Neck Division Level and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy

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.

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Key information

Conditions

Pancreatoduodenectomy Digestive System Diseases Digestive System Fistula Fistula Pancreatic Diseases Pancreatic Fistula Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Uhmontpellier

Montpellier, 34295, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

grade of fistula

Time frame: 90 postoperative days

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

Secondary outcomes

Overall morbidity

Time frame: 90 postoperative days

Overall morbidity (according to Clavien Dindo Classification)

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Official study title

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

Acronym: PaNECK

Important dates

Study start: 2009
Primary completion: 2018
Study completion: 2019
First posted: Feb 21, 2019
Registry last updated: Nov 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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