NCT04381702

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2016

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2019

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 6, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
Last Updated

May 12, 2020

Status Verified

May 1, 2020

Enrollment Period

3.1 years

First QC Date

May 6, 2020

Last Update Submit

May 10, 2020

Conditions

Pancreatoduodenectomy

Keywords

PancreatoduodenectomyBenign or malign pathologyMini-invasive approachMorbimortalityLaparoscopic approach

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Number of lymph nodes removed

    14 postoperative days

  • Margins of excision

    14 postoperative days

Study Arms (2)

Patients with an open approach

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

Patients with a laparoscopic approach

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

Interventions

PancreatoduodenectomyPROCEDURE

Open or laparoscopic pancreato-duodenectomy with pancreatojejunal anastomosis

Patients with a laparoscopic approachPatients with an open approach

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who had Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication

You may qualify if:

  • \- Pancreatoduodenectomy with pancreatojejunal anastomosis whatever the indication

You may not qualify if:

  • reject the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Pancreaticoduodenectomy

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • REGIS SOUCHE

    University Hospital, Montpellier

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 11, 2020

Study Start

August 1, 2016

Primary Completion

September 1, 2019

Study Completion

October 1, 2019

Last Updated

May 12, 2020

Record last verified: 2020-05