Clinical trial NCT04381702: Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy
Official title: Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy: a Single Surgeon Experience
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatoduodenectomy
Keywords: Pancreatoduodenectomy
Benign or malign pathology
Mini-invasive approach
Morbimortality
Laparoscopic approach
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: Université Montpellier
First posted: 2020-05-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who had Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication

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.

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.

Eligibility criteria: Inclusion criteria:

- Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication

Exclusion criteria:

-reject the study protocol

Primary outcomes:
measure: Morbimortality of Laparoscopic pancreaticoduodenectomy (LPD)
timeFrame: 90 postoperative days
Secondary outcomes:
measure: Number of lymph nodes removed
timeFrame: 14 postoperative days
measure: Margins of excision
timeFrame: 14 postoperative days
Other outcomes:
Locations:
Study officials:
affiliation: University Hospital, Montpellier
name: REGIS SOUCHE
role: STUDY_DIRECTOR
References: