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Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy

Outcome After Laparoscopic Versus Open Pancreaticoduodenectomy: a Single Surgeon Experience

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04381702
Acronym
PaMIvOP
Enrollment
90
Registered
2020-05-11
Start date
2016-08-01
Completion date
2019-10-01
Last updated
2020-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatoduodenectomy

Keywords

Pancreatoduodenectomy, Benign or malign pathology, Mini-invasive approach, Morbimortality, Laparoscopic approach

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.

Interventions

PROCEDUREPancreatoduodenectomy

Open or laparoscopic pancreato-duodenectomy with pancreatojejunal anastomosis

Sponsors

Université Montpellier
CollaboratorOTHER
University Hospital, Montpellier
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

\- Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication

Exclusion criteria

-reject the study protocol

Design outcomes

Primary

MeasureTime frameDescription
Morbimortality of Laparoscopic pancreaticoduodenectomy (LPD)90 postoperative daysMorbimortality of Laparoscopic pancreaticoduodenectomy (LPD) compared to the gold standard Open pancreaticoduodenectomy approach (OPD) :Overall morbidity (according to Clavien Dindo Classification)

Secondary

MeasureTime frameDescription
Number of lymph nodes removed14 postoperative daysNumber of lymph nodes removed
Margins of excision14 postoperative daysMargins of excision R0, R1, R2

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026