Clincosm LogoSign in Get a demo

PaNECK: Neck Division Level and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy

Sponsor
University Hospital, Montpellier (Other)
Overall Status
Completed
CT.gov ID
NCT03850236
Collaborator
(none)
196
Enrollment
1
Location
124.9
Actual Duration (Months)
1.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Brief Summary:*

Aim of the study :

To evaluate if the neck division level significantly influences the postoperative pancreatic fistula rate of pancreatico-jejunal anastomosis after pancreatoduodenectomy.

Methods :

Patients who underwent oncologic or non-oncologic pancreatoduodenectomy between 01 January 2009 and 04 April 2018 will be included in this retrospective analysis. Two independent radiologists will measure the distance between the left side of the portal vein and the remnant pancreatic stump on post operative CT scan, blindly for postoperative course. This new variable will be integrated in a logistic regression model in addition to well known risk factors of POPF.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The pancreatic neck is an anatomical area mainly vascularized by the arterial network derived from the gastroduodenal artery and branches of the superior mesenteric artery running in the pancreatic head.

    The neck arterial blood supply is probably reduced after pancreatoduodenectomy due to the ligation of gastroduodenal artery and collaterals of superior mesenteric artery.

    Postoperative pancreatic fistula (POPF) is the main complication after pancreatoduodenectomy. POPF has an estimated rate of 15 to 30%. So, this complication is frequent and could be lethal. Several studies have been driven to identify risks factors of POPF but there are no actual data on the impact of the neck division level and neck vascularization on POPF.

    By considering the level of neck division is variable, the investigator hypothesize that a long remnant neck, is a risk factor of POPF after pancreatoduodenectomy with pancreatojejunal anastomosis.

    The aim of the present study is to integrate this new variable in a logistic regression model in addition to well known risk factors of POPF.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    196 participants
    Observational Model:
    Cohort
    Time Perspective:
    Retrospective
    Official Title:
    Impact of the Neck Division Level During Pancreaticoduodenectomy on Postoperative Pancreatic Fistula?
    Actual Study Start Date :
    Jan 1, 2009
    Actual Primary Completion Date :
    Apr 1, 2018
    Actual Study Completion Date :
    Jun 1, 2019

    Outcome Measures

    Primary Outcome Measures

    1. grade of fistula [90 postoperative days]

      fistula grade B / C pancreatico-jejunal anastomosis after cephalic duodeno-pancreatectomy

    Secondary Outcome Measures

    1. Overall morbidity [90 postoperative days]

      Overall morbidity (according to Clavien Dindo Classification)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion criteria:

    • Elective Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication

    • age > 18 y.o.

    Exclusion criteria:

    • past history of pancreatic surgery

    • patient who reject the study protocol

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Uhmontpellier Montpellier France 34295

    Sponsors and Collaborators

    • University Hospital, Montpellier

    Investigators

    • Study Director: REGIS SOUCHE, University Hospital, Montpellier

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University Hospital, Montpellier
    ClinicalTrials.gov Identifier:
    NCT03850236
    Other Study ID Numbers:
    • RECHMPL19_0025
    First Posted:
    Feb 21, 2019
    Last Update Posted:
    Nov 19, 2019
    Last Verified:
    Nov 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University Hospital, Montpellier
    pancreatic fistula
    morbidity
    risk factors
    Benign or malign pathology
    Additional relevant MeSH terms:
    Pancreatic Fistula
    Fistula

    Study Results

    No Results Posted as of Nov 19, 2019