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Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy (PaMIvOP)

University Hospital Center (CHU) logo

University Hospital Center (CHU)

Status

Completed

Conditions

Pancreatoduodenectomy

Treatments

Procedure: Pancreatoduodenectomy

Study type

Observational

Funder types

Other

Identifiers

NCT04381702
RECHMPL19_0253

Details and patient eligibility

About

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.

Full 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.

Enrollment

90 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication

Exclusion criteria

-reject the study protocol

Trial design

90 participants in 2 patient groups

Patients with an open approach
Description:
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.
Treatment:
Procedure: Pancreatoduodenectomy
Patients with a laparoscopic approach
Description:
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.
Treatment:
Procedure: Pancreatoduodenectomy

Trial contacts and locations

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Data sourced from clinicaltrials.gov

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