Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy

Pancreatoduodenectomy Clinical Trial

— PaMIvOP  

Official title:

Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy: a Single Surgeon Experience

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04381702
• Other study ID #: RECHMPL19_0253
• Status: Completed
• Start date: August 1, 2016
• Est. completion date: October 1, 2019

Study information

• Verified date: May 2020
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: October 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion criteria:

• Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication

Exclusion criteria:

-reject the study protocol

Related Conditions & MeSH terms

• Pancreatoduodenectomy

Intervention

Procedure:
• Pancreatoduodenectomy
Open or laparoscopic pancreato-duodenectomy with pancreatojejunal anastomosis

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Department of Anesthesia and Critical Care, Université de Montpellier- Nîmes, Montpellier, France, Department of Digestive Surgery and Transplantation, Université de Montpellier- Nîmes, Montpellier, France, Department of Medical Oncology, Université de Montpellier- Nîmes, Montpellier, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of lymph nodes removed	Number of lymph nodes removed	14 postoperative days
Secondary	Margins of excision	Margins of excision R0, R1, R2	14 postoperative days