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Completed

NCT Number: NCT04381702

Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication

Exclusion criteria

-reject the study protocol

Treatment and study plan

Pancreatoduodenectomy

Procedure

Open or laparoscopic pancreato-duodenectomy with pancreatojejunal anastomosis

Primary outcomes

  1. Morbimortality of Laparoscopic pancreaticoduodenectomy (LPD)

    Time frame: 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 outcomes

  1. Number of lymph nodes removed

    Time frame: 14 postoperative days

    Number of lymph nodes removed

  2. Margins of excision

    Time frame: 14 postoperative days

    Margins of excision R0, R1, R2

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Université Montpellier

Registry information

Official study title

Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy: a Single Surgeon Experience

Acronym: PaMIvOP

Important dates

Study start
2016
Primary completion
2019
Study completion
2019
First posted
May 11, 2020
Registry last updated
May 12, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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