Single-centre Propensity Score-matched Comparison Of Laparoscopic Versus Open Pancreatoduodenectomy

Study Overview

Single-centre Propensity Score-matched Comparison of Laparoscopic Versus Open Pancreatoduodenectomy

Minimally invasive pancreatoduodenectomy is increasingly performed. However, technical challenges and a perceived higher risk of complications has hindered wide adoption of a minimally invasive approach. This is a retrospective comparison of a prospectively kept database. The investigators compared surgical outcomes and survival after laparoscopic (LPD) versus open pancreatoduodenectomy (OPD). In order to reduce the effect of bias and confounding, baseline characteristics of both groups were matched using propensity score matching.

All pancreatoduodenectomies were retrieved from a prospectively kept database and retrospectively analysed. All procedures were performed in a single supra-regional Belgian centre. The primary endpoint was the major complication rate, defined by a Clavien-Dindo morbidity classification grade IIIa or higher [11]. Secondary endpoints were 90-day mortality rate, length of hospital stay, operative time, blood loss, transfusion requirements and specific pancreatic complications (pancreatic fistula, haemorrhage, and delayed gastric emptying). In addition, overall survival (OS) and disease-free survival (DFS) were analysed in the subgroups of cancer patients.

Pancreatic Neoplasms

PROCEDURE: pancreatoduodenectomy

B3962020000032

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2021-08-30	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2021-10-26
First Submitted that Met QC Criteria 2021-10-26	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ACTUAL) 2021-11-08
First Posted (ACTUAL) 2021-11-08	Results First Posted N/A	Last Verified 2021-10

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
N/A

Allocation:
N/A

Interventional Model:
N/A

Masking:
N/A

Arms and Interventions

Participant Group/Arm	Intervention/Treatment
: Laparoscopic pancreatoduodenectomy Cohort of patients that underwent a Whipple-procedure through a laparoscopic approach.	PROCEDURE: pancreatoduodenectomy Patients included in the cohorts all underwent pancreatoduodenectomy, open or laparoscopic
: Open pancreatoduodenectomy Cohort of patients that underwent a Whipple-procedure through a traditional open approach.	PROCEDURE: pancreatoduodenectomy Patients included in the cohorts all underwent pancreatoduodenectomy, open or laparoscopic

Participant Group/Arm

Intervention/Treatment

: Laparoscopic pancreatoduodenectomy

Cohort of patients that underwent a Whipple-procedure through a laparoscopic approach.

PROCEDURE: pancreatoduodenectomy

Patients included in the cohorts all underwent pancreatoduodenectomy, open or laparoscopic

: Open pancreatoduodenectomy

Cohort of patients that underwent a Whipple-procedure through a traditional open approach.

PROCEDURE: pancreatoduodenectomy

Patients included in the cohorts all underwent pancreatoduodenectomy, open or laparoscopic

Primary Outcome Measures	Measure Description	Time Frame
Major complication rate	Complications classified as morbidity classification 3a or greater (Clavien-Dindo)	90 days postoperative

Secondary Outcome Measures	Measure Description	Time Frame
Perioperative outcomes	Operative time (min), blood transfusion requirements, estimated blood loss (mL)	Up to 30 days
Short-term postoperative outcomes	Hospital stay (days), drain in situ (days), ICU stay (days)	Up to 30 days
Postoperative morbidity	All complications classified as morbidity classification 3a or greater (Clavien-Dindo)	90 days
Pancreatectomy-specific complications	Postoperative pancreatic fistula, Post-pancreatectomy haemorrhage, delayed gastric emptying, as defined by the respective ISGPS classification	90 days
Overall survival and disease-free survival	The Kaplan-Meier method was used for estimation of survival and compared between subgroups of cancer patients	Up to 20 years
Oncological outcomes	Analysis of resection specimen following contemporary pathlogy guidelines and defined by TNM staging system of pancreatic cancer by AJCC/UICC.	Up to 20 years

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

diagnosis of lesion of pancreatic head or peri-ampullary organs

< 18 years old

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

PRINCIPAL_INVESTIGATOR: Mathieu D'Hondt, MD, 1. Department of Digestive and Hepatobiliary/Pancreatic Surgery AZ Groeninge

Publications

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