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

Completed

• Conditions: Pancreatic Neoplasms
• Interventions: Procedure: pancreatoduodenectomy

• Registration Number: NCT05110573
• Lead Sponsor: General Hospital Groeninge

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2000-01-01
• Primary Completion: 2020-01-31
• Study Completion: 2021-03-20
• Study First Submitted: 2021-08-30
• Status Verified: 2021-10
• Study First Submitted QC: 2021-10-26
• Last Update Submitted: 2021-10-26
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

Inclusion Criteria

• diagnosis of lesion of pancreatic head or peri-ampullary organs

Exclusion Criteria

• < 18 years old

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Laparoscopic pancreatoduodenectomy	pancreatoduodenectomy	Cohort of patients that underwent a Whipple-procedure through a laparoscopic approach.
Open pancreatoduodenectomy	pancreatoduodenectomy	Cohort of patients that underwent a Whipple-procedure through a traditional open approach.

Primary Outcome Measures

Name	Time	Method
Major complication rate	90 days postoperative	Complications classified as morbidity classification 3a or greater (Clavien-Dindo)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

General Hospital Groeninge; 🇧🇪 Kortrijk, Belgium