Clinical trial NCT03850236: Neck Division Level and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy
Official title: Impact of the Neck Division Level During Pancreaticoduodenectomy on Postoperative Pancreatic Fistula?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatoduodenectomy
Keywords: pancreatic fistula
morbidity
risk factors
Benign or malign pathology
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2019-02-21
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients requiring pancreatoduodenectomy for benign or malignant pathology.

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.

Eligibility criteria: 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

Primary outcomes:
measure: grade of fistula
timeFrame: 90 postoperative days
Secondary outcomes:
measure: Overall morbidity
timeFrame: 90 postoperative days
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: REGIS SOUCHE
role: STUDY_DIRECTOR
References:
citation: 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.