Neck Division Level and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy

NCT ID: NCT03850236

Last Updated: 2019-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

196 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-01

Study Completion Date

2019-06-01

Brief Summary

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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

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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.

Conditions

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Pancreatoduodenectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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REGIS SOUCHE

Role: STUDY_DIRECTOR

University Hospital, Montpellier

Locations

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Uhmontpellier

Montpellier, , France

Site Status

Countries

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France

References

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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.

Reference Type DERIVED
PMID: 32841726 (View on PubMed)

Other Identifiers

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RECHMPL19_0025

Identifier Type: -

Identifier Source: org_study_id

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