Trials / Completed
CompletedNCT05110573
Single-centre Propensity Score-matched Comparison of Laparoscopic Versus Open Pancreatoduodenectomy
Morbidity and Survival After Minimally Invasive Versus Open Pancreatoduodenectomy: Propensity Score Matched Comparison
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 172 (actual)
- Sponsor
- General Hospital Groeninge · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | pancreatoduodenectomy | Patients included in the cohorts all underwent pancreatoduodenectomy, open or laparoscopic |
Timeline
- Start date
- 2000-01-01
- Primary completion
- 2020-01-31
- Completion
- 2021-03-20
- First posted
- 2021-11-08
- Last updated
- 2021-11-08
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT05110573. Inclusion in this directory is not an endorsement.