Mazzaferro V, Morgagni P, Rosa F, Rosati R, Roviello F, Doci R. Duodenal fistula after elective gastrectomy for malignant disease : an italian retrospective multicenter study. J Gastrointest Surg. 2010 May;14(5):805-11. doi: 10.1007/s11605-010-1166-2. Epub 2010 Feb 9.
PMID: 20143272
citation: Rossi JA, Sollenberger LL, Rege RV, Glenn J, Joehl RJ. External duodenal fistula. Causes, complications, and treatment. Arch Surg. 1986 Aug;121(8):908-12. doi: 10.1001/archsurg.1986.01400080050009.
PMID: 3729708
citation: EDMUNDS LH Jr, WILLIAMS GM, WELCH CE. External fistulas arising from the gastro-intestinal tract. Ann Surg. 1960 Sep;152(3):445-71. doi: 10.1097/00000658-196009000-00009. No abstract available.
PMID: 13725742
citation: Tarazi R, Coutsoftides T, Steiger E, Fazio VW. Gastric and duodenal cutaneous fistulas. World J Surg. 1983 Jul;7(4):463-73. doi: 10.1007/BF01655935. No abstract available.
PMID: 6624121
citation: Kim W, Kim HH, Han SU, Kim MC, Hyung WJ, Ryu SW, Cho GS, Kim CY, Yang HK, Park DJ, Song KY, Lee SI, Ryu SY, Lee JH, Lee HJ; Korean Laparo-endoscopic Gastrointestinal Surgery Study (KLASS) Group. Decreased Morbidity of Laparoscopic Distal Gastrectomy Compared With Open Distal Gastrectomy for Stage I Gastric Cancer: Short-term Outcomes From a Multicenter Randomized Controlled Trial (KLASS-01). Ann Surg. 2016 Jan;263(1):28-35. doi: 10.1097/SLA.0000000000001346.
PMID: 26352529
citation: Pedrazzani C, Marrelli D, Rampone B, De Stefano A, Corso G, Fotia G, Pinto E, Roviello F. Postoperative complications and functional results after subtotal gastrectomy with Billroth II reconstruction for primary gastric cancer. Dig Dis Sci. 2007 Aug;52(8):1757-63. doi: 10.1007/s10620-006-9655-6. Epub 2007 Apr 3.
PMID: 17404848
citation: McCulloch P, Ward J, Tekkis PP; ASCOT group of surgeons; British Oesophago-Gastric Cancer Group. Mortality and morbidity in gastro-oesophageal cancer surgery: initial results of ASCOT multicentre prospective cohort study. BMJ. 2003 Nov 22;327(7425):1192-7. doi: 10.1136/bmj.327.7425.1192.
PMID: 14630753
citation: Cozzaglio L, Cimino M, Mauri G, Ardito A, Pedicini V, Poretti D, Brambilla G, Sacchi M, Melis A, Doci R. Percutaneous transhepatic biliary drainage and occlusion balloon in the management of duodenal stump fistula. J Gastrointest Surg. 2011 Nov;15(11):1977-81. doi: 10.1007/s11605-011-1668-6. Epub 2011 Sep 13.
PMID: 21913043
citation: Levy E, Cugnenc PH, Frileux P, Hannoun L, Parc R, Huguet C, Loygue J. Postoperative peritonitis due to gastric and duodenal fistulas. Operative management by continuous intraluminal infusion and aspiration: report of 23 cases. Br J Surg. 1984 Jul;71(7):543-6. doi: 10.1002/bjs.1800710725.
PMID: 6733430
citation: Isik B, Yilmaz S, Kirimlioglu V, Sogutlu G, Yilmaz M, Katz D. A life-saving but inadequately discussed procedure: tube duodenostomy. Known and unknown aspects. World J Surg. 2007 Aug;31(8):1616-24; discussion 1625-6. doi: 10.1007/s00268-007-9114-3.
PMID: 17566821
citation: Chander J, Lal P, Ramteke VK. Rectus abdominis muscle flap for high-output duodenal fistula: novel technique. World J Surg. 2004 Feb;28(2):179-82. doi: 10.1007/s00268-003-7017-5. Epub 2004 Jan 20.
PMID: 14727065
citation: Ujiki GT, Shields TW. Roux-en-Y operation in the management of postoperative fistula. Arch Surg. 1981 May;116(5):614-7. doi: 10.1001/archsurg.1981.01380170094017.
PMID: 7235954
citation: Milias K, Deligiannidis N, Papavramidis TS, Ioannidis K, Xiros N, Papavramidis S. Biliogastric diversion for the management of high-output duodenal fistula: report of two cases and literature review. J Gastrointest Surg. 2009 Feb;13(2):299-303. doi: 10.1007/s11605-008-0677-6. Epub 2008 Sep 30.
PMID: 18825468
citation: Musicant ME, Thompson JC. The emergency management of lateral duodenal fistula by pancreaticoduodenectomy. Surg Gynecol Obstet. 1969 Jan;128(1):108-14. No abstract available.
PMID: 5774989
responsible party type: Principal Investigator
investigator affiliation: University of Turin, Italy
investigator full name: Maurizio Degiuli
investigator title: Associate Professor, Head Surgical Oncology
mesh term: Stomach Neoplasms
mesh term: Fistula
sharing ipd: No