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CompletedNCT03850236PaNECKUpdated Nov 19, 2019

Neck Division Level and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy

An observational study in Pancreatoduodenectomy, sponsored by University Hospital, Montpellier. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-19.

Sponsored by University Hospital, Montpellier · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
196
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Pancreatoduodenectomy

Keywords

  • pancreatic fistula
  • morbidity
  • risk factors
  • Benign or malign pathology
03

In context

Pancreatic Fistula

125 studies on the registry are indexed under Pancreatic Fistula; 27 are open to participants now.

This study's enrollment of 196 is above the median of 173 across 49 observational studies indexed under Pancreatic Fistula.

Browse Pancreatic Fistula studies →

Lead sponsor

University Hospital, Montpellier is the lead sponsor of 1,244 studies on the registry; 225 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients requiring pancreatoduodenectomy for benign or malignant pathology.

Inclusion criteria

  • Elective Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication
  • age > 18 y.o.

Exclusion criteria

Exclusion criteria:

  • past history of pancreatic surgery
  • patient who reject the study protocol
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
196 participants (actual)
Patient registry
No
Biospecimen retention
None retained
06

What researchers measure

Primary outcomes

  1. grade of fistula

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

    Time frame: 90 postoperative days

Secondary outcomes

  1. Overall morbidity

    Overall morbidity (according to Clavien Dindo Classification)

    Time frame: 90 postoperative days

07

Study locations

1 site
  • Uhmontpellier
    Montpellier, 34295, France
08

References and documents

Publications

  • Bardol T, Delicque J, Hermida M, Herrero A, Guiu B, Fabre JM, Souche R. Neck transection level and postoperative pancreatic fistula after pancreaticoduodenectomy: A retrospective cohort study of 195 patients. Int J Surg. 2020 Oct;82:43-50. doi: 10.1016/j.ijsu.2020.08.001. Epub 2020 Aug 22. PubMed 32841726 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03850236
Lead sponsor
University Hospital, Montpellier
Responsible party
Sponsor
First posted
Feb 21, 2019
Start date
Jan 1, 2009
Primary completion
Apr 1, 2018
Completion
Jun 1, 2019
Last update
Nov 19, 2019

Study contacts

REGIS SOUCHE
study director · University Hospital, Montpellier

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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