Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy: a Single Surgeon Experience

Conditions
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Pancreatoduodenectomy

Intervention / Treatment
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* Procedure: Pancreatoduodenectomy


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: - Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication Exclusion criteria: -reject the study protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with an open approach<br>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<br>* Open or laparoscopic pancreato-duodenectomy with pancreatojejunal anastomosis<br>|
| Patients with a laparoscopic approach<br>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<br>* Open or laparoscopic pancreato-duodenectomy with pancreatojejunal anastomosis<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pancreatoduodenectomy, Benign or malign pathology, Mini-invasive approach, Morbimortality, Laparoscopic approach