PaMIvOP: Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Completed
• CT.gov ID: NCT04381702
• Collaborator: Université Montpellier (Other)
• Enrollment: 90
• Actual Duration (Months): 38

Study Details

Study Description

Brief Summary

Aim of the study :

To determine the morbimortality of Laparoscopic pancreaticoduodenectomy (LPD) compared to the gold standard Open pancreaticoduodenectomy approach (OPD).

Methods :

This is a monocentric retrospective study based on a prospectively maintained clinical database. The study included 28 consecutive patients operated, between January 2016 and March 2019, of Laparoscopic pancreaticoduodenectomy (LPD) that we compared to 62 patients operated with the classical open approach by the same surgeon before the first laparoscopic resection at our institution.

Condition or Disease	Intervention/Treatment	Phase
Pancreatoduodenectomy	Procedure: Pancreatoduodenectomy

Detailed Description

The progress achieved over the last 20 years and the growing experience of visceral surgeons in minimally invasive surgery allow us today to embark on increasingly complex surgeries.

Laparoscopic surgery has even become the gold standard approach for many interventions, whether for bariatric functional surgery, reflux surgery, pelvic static disorder surgery, but also for tumor surgery such as colorectal cancer, esophageal or tail of the pancreas.

However, there are still interventions which, due to their technical difficulty, do not find unanimous consensus among the international scientific community for a possible minimally invasive approach.

The close contact of the pancreatic gland with the splenomesaraic trunk making laparoscopic dissection difficult with risk of uncontrollable bleeding.

It seems, however, that the finesse of the dissection and coagulation instruments and the precision of today's optics make it possible to approach the head of the pancreas in completely satisfactory conditions.

Several centers around the world have developed the LPD technique with encouraging results in terms of perioperative mortality without showing any advantage over laparotomy.

At the Montpellier University Hospital we started performing Laparoscopic pancreaticoduodenectomy (LPD) at the beginning of 2016.

The aim of this study is to assess, on the one hand, the morbimortality and the quality of surgery linked to the development of this relatively new technique in a reference center for pancreatic surgery and on the other hand to assess a possible learning curve effect within our experience.

Study Design

• Study Type: Observational
• Actual Enrollment: 90 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy: a Single Surgeon Experience
• Actual Study Start Date: Aug 1, 2016
• Actual Primary Completion Date: Sep 1, 2019
• Actual Study Completion Date: Oct 1, 2019

Arms and Interventions

Arm	Intervention/Treatment
Patients with an open approach Patients requiring pancreatoduodenectomy and operated with an open approach : All consecutive patients requiring pancreato-duodenectomies for benign or malignant pathology before the first laparoscopic pancreaticoduodenectomy.	Procedure: Pancreatoduodenectomy; Open or laparoscopic pancreato-duodenectomy with pancreatojejunal anastomosis
Patients with a laparoscopic approach Patients requiring pancreatoduodenectomy and operated with a laparoscopic approach : All consecutive patients requiring pancreato-duodenectomies for benign or malignant pathology operated with a laparoscopic approach.	Procedure: Pancreatoduodenectomy; Open or laparoscopic pancreato-duodenectomy with pancreatojejunal anastomosis

Outcome Measures

Primary Outcome Measures

1. Morbimortality of Laparoscopic pancreaticoduodenectomy (LPD) [90 postoperative days]

   Morbimortality of Laparoscopic pancreaticoduodenectomy (LPD) compared to the gold standard Open pancreaticoduodenectomy approach (OPD) :Overall morbidity (according to Clavien Dindo Classification)

Secondary Outcome Measures

1. Number of lymph nodes removed [14 postoperative days]

   Number of lymph nodes removed

2. Margins of excision [14 postoperative days]

   Margins of excision R0, R1, R2

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication

Exclusion criteria:

-reject the study protocol

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University Hospital, Montpellier
• Université Montpellier

Investigators

• Study Director: REGIS SOUCHE, University Hospital, Montpellier

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT04381702
• Other Study ID Numbers: RECHMPL19_0253
• First Posted: May 11, 2020
• Last Update Posted: May 12, 2020
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Montpellier: Pancreatoduodenectomy; Benign or malign pathology; Mini-invasive approach; Morbimortality; Laparoscopic approach

Study Results

No Results Posted as of May 12, 2020