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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
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05110573
Acronym
PSMLOPD
Enrollment
172
Registered
2021-11-08
Start date
2000-01-01
Completion date
2021-03-20
Last updated
2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreatic Neoplasms

Keywords

pancreatoduodenectomy, minimally-invasive surgery, pancreatic cancer, chronic pancreatitis

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.

Interventions

PROCEDUREpancreatoduodenectomy

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

Sponsors

General Hospital Groeninge
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* \< 18 years old

Design outcomes

Primary

MeasureTime frameDescription
Major complication rate90 days postoperativeComplications classified as morbidity classification 3a or greater (Clavien-Dindo)

Secondary

MeasureTime frameDescription
Short-term postoperative outcomesUp to 30 daysHospital stay (days), drain in situ (days), ICU stay (days)
Postoperative morbidity90 daysAll complications classified as morbidity classification 3a or greater (Clavien-Dindo)
Perioperative outcomesUp to 30 daysOperative time (min), blood transfusion requirements, estimated blood loss (mL)
Overall survival and disease-free survivalUp to 20 yearsThe Kaplan-Meier method was used for estimation of survival and compared between subgroups of cancer patients
Oncological outcomesUp to 20 yearsAnalysis of resection specimen following contemporary pathlogy guidelines and defined by TNM staging system of pancreatic cancer by AJCC/UICC.
Pancreatectomy-specific complications90 daysPostoperative pancreatic fistula, Post-pancreatectomy haemorrhage, delayed gastric emptying, as defined by the respective ISGPS classification

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026