Neck Division Level and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy

Completed

• Conditions: Pancreatoduodenectomy

• Registration Number: NCT03850236
• Lead Sponsor: University Hospital, Montpellier

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.

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 Timeline

• Study Start: 2009-01-01
• Primary Completion: 2018-04-01
• Study First Submitted: 2019-02-18
• Study First Submitted QC: 2019-02-20
• Study First Posted: 2019-02-21
• Study Completion: 2019-06-01
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-18
• Last Update Posted: 2019-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
grade of fistula	90 postoperative days	fistula grade B / C pancreatico-jejunal anastomosis after cephalic duodeno-pancreatectomy

Secondary Outcome Measures

Name	Time	Method
Overall morbidity	90 postoperative days	Overall morbidity (according to Clavien Dindo Classification)

Trial Locations

Locations (1)

Uhmontpellier; 🇫🇷 Montpellier, France