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

G

General Hospital Groeninge

Status

Completed

Conditions

Pancreatic Neoplasms

Treatments

Procedure: pancreatoduodenectomy

Study type

Observational

Funder types

Other

Identifiers

NCT05110573
B3962020000032

Details and patient eligibility

About

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.

Full 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.

Enrollment

172 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

  • < 18 years old

Trial design

172 participants in 2 patient groups

Laparoscopic pancreatoduodenectomy
Description:
Cohort of patients that underwent a Whipple-procedure through a laparoscopic approach.
Treatment:
Procedure: pancreatoduodenectomy
Open pancreatoduodenectomy
Description:
Cohort of patients that underwent a Whipple-procedure through a traditional open approach.
Treatment:
Procedure: pancreatoduodenectomy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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