<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/NCT01696903</url>
  </required_header>
  <id_info>
    <org_study_id>SKARV-GLH-001</org_study_id>
    <secondary_id>KI-DSGE-DUAS</secondary_id>
    <nct_id>NCT01696903</nct_id>
  </id_info>
  <brief_title>Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy</brief_title>
  <official_title>Clinical Randomized Trial Investigating a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy in Patients With a High Risk for Postoperative Pancreatic Fistula</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital, Linkoeping</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile&#xD;
      system or the duodenum that is associated with a high rate of complications. The study wants&#xD;
      to investigate whether a new technique to reconstruct the joint between the pancreatic gland&#xD;
      and the short bowel can reduce the rate of severe complications after this complex surgical&#xD;
      procedure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pancreaticoduodenectomy is a complex surgical procedure for radically resecting tumors in the&#xD;
      pancreatic head, distal bile duct or duodenum. Postoperative pancreatic fistula is the main&#xD;
      contributor of severe postoperative morbidity after pancreaticoduodenectomy. Characteristics&#xD;
      of the pancreatic gland like soft pancreatic consistency and small pancreatic main duct&#xD;
      predispose for the postoperative fistula development. In high risk patients, the risk of&#xD;
      suffering from associated postoperative morbidity is 50 percent which is considered&#xD;
      unacceptable high. The aim of the current trial is to investigate whether a new anastomosing&#xD;
      technique for the pancreaticojejunostomy can reduce the incidence of associated postoperative&#xD;
      morbidity in patients undergoing pancreaticoduodenectomy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinically Relevant Postoperative Pancreatic Fistula</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 2 weeks</time_frame>
    <description>Postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Associated postoperative morbidity</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 2 weeks</time_frame>
    <description>Postoperative pancreatic fistula and abscesses or fluid collections adjacent to the pancreaticojejunostomy constitute a morbidity event; pancreaticojejunostomy-associated morbidity.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Severity of postoperative complications</measure>
    <time_frame>participants will be followed for the duration of hospital stay, an expected average of 2 weeks</time_frame>
    <description>The severity of postoperative complications as classified by the classification system of postoperative complications adopted for pancreatic surgery.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">123</enrollment>
  <condition>Pancreatic Fistula</condition>
  <arm_group>
    <arm_group_label>Conventional anastomosis</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Conventional anastomosis: The pancreaticojejunostomy is carried out in a traditional way according to &quot;Cattell's duct-to-mucosa technique&quot;.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Novel anastomosis</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Novel anastomosis: This the active comparator to the conventional anastomosis. A new pancreaticojejunostomy technique is used for the reconstruction. The pancreas is intubated into the jejunum.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pancreaticojejunostomy technique</intervention_name>
    <description>The anastomosis between jejunum and remnant pancreas has a pivotal impact on the incidence of postoperative pancreatic fistula. by this novel technique the remnant pancreas is intubated into the jejunum without extensive manipulation.</description>
    <arm_group_label>Novel anastomosis</arm_group_label>
    <other_name>Pancreaticojejunal anastomosis</other_name>
    <other_name>Intubating pancreaticojejunostomy</other_name>
    <other_name>Dunking pancreaticojejunostomy</other_name>
    <other_name>pancreatojejunostomy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled for elective pancreaticoduodenectomy&#xD;
&#xD;
          -  Pancreatic gland with high risk criteria for associated postoperative morbidity&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients do not accept participation&#xD;
&#xD;
          -  Pancreatic gland with intermediate or low risk criteria for associated postoperative&#xD;
             morbidity&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christoph Ansorge, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ralf Segersvärd, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Karolinska Institutet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Upper Abdominal Surgery, Linköping University Hospital</name>
      <address>
        <city>Linköping</city>
        <zip>58185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Surgical gastroenterology, Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <link>
    <url>http://ki.se</url>
    <description>Issuer organization</description>
  </link>
  <link>
    <url>http://www.karolinska.se</url>
    <description>Investigation site</description>
  </link>
  <link>
    <url>http://www.lio.se</url>
    <description>Investigation site</description>
  </link>
  <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>Ansorge C, Strommer L, Andren-Sandberg A, Lundell L, Herrington MK, Segersvard R. Structured intraoperative assessment of pancreatic gland characteristics in predicting complications after pancreaticoduodenectomy. Br J Surg. 2012 Aug;99(8):1076-82. doi: 10.1002/bjs.8784. Epub 2012 May 4.</citation>
    <PMID>22556164</PMID>
  </reference>
  <reference>
    <citation>Kennedy EP, Yeo CJ. Dunking pancreaticojejunostomy versus duct-to-mucosa anastomosis. J Hepatobiliary Pancreat Sci. 2011 Nov;18(6):769-74. doi: 10.1007/s00534-011-0429-y.</citation>
    <PMID>21845376</PMID>
  </reference>
  <verification_date>December 2017</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>September 26, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>December 19, 2017</last_update_submitted>
  <last_update_submitted_qc>December 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Christoph Ansorge</investigator_full_name>
    <investigator_title>Christoph Ansorge, MD, PhD</investigator_title>
  </responsible_party>
  <keyword>Postoperative pancreatic fistula</keyword>
  <keyword>Pancreatic texture</keyword>
  <keyword>Pancreatic duct diameter</keyword>
  <keyword>Pancreatic consistency</keyword>
  <keyword>Pancreaticoduodenectomy</keyword>
  <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>
  <!-- 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/NCT01696903
org study id: SKARV-GLH-001
secondary id: KI-DSGE-DUAS
nct id: NCT01696903
lead sponsor: 
collaborator: 
has dmc: No
Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile
      system or the duodenum that is associated with a high rate of complications. The study wants
      to investigate whether a new technique to reconstruct the joint between the pancreatic gland
      and the short bowel can reduce the rate of severe complications after this complex surgical
      procedure.
Pancreaticoduodenectomy is a complex surgical procedure for radically resecting tumors in the
      pancreatic head, distal bile duct or duodenum. Postoperative pancreatic fistula is the main
      contributor of severe postoperative morbidity after pancreaticoduodenectomy. Characteristics
      of the pancreatic gland like soft pancreatic consistency and small pancreatic main duct
      predispose for the postoperative fistula development. In high risk patients, the risk of
      suffering from associated postoperative morbidity is 50 percent which is considered
      unacceptable high. The aim of the current trial is to investigate whether a new anastomosing
      technique for the pancreaticojejunostomy can reduce the incidence of associated postoperative
      morbidity in patients undergoing pancreaticoduodenectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Clinically Relevant Postoperative Pancreatic Fistula
time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
description: Postoperative pancreatic fistula as defined by the International Study Group of Pancreatic Fistula
measure: Associated postoperative morbidity
time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
description: Postoperative pancreatic fistula and abscesses or fluid collections adjacent to the pancreaticojejunostomy constitute a morbidity event; pancreaticojejunostomy-associated morbidity.
measure: Severity of postoperative complications
time frame: participants will be followed for the duration of hospital stay, an expected average of 2 weeks
description: The severity of postoperative complications as classified by the classification system of postoperative complications adopted for pancreatic surgery.
arm group label: Conventional anastomosis
arm group type: No Intervention
description: Conventional anastomosis: The pancreaticojejunostomy is carried out in a traditional way according to "Cattell's duct-to-mucosa technique".
arm group label: Novel anastomosis
arm group type: Active Comparator
description: Novel anastomosis: This the active comparator to the conventional anastomosis. A new pancreaticojejunostomy technique is used for the reconstruction. The pancreas is intubated into the jejunum.
intervention type: Procedure
intervention name: Pancreaticojejunostomy technique
description: The anastomosis between jejunum and remnant pancreas has a pivotal impact on the incidence of postoperative pancreatic fistula. by this novel technique the remnant pancreas is intubated into the jejunum without extensive manipulation.
arm group label: Novel anastomosis
other name: Pancreaticojejunal anastomosis
other name: Intubating pancreaticojejunostomy
other name: Dunking pancreaticojejunostomy
other name: pancreatojejunostomy
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Christoph Ansorge, MD, PhD
role: Principal Investigator
affiliation: Karolinska Institutet
last name: Ralf Segersvärd, MD, PhD
role: Study Director
affiliation: Karolinska Institutet
facility: 
facility: 
country: Sweden
url: http://ki.se
description: Issuer organization
url: http://www.karolinska.se
description: Investigation site
url: http://www.lio.se
description: Investigation site
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
citation: Ansorge C, Strommer L, Andren-Sandberg A, Lundell L, Herrington MK, Segersvard R. Structured intraoperative assessment of pancreatic gland characteristics in predicting complications after pancreaticoduodenectomy. Br J Surg. 2012 Aug;99(8):1076-82. doi: 10.1002/bjs.8784. Epub 2012 May 4.
PMID: 22556164
citation: Kennedy EP, Yeo CJ. Dunking pancreaticojejunostomy versus duct-to-mucosa anastomosis. J Hepatobiliary Pancreat Sci. 2011 Nov;18(6):769-74. doi: 10.1007/s00534-011-0429-y.
PMID: 21845376
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Christoph Ansorge
investigator title: Christoph Ansorge, MD, PhD
mesh term: Pancreatic Fistula
mesh term: Fistula