<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/NCT03800940</url>
  </required_header>
  <id_info>
    <org_study_id>201809040RIND</org_study_id>
    <nct_id>NCT03800940</nct_id>
  </id_info>
  <brief_title>Trans-drain Occlusion for Postoperative Pancreatic Fistula- A Double Blind Randomized Clinical Trial</brief_title>
  <official_title>Trans-drain Occlusion for Postoperative Pancreatic Fistula- A Double Blind Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, investigator initiated, prospective, superiority, parallel-group,&#xD;
      randomized, double-blinded trial that aims to compare the efficacy and safety of trans-drain&#xD;
      occlusion followed by gradual withdrawal of drain versus gradual withdrawal of drain alone&#xD;
      for postoperative pancreatic fistula (POPF) that persists for longer than 21 days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The most common major complication after pancreatic resection is postoperative pancreatic&#xD;
      fistula (POPF), which is defined as a drain output of any measurable volume of fluid on and&#xD;
      after postoperative day 3 with an amylase content &gt; 3 times the upper limit of normal serum&#xD;
      level. Gradual withdrawal of surgically placed drains in patients who are clinically stable&#xD;
      and tolerate a diet is generally adopted to hasten closure of POPF. For high-output fistulas&#xD;
      (&gt; 150-200 mL of amylase-rich fluid per day), patients are initially managed with fasting and&#xD;
      enteral or parenteral nutrition. If fistula output decreases substantially with these&#xD;
      measures and the patient remains clinically well, drain withdrawal is initiated and oral&#xD;
      intake is slowly restarted. If the patient remains well despite high fistula output, drains&#xD;
      are slowly withdrawn in an attempt to decrease the output and close the fistula. When the&#xD;
      output decrease to less than 10 mL per day, the drains are removed.&#xD;
&#xD;
      However, the current standard practice of gradual drain withdrawal is time consuming.&#xD;
      Although clinically stable can be discharged with the drain, the drainage tube often remains&#xD;
      in place for a prolonged period, with patient discomfort and increased medical cost. In a&#xD;
      pilot study by the investigators, 32.5% (37/114) of POPF patients required drainage for&#xD;
      longer than 21 days. Besides, there is also considerable risk of recurrent fluid collection&#xD;
      along the drain tube tract after drain removal.&#xD;
&#xD;
      The investigators' experience has shown that trans-drain occlusion of the drain tract&#xD;
      achieves fistula closure, enabling immediate removal of the drain. In a pilot study, 20&#xD;
      patients underwent trans-catheter occlusion for POPFs that persisted for more than 3 weeks&#xD;
      after placement of drainage tubes. No subjective symptoms or abnormalities in blood tests&#xD;
      were noted in 17 patients after the procedure. Three patients had abdominal pain without&#xD;
      signs of infection, and the pain spontaneously subsided after conservative treatment. POPF&#xD;
      healed immediately after occlusion in all of the 20 patients without recurrence during&#xD;
      follow-up. This multicenter, investigator initiated, prospective, superiority,&#xD;
      parallel-group, randomized, double-blinded trial aims to compare the efficacy and safety of&#xD;
      trans-drain occlusion followed by gradual withdrawal of drain versus gradual withdrawal of&#xD;
      drain alone for POPF that persists for longer than 21 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 11, 2019</start_date>
  <completion_date type="Actual">March 27, 2023</completion_date>
  <primary_completion_date type="Actual">November 27, 2022</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>Enrolled patients will be randomly assigned in a 2:1 ratio to receive trans-drain occlusion followed by gradual drain withdrawal or gradual drain withdrawal.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Days to fistula closure</measure>
    <time_frame>The date of fistula closure is the date on which the drain is removed after an output of ≦ 10 mL during 48 hours, without recurrence of fistula within the next 3 months</time_frame>
    <description>Days from the randomly allocated treatment to fistula closure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>30-day fistula closure rate</measure>
    <time_frame>From enrollment to 4 months after fistula occurrence</time_frame>
    <description>Proportion of patients in whom the drain can be removed by 30 days after occurrence of fistula, without recurrence within the next 3 months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of persistent or recurrent POPF after initial drain removal</measure>
    <time_frame>From drain removal to 3 months after drain removal or recurrence of fistula, whichever occurs first</time_frame>
    <description>Proportion of patients with fluid collection on follow-up CT, which is to be performed at 3 months after removal of drain or when recurrence of fistula is suspected clinically.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay after the assigned treatment</measure>
    <time_frame>From treatment to discharge from the index admission, an average of 2 weeks</time_frame>
    <description>Days from the assigned treatment to discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital costs after the assigned treatment</measure>
    <time_frame>From treatment to discharge from the index admission, an average of 2 weeks</time_frame>
    <description>Costs from the assigned treatment to discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of fistula-related complications</measure>
    <time_frame>From occurrence of fistula to 3 months after drain removal</time_frame>
    <description>Proportion of patients who develop fever/infection, ileus, postpancreatectomy hemorrhage from the assigned treatment to end of follow-up.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Incidence of Treatment-Emergent Adverse Events</measure>
    <time_frame>From treatment to discharge from the index admission, an average of 2 weeks</time_frame>
    <description>Fever/infection or pain that develops within 48 hours after the allocated treatment, or any adverse events judged to be related to the treatment</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Pancreatic Fistula</condition>
  <arm_group>
    <arm_group_label>Fistulography and trans-drain occlusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Fistulography is performed to assess the condition of the fistula, and trans-drain occlusion is performed by injecting glue (NBCA and Lipiodol) through the drain to occlude the tract.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fistulography</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Fistulography is performed to assess the condition of the fistula, without trains-drain occlusion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fistulography and trans-drain occlusion</intervention_name>
    <description>Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube.&#xD;
Trans-drain occlusion: a 0.035-inch guidewire is inserted via the puncture needle. The drain tube is removed, cut at 4 cm proximal to the skin fixation site, and preserved for reinsertion. After inserting a 40cm 5Fr KMP catheter over the guidewire, the guidewire is removed. Afte rinsing the KMP catheter with 3ml 5% glucose water, withdraw the catheter and simultaneously inject glue (33%, 1:2, 0.5ml of NBCA + 1ml Lipiodol) into the catheter until the proximal 5cm of the catheter remains inside the tract. The guidewire is re-inserted through the catheter, and then the original drain tube is re-inserted over the guidewire. The guidewire is removed and the drain is fixed.</description>
    <arm_group_label>Fistulography and trans-drain occlusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fistulography</intervention_name>
    <description>Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube.</description>
    <arm_group_label>Fistulography</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who undergo pancreatectomy (including pancreatoduodenectomy with or without&#xD;
             pylorus preservation, distal pancreatectomy, and central pancreatectomy) and develop&#xD;
             POPF that persists for 3 weeks after its occurrence.&#xD;
&#xD;
          -  With POPF that persists for 3 weeks after occurrence&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Younger than 20 years of age&#xD;
&#xD;
          -  Active infection not adequately controlled [body temperature ≧38.5℃ and/or eukocytosis&#xD;
             (WBC count &gt;15,000 /uL)/leukopenia (WBC count &lt;4,000 /uL)], have residual&#xD;
             intra-abdominal fluid collection (largest diameter &gt; 4cm) despite tube drainage on CT&#xD;
             scan (with or without contrast, performed when the patient meet inclusion criteria).&#xD;
&#xD;
          -  Current or history of severe heart, lung, kidney, or liver failure&#xD;
&#xD;
          -  Karnofsky Performance Score &lt;60&#xD;
&#xD;
          -  Pregnant or lactating&#xD;
&#xD;
          -  Have received somatostatin or its analogue in the index admission&#xD;
&#xD;
          -  Decline to participate&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yu-Wen Tien, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Taiwan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <reference>
    <citation>Schlitt HJ, Schmidt U, Simunec D, Jager M, Aselmann H, Neipp M, Piso P. Morbidity and mortality associated with pancreatogastrostomy and pancreatojejunostomy following partial pancreatoduodenectomy. Br J Surg. 2002 Oct;89(10):1245-51. doi: 10.1046/j.1365-2168.2002.02202.x.</citation>
    <PMID>12296891</PMID>
  </reference>
  <reference>
    <citation>Balcom JH 4th, Rattner DW, Warshaw AL, Chang Y, Fernandez-del Castillo C. Ten-year experience with 733 pancreatic resections: changing indications, older patients, and decreasing length of hospitalization. Arch Surg. 2001 Apr;136(4):391-8. doi: 10.1001/archsurg.136.4.391.</citation>
    <PMID>11296108</PMID>
  </reference>
  <reference>
    <citation>Yeo CJ, Cameron JL, Sohn TA, Lillemoe KD, Pitt HA, Talamini MA, Hruban RH, Ord SE, Sauter PK, Coleman J, Zahurak ML, Grochow LB, Abrams RA. Six hundred fifty consecutive pancreaticoduodenectomies in the 1990s: pathology, complications, and outcomes. Ann Surg. 1997 Sep;226(3):248-57; discussion 257-60. doi: 10.1097/00000658-199709000-00004.</citation>
    <PMID>9339931</PMID>
  </reference>
  <reference>
    <citation>Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CR, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.</citation>
    <PMID>28040257</PMID>
  </reference>
  <reference>
    <citation>Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.</citation>
    <PMID>16003309</PMID>
  </reference>
  <reference>
    <citation>Roberts KJ, Sutcliffe RP, Marudanayagam R, Hodson J, Isaac J, Muiesan P, Navarro A, Patel K, Jah A, Napetti S, Adair A, Lazaridis S, Prachalias A, Shingler G, Al-Sarireh B, Storey R, Smith AM, Shah N, Fusai G, Ahmed J, Abu Hilal M, Mirza DF. Scoring System to Predict Pancreatic Fistula After Pancreaticoduodenectomy: A UK Multicenter Study. Ann Surg. 2015 Jun;261(6):1191-7. doi: 10.1097/SLA.0000000000000997.</citation>
    <PMID>25371115</PMID>
  </reference>
  <reference>
    <citation>El Nakeeb A, Salah T, Sultan A, El Hemaly M, Askr W, Ezzat H, Hamdy E, Atef E, El Hanafy E, El-Geidie A, Abdel Wahab M, Abdallah T. Pancreatic anastomotic leakage after pancreaticoduodenectomy. Risk factors, clinical predictors, and management (single center experience). World J Surg. 2013 Jun;37(6):1405-18. doi: 10.1007/s00268-013-1998-5.</citation>
    <PMID>23494109</PMID>
  </reference>
  <reference>
    <citation>Veillette G, Dominguez I, Ferrone C, Thayer SP, McGrath D, Warshaw AL, Fernandez-del Castillo C. Implications and management of pancreatic fistulas following pancreaticoduodenectomy: the Massachusetts General Hospital experience. Arch Surg. 2008 May;143(5):476-81. doi: 10.1001/archsurg.143.5.476.</citation>
    <PMID>18490557</PMID>
  </reference>
  <reference>
    <citation>McMillan MT, Soi S, Asbun HJ, Ball CG, Bassi C, Beane JD, Behrman SW, Berger AC, Bloomston M, Callery MP, Christein JD, Dixon E, Drebin JA, Castillo CF, Fisher WE, Fong ZV, House MG, Hughes SJ, Kent TS, Kunstman JW, Malleo G, Miller BC, Salem RR, Soares K, Valero V, Wolfgang CL, Vollmer CM Jr. Risk-adjusted Outcomes of Clinically Relevant Pancreatic Fistula Following Pancreatoduodenectomy: A Model for Performance Evaluation. Ann Surg. 2016 Aug;264(2):344-52. doi: 10.1097/SLA.0000000000001537.</citation>
    <PMID>26727086</PMID>
  </reference>
  <reference>
    <citation>Diener MK, Seiler CM, Rossion I, Kleeff J, Glanemann M, Butturini G, Tomazic A, Bruns CJ, Busch OR, Farkas S, Belyaev O, Neoptolemos JP, Halloran C, Keck T, Niedergethmann M, Gellert K, Witzigmann H, Kollmar O, Langer P, Steger U, Neudecker J, Berrevoet F, Ganzera S, Heiss MM, Luntz SP, Bruckner T, Kieser M, Buchler MW. Efficacy of stapler versus hand-sewn closure after distal pancreatectomy (DISPACT): a randomised, controlled multicentre trial. Lancet. 2011 Apr 30;377(9776):1514-22. doi: 10.1016/S0140-6736(11)60237-7.</citation>
    <PMID>21529927</PMID>
  </reference>
  <reference>
    <citation>Tjaden C, Hinz U, Hassenpflug M, Fritz F, Fritz S, Grenacher L, Buchler MW, Hackert T. Fluid collection after distal pancreatectomy: a frequent finding. HPB (Oxford). 2016 Jan;18(1):35-40. doi: 10.1016/j.hpb.2015.10.006. Epub 2015 Nov 18.</citation>
    <PMID>26776849</PMID>
  </reference>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>January 2, 2019</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>March 27, 2023</last_update_submitted>
  <last_update_submitted_qc>March 27, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 28, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pancreatic Fistula</mesh_term>
    <mesh_term>Fistula</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 27, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT03800940/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03800940
org study id: 201809040RIND
nct id: NCT03800940
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a multicenter, investigator initiated, prospective, superiority, parallel-group,
      randomized, double-blinded trial that aims to compare the efficacy and safety of trans-drain
      occlusion followed by gradual withdrawal of drain versus gradual withdrawal of drain alone
      for postoperative pancreatic fistula (POPF) that persists for longer than 21 days.
The most common major complication after pancreatic resection is postoperative pancreatic
      fistula (POPF), which is defined as a drain output of any measurable volume of fluid on and
      after postoperative day 3 with an amylase content > 3 times the upper limit of normal serum
      level. Gradual withdrawal of surgically placed drains in patients who are clinically stable
      and tolerate a diet is generally adopted to hasten closure of POPF. For high-output fistulas
      (> 150-200 mL of amylase-rich fluid per day), patients are initially managed with fasting and
      enteral or parenteral nutrition. If fistula output decreases substantially with these
      measures and the patient remains clinically well, drain withdrawal is initiated and oral
      intake is slowly restarted. If the patient remains well despite high fistula output, drains
      are slowly withdrawn in an attempt to decrease the output and close the fistula. When the
      output decrease to less than 10 mL per day, the drains are removed.

      However, the current standard practice of gradual drain withdrawal is time consuming.
      Although clinically stable can be discharged with the drain, the drainage tube often remains
      in place for a prolonged period, with patient discomfort and increased medical cost. In a
      pilot study by the investigators, 32.5% (37/114) of POPF patients required drainage for
      longer than 21 days. Besides, there is also considerable risk of recurrent fluid collection
      along the drain tube tract after drain removal.

      The investigators' experience has shown that trans-drain occlusion of the drain tract
      achieves fistula closure, enabling immediate removal of the drain. In a pilot study, 20
      patients underwent trans-catheter occlusion for POPFs that persisted for more than 3 weeks
      after placement of drainage tubes. No subjective symptoms or abnormalities in blood tests
      were noted in 17 patients after the procedure. Three patients had abdominal pain without
      signs of infection, and the pain spontaneously subsided after conservative treatment. POPF
      healed immediately after occlusion in all of the 20 patients without recurrence during
      follow-up. This multicenter, investigator initiated, prospective, superiority,
      parallel-group, randomized, double-blinded trial aims to compare the efficacy and safety of
      trans-drain occlusion followed by gradual withdrawal of drain versus gradual withdrawal of
      drain alone for POPF that persists for longer than 21 days.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Enrolled patients will be randomly assigned in a 2:1 ratio to receive trans-drain occlusion followed by gradual drain withdrawal or gradual drain withdrawal.
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Days to fistula closure
time frame: The date of fistula closure is the date on which the drain is removed after an output of ≦ 10 mL during 48 hours, without recurrence of fistula within the next 3 months
description: Days from the randomly allocated treatment to fistula closure
measure: 30-day fistula closure rate
time frame: From enrollment to 4 months after fistula occurrence
description: Proportion of patients in whom the drain can be removed by 30 days after occurrence of fistula, without recurrence within the next 3 months
measure: Rate of persistent or recurrent POPF after initial drain removal
time frame: From drain removal to 3 months after drain removal or recurrence of fistula, whichever occurs first
description: Proportion of patients with fluid collection on follow-up CT, which is to be performed at 3 months after removal of drain or when recurrence of fistula is suspected clinically.
measure: Length of hospital stay after the assigned treatment
time frame: From treatment to discharge from the index admission, an average of 2 weeks
description: Days from the assigned treatment to discharge
measure: Hospital costs after the assigned treatment
time frame: From treatment to discharge from the index admission, an average of 2 weeks
description: Costs from the assigned treatment to discharge
measure: Rate of fistula-related complications
time frame: From occurrence of fistula to 3 months after drain removal
description: Proportion of patients who develop fever/infection, ileus, postpancreatectomy hemorrhage from the assigned treatment to end of follow-up.
measure: Incidence of Treatment-Emergent Adverse Events
time frame: From treatment to discharge from the index admission, an average of 2 weeks
description: Fever/infection or pain that develops within 48 hours after the allocated treatment, or any adverse events judged to be related to the treatment
arm group label: Fistulography and trans-drain occlusion
arm group type: Experimental
description: Fistulography is performed to assess the condition of the fistula, and trans-drain occlusion is performed by injecting glue (NBCA and Lipiodol) through the drain to occlude the tract.
arm group label: Fistulography
arm group type: Sham Comparator
description: Fistulography is performed to assess the condition of the fistula, without trains-drain occlusion.
intervention type: Procedure
intervention name: Fistulography and trans-drain occlusion
description: Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube.
Trans-drain occlusion: a 0.035-inch guidewire is inserted via the puncture needle. The drain tube is removed, cut at 4 cm proximal to the skin fixation site, and preserved for reinsertion. After inserting a 40cm 5Fr KMP catheter over the guidewire, the guidewire is removed. Afte rinsing the KMP catheter with 3ml 5% glucose water, withdraw the catheter and simultaneously inject glue (33%, 1:2, 0.5ml of NBCA + 1ml Lipiodol) into the catheter until the proximal 5cm of the catheter remains inside the tract. The guidewire is re-inserted through the catheter, and then the original drain tube is re-inserted over the guidewire. The guidewire is removed and the drain is fixed.
arm group label: Fistulography and trans-drain occlusion
intervention type: Procedure
intervention name: Fistulography
description: Fistulography: an 18G needle is inserted into the tube and diluted contrast medium is slowly injected into the tube.
arm group label: Fistulography
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Yu-Wen Tien, MD, PhD
role: Principal Investigator
affiliation: National Taiwan University Hospital
facility: 
country: Taiwan
citation: Schlitt HJ, Schmidt U, Simunec D, Jager M, Aselmann H, Neipp M, Piso P. Morbidity and mortality associated with pancreatogastrostomy and pancreatojejunostomy following partial pancreatoduodenectomy. Br J Surg. 2002 Oct;89(10):1245-51. doi: 10.1046/j.1365-2168.2002.02202.x.
PMID: 12296891
citation: Balcom JH 4th, Rattner DW, Warshaw AL, Chang Y, Fernandez-del Castillo C. Ten-year experience with 733 pancreatic resections: changing indications, older patients, and decreasing length of hospitalization. Arch Surg. 2001 Apr;136(4):391-8. doi: 10.1001/archsurg.136.4.391.
PMID: 11296108
citation: Yeo CJ, Cameron JL, Sohn TA, Lillemoe KD, Pitt HA, Talamini MA, Hruban RH, Ord SE, Sauter PK, Coleman J, Zahurak ML, Grochow LB, Abrams RA. Six hundred fifty consecutive pancreaticoduodenectomies in the 1990s: pathology, complications, and outcomes. Ann Surg. 1997 Sep;226(3):248-57; discussion 257-60. doi: 10.1097/00000658-199709000-00004.
PMID: 9339931
citation: Bassi C, Marchegiani G, Dervenis C, Sarr M, Abu Hilal M, Adham M, Allen P, Andersson R, Asbun HJ, Besselink MG, Conlon K, Del Chiaro M, Falconi M, Fernandez-Cruz L, Fernandez-Del Castillo C, Fingerhut A, Friess H, Gouma DJ, Hackert T, Izbicki J, Lillemoe KD, Neoptolemos JP, Olah A, Schulick R, Shrikhande SV, Takada T, Takaori K, Traverso W, Vollmer CR, Wolfgang CL, Yeo CJ, Salvia R, Buchler M; International Study Group on Pancreatic Surgery (ISGPS). The 2016 update of the International Study Group (ISGPS) definition and grading of postoperative pancreatic fistula: 11 Years After. Surgery. 2017 Mar;161(3):584-591. doi: 10.1016/j.surg.2016.11.014. Epub 2016 Dec 28.
PMID: 28040257
citation: Bassi C, Dervenis C, Butturini G, Fingerhut A, Yeo C, Izbicki J, Neoptolemos J, Sarr M, Traverso W, Buchler M; International Study Group on Pancreatic Fistula Definition. Postoperative pancreatic fistula: an international study group (ISGPF) definition. Surgery. 2005 Jul;138(1):8-13. doi: 10.1016/j.surg.2005.05.001.
PMID: 16003309
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responsible party type: Sponsor
mesh term: Pancreatic Fistula
mesh term: Fistula
sharing ipd: No
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