Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy (PaMIvOP)

Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy: a Single Surgeon Experience

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.

Study Overview

• Status: Completed
• Conditions: Pancreatoduodenectomy
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 90

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who had Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication

Description

Inclusion criteria:

- Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication

Exclusion criteria:

-reject the study protocol

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Morbimortality of Laparoscopic pancreaticoduodenectomy (LPD)	Morbimortality of Laparoscopic pancreaticoduodenectomy (LPD) compared to the gold standard Open pancreaticoduodenectomy approach (OPD) :Overall morbidity (according to Clavien Dindo Classification)	90 postoperative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of lymph nodes removed	Number of lymph nodes removed	14 postoperative days
Margins of excision	Margins of excision R0, R1, R2	14 postoperative days

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Collaborators: Université Montpellier

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 1, 2016
• Primary Completion (ACTUAL): September 1, 2019
• Study Completion (ACTUAL): October 1, 2019

Study Registration Dates

• First Submitted: May 6, 2020
• First Submitted That Met QC Criteria: May 6, 2020
• First Posted (ACTUAL): May 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): May 12, 2020
• Last Update Submitted That Met QC Criteria: May 10, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Pancreatoduodenectomy; Mini-invasive approach; Benign or malign pathology; Morbimortality; Laparoscopic approach
• Other Study ID Numbers: RECHMPL19_0253

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No