Neck Division Level and Postoperative Pancreatic Fistula After Pancreaticoduodenectomy

NCT03850236 | Completed

• 1 other identifier: RECHMPL19_0025
• Study Type: observational
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatoduodenectomy

Keywords

pancreatic fistula; morbidity; risk factors; Benign or malign pathology

Outcome Measures

Primary Outcomes (1)

• grade of fistula

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

  90 postoperative days

Secondary Outcomes (1)

• Overall morbidity

  90 postoperative days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring pancreatoduodenectomy for benign or malignant pathology.

You may qualify if:

• Elective Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication
• age \> 18 y.o.

You may not qualify if:

• past history of pancreatic surgery
• patient who reject the study protocol

Sponsors & Collaborators

• University Hospital, Montpellier: lead

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

Related Publications (1)

• 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.

  PMID: 32841726 DERIVED

Biospecimen

Retention: NONE RETAINED

Cytolyt Samples: Liquid conservation samples from patients who underwent endoscopic ultrasound with fine needle aspiration/biopsy for suspicious pancreatic mass at the CHU de Montpellier were conserved at +4°c. Cytolyt samples do not contain any cell or tissue from patient, this liquid is systematically trashed in current practice. No genetics analysis will be performed from these particular samples in the present study.

MeSH Terms

Conditions

Pancreatic Fistula

Condition Hierarchy (Ancestors)

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

Study Officials

• REGIS SOUCHE

  University Hospital, Montpellier

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: February 21, 2019
• Study Start: January 1, 2009
• Primary Completion: April 1, 2018
• Study Completion: June 1, 2019
• Last Updated: November 19, 2019

Record last verified: 2019-11

Locations

FR (1)