<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/NCT03277625</url>
  </required_header>
  <id_info>
    <org_study_id>16-5706</org_study_id>
    <nct_id>NCT03277625</nct_id>
  </id_info>
  <brief_title>Modified Reconstruction for Pancreatic Head Resection</brief_title>
  <official_title>Safety and Efficacy of Modified Single-loop Omega-shaped Reconstruction After Pancreaticoduodenectomy in Patients With High-risk Pancreas</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Josef Hospital Bochum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Josef Hospital Bochum</source>
  <oversight_info>
    <has_dmc>Yes</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 observational study aims to prove the safety and efficacy of a modified method of&#xD;
      reconstruction after pancreatic head resection utilizing a single Omega shaped intestinal&#xD;
      Loop with an additional anastomosis between the pancreatic and biliary anstomoses. This&#xD;
      simple and fast method is expected to provide the advantages of a double-loop reconstruction&#xD;
      without adding time and difficulty to the reconstruction process during&#xD;
      pancreaticoduodenectomy. The additional intestinal anastomosis should allow Diversion of&#xD;
      pancreatic Juice from bile thus reducing the severity of possible postoperative pancreatic&#xD;
      Fistula, especially in the subgroup of patients undergoing a pancreaticoduodenectomy and&#xD;
      having a high-risk pancreatic remnant, i.e. very soft, fragile and fatty pancreas with a&#xD;
      tiny, non-dilated pancreatic main duct. The Primary Point of the study ist the severity of&#xD;
      postoperative pancreatic Fistula, as well as the total rate of severe postoperative&#xD;
      complications, defined as Grade 3b or more according to the classification of Dindo-Clavien.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Postoperative pancreatic fistula (POPF) is the most common and specific complication of&#xD;
      pancreaticoduodenectomy (PD) with reported rates of over 20% even at high-volume centers.&#xD;
      POPF may cause life-threatening secondary complications such as postpancreatectomy hemorrhage&#xD;
      (PPH), intraabdominal abscess, and sepsis, leading to increased costs, prolonged hospital&#xD;
      stay as well as to delayed chemotherapy in oncologic patients.&#xD;
&#xD;
      A myriad of innovations in surgical technique has been introduced over the last several&#xD;
      decades in order to reduce the rate and severity of POPF. One of these includes the&#xD;
      double-loop (DL) reconstruction with isolated Roux-en-Y loops for the pancreatic and biliary&#xD;
      anastomoses. It was first described in 1976 by Machado and has afterwards been applied by&#xD;
      many surgeons in different variations. The method is based on the empirical hypothesis that&#xD;
      diverting bile away from pancreatic juice may prevent their mutual activation and thus&#xD;
      decrease their aggressiveness and detrimental effect on the pancreaticojejunostomy (PJ).&#xD;
      Theoretically, reduction in the rate and severity of POPF should be expected. Some randomized&#xD;
      controlled trials (RCT) reported decreased severity of POPF and lower rates of associated&#xD;
      morbidity, whereas others failed to confirm these positive results. A substantially prolonged&#xD;
      duration of surgery was observed in most of the studies.&#xD;
&#xD;
      In order to reduce the rate and severity of POPF without prolonging duration of surgery, we&#xD;
      introduced in 2015 a new method of reconstruction during PD using a single long intestinal&#xD;
      loop with a side-to-side anastomosis between the afferent and efferent limbs of the&#xD;
      hepaticojejunostomy (HJ) similar to a Braun anastomosis in a Billroth II resection. It aimed&#xD;
      at increasing the distance between the pancreatic and biliary anastomotic sites and&#xD;
      facilitating isolated flow of bile and pancreatic secretions in a simple, fast and&#xD;
      straightforward manner without the need for a time-consuming and sometimes technically&#xD;
      challenging DL reconstruction.&#xD;
&#xD;
      This study aims to reveal how the new modified single-loop (mSL) method of reconstruction&#xD;
      compares to the conventional single loop (SL) and DL methods in terms of severity and rate of&#xD;
      POPF as well as associated major complications after PD in high-risk patients with a soft&#xD;
      pancreatic remnant and a small pancreatic duct.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2015</start_date>
  <completion_date type="Anticipated">June 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Severity of postoperative pancreatic fistula</measure>
    <time_frame>from postoperative day 3 until postoperative day 30</time_frame>
    <description>grade B and grade C Fistula as clinically relevant</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Major postoperative complications</measure>
    <time_frame>postoperative days 1 to 30</time_frame>
    <description>all type of postoperative complications grades 3b, 4 and 5 (mortality) after Dindo-Clavien</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pancreaticoduodenal; Fistula</condition>
  <arm_group>
    <arm_group_label>pancreaticoduodenectomy</arm_group_label>
    <description>patients undergoing pancreticoduodenectomy and having a soft, fragile and/or fatty pancreatic remnant, combined with small pancreatic duct having a Diameter &lt;3 mm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>modified omega-shaped single-loop</intervention_name>
    <description>A double-layer, end-to-side, duct-to-mucosa PJ using interrupted polydioxanone 5-0 suture (PDS II, Ethicon, Somerville, USA) for the outer layer and interrupted polypropylene 5-0 suture (Prolene, Ethicon, USA) for the inner layer is the standard technique during PD at our Institution. For the modified omega-shaped single-Loop reconstruction the loop between PJ and HJ is left intentionally longer at about 25-30 cm and an additional side-to-side jejunojejunal anastomosis is performed at the lowest point between the afferent and efferent loops of the HJ This intestinal anastomosis is done in a double-layer continuous PDS 5-0 suture technique. Neither sealants, nor stents are being applied at the PJ. In cases of thin walled and tiny hepatic ducts, the HJ is splinted using an externally diverted T-tube.</description>
    <arm_group_label>pancreaticoduodenectomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all patients undergoing elective and emergency pancreaticoduodenectomy irrespective of&#xD;
        diagnosis. the typical Patient is an obese, old, has a small pancreatic lesion, either&#xD;
        cystic or solid, not leading to obstruction of the pancreatic duct or the biliary duct.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pancreaticoduodenectomy&#xD;
&#xD;
          -  soft, fragile or fatty pancreatic remnant combined with pancreatic duct &lt;3mm&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  soft pancreas, but large pancreatic duct&gt;3mm&#xD;
&#xD;
          -  small pancreatic duct &lt;3mm, but hard pancreatic remnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>98 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Orlin Belyaev, MD, PhD</last_name>
    <phone>00492345092212</phone>
    <email>orlin.belyaev@gmx.de</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Ilgar Aghalarov</last_name>
    <phone>00492345090</phone>
    <email>i.aghalarov@klinikum-bochum.de</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Department of Surgery, St. Josef Hospital, Ruhr University of Bochum</name>
      <address>
        <city>Bochum</city>
        <state>NRW</state>
        <zip>44791</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Orlin Belyaev, MD</last_name>
      <phone>+49 234 509 0</phone>
      <email>o.belyaev@klinikum-bochum.de</email>
    </contact>
    <contact_backup>
      <last_name>Waldemar Uhl, MD, PhD</last_name>
      <phone>+49 234 509 2211</phone>
      <email>w.uhl@klinikum-bochum.de</email>
    </contact_backup>
    <investigator>
      <last_name>Ilgar Aghalarov</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Orlin Belyaev, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Waldemar Uhl, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <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 11, 2017</study_first_posted>
  <last_update_submitted>September 7, 2017</last_update_submitted>
  <last_update_submitted_qc>September 7, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Josef Hospital Bochum</investigator_affiliation>
    <investigator_full_name>Orlin Belyaev</investigator_full_name>
    <investigator_title>PD Dr. med.</investigator_title>
  </responsible_party>
  <keyword>pancreaticoduodenectomy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03277625
org study id: 16-5706
nct id: NCT03277625
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This observational study aims to prove the safety and efficacy of a modified method of
      reconstruction after pancreatic head resection utilizing a single Omega shaped intestinal
      Loop with an additional anastomosis between the pancreatic and biliary anstomoses. This
      simple and fast method is expected to provide the advantages of a double-loop reconstruction
      without adding time and difficulty to the reconstruction process during
      pancreaticoduodenectomy. The additional intestinal anastomosis should allow Diversion of
      pancreatic Juice from bile thus reducing the severity of possible postoperative pancreatic
      Fistula, especially in the subgroup of patients undergoing a pancreaticoduodenectomy and
      having a high-risk pancreatic remnant, i.e. very soft, fragile and fatty pancreas with a
      tiny, non-dilated pancreatic main duct. The Primary Point of the study ist the severity of
      postoperative pancreatic Fistula, as well as the total rate of severe postoperative
      complications, defined as Grade 3b or more according to the classification of Dindo-Clavien.
Postoperative pancreatic fistula (POPF) is the most common and specific complication of
      pancreaticoduodenectomy (PD) with reported rates of over 20% even at high-volume centers.
      POPF may cause life-threatening secondary complications such as postpancreatectomy hemorrhage
      (PPH), intraabdominal abscess, and sepsis, leading to increased costs, prolonged hospital
      stay as well as to delayed chemotherapy in oncologic patients.

      A myriad of innovations in surgical technique has been introduced over the last several
      decades in order to reduce the rate and severity of POPF. One of these includes the
      double-loop (DL) reconstruction with isolated Roux-en-Y loops for the pancreatic and biliary
      anastomoses. It was first described in 1976 by Machado and has afterwards been applied by
      many surgeons in different variations. The method is based on the empirical hypothesis that
      diverting bile away from pancreatic juice may prevent their mutual activation and thus
      decrease their aggressiveness and detrimental effect on the pancreaticojejunostomy (PJ).
      Theoretically, reduction in the rate and severity of POPF should be expected. Some randomized
      controlled trials (RCT) reported decreased severity of POPF and lower rates of associated
      morbidity, whereas others failed to confirm these positive results. A substantially prolonged
      duration of surgery was observed in most of the studies.

      In order to reduce the rate and severity of POPF without prolonging duration of surgery, we
      introduced in 2015 a new method of reconstruction during PD using a single long intestinal
      loop with a side-to-side anastomosis between the afferent and efferent limbs of the
      hepaticojejunostomy (HJ) similar to a Braun anastomosis in a Billroth II resection. It aimed
      at increasing the distance between the pancreatic and biliary anastomotic sites and
      facilitating isolated flow of bile and pancreatic secretions in a simple, fast and
      straightforward manner without the need for a time-consuming and sometimes technically
      challenging DL reconstruction.

      This study aims to reveal how the new modified single-loop (mSL) method of reconstruction
      compares to the conventional single loop (SL) and DL methods in terms of severity and rate of
      POPF as well as associated major complications after PD in high-risk patients with a soft
      pancreatic remnant and a small pancreatic duct.
observational model: Case-Only
time perspective: Prospective
measure: Severity of postoperative pancreatic fistula
time frame: from postoperative day 3 until postoperative day 30
description: grade B and grade C Fistula as clinically relevant
measure: Major postoperative complications
time frame: postoperative days 1 to 30
description: all type of postoperative complications grades 3b, 4 and 5 (mortality) after Dindo-Clavien
arm group label: pancreaticoduodenectomy
description: patients undergoing pancreticoduodenectomy and having a soft, fragile and/or fatty pancreatic remnant, combined with small pancreatic duct having a Diameter <3 mm.
intervention type: Procedure
intervention name: modified omega-shaped single-loop
description: A double-layer, end-to-side, duct-to-mucosa PJ using interrupted polydioxanone 5-0 suture (PDS II, Ethicon, Somerville, USA) for the outer layer and interrupted polypropylene 5-0 suture (Prolene, Ethicon, USA) for the inner layer is the standard technique during PD at our Institution. For the modified omega-shaped single-Loop reconstruction the loop between PJ and HJ is left intentionally longer at about 25-30 cm and an additional side-to-side jejunojejunal anastomosis is performed at the lowest point between the afferent and efferent loops of the HJ This intestinal anastomosis is done in a double-layer continuous PDS 5-0 suture technique. Neither sealants, nor stents are being applied at the PJ. In cases of thin walled and tiny hepatic ducts, the HJ is splinted using an externally diverted T-tube.
arm group label: pancreaticoduodenectomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 98 Years
healthy volunteers: No
last name: Orlin Belyaev, MD, PhD
phone: 00492345092212
email: orlin.belyaev@gmx.de
last name: Ilgar Aghalarov
phone: 00492345090
email: i.aghalarov@klinikum-bochum.de
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
investigator: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: St. Josef Hospital Bochum
investigator full name: Orlin Belyaev
investigator title: PD Dr. med.
mesh term: Fistula
sharing ipd: No