Neck Division Level and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy

Pancreatoduodenectomy Clinical Trial

— PaNECK  

Official title:

Impact of the Neck Division Level During Pancreaticoduodenectomy on Postoperative Pancreatic Fistula?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03850236
• Other study ID #: RECHMPL19_0025
• Status: Completed
• Start date: January 1, 2009
• Est. completion date: June 1, 2019

Study information

• Verified date: November 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: June 1, 2019
• Est. primary completion date: April 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fistula
• Pancreatic Fistula
• Pancreatoduodenectomy

Locations

Country	Name	City	State
France	Uhmontpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	grade of fistula	fistula grade B / C pancreatico-jejunal anastomosis after cephalic duodeno-pancreatectomy	90 postoperative days
Secondary	Overall morbidity	Overall morbidity (according to Clavien Dindo Classification)	90 postoperative days