Clinical trial NCT05110573: Single-centre Propensity Score-matched Comparison of Laparoscopic Versus Open Pancreatoduodenectomy
Official title: Morbidity and Survival After Minimally Invasive Versus Open Pancreatoduodenectomy: Propensity Score Matched Comparison
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pancreatic Neoplasms
Keywords: pancreatoduodenectomy
minimally-invasive surgery
pancreatic cancer
chronic pancreatitis
Lead sponsor: General Hospital Groeninge
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Indications for surgery were benign or malignant lesions of the pancreatic head or peri-ampullary organs. All patients of ≥18 years old diagnosed with suspicious lesions located in the pancreas, ampulla, duodenum or distal bile duct were presented at the multidisciplinary oncological team. In case of biopsy-proven malignancy or clinical and radiological suspicion without confirmed malignancy, surgical resection was considered in accordance with contemporary guidelines

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* \< 18 years old

Primary outcomes:
measure: Major complication rate
timeFrame: 90 days postoperative
Secondary outcomes:
measure: Perioperative outcomes
timeFrame: Up to 30 days
measure: Short-term postoperative outcomes
timeFrame: Up to 30 days
measure: Postoperative morbidity
timeFrame: 90 days
measure: Pancreatectomy-specific complications
timeFrame: 90 days
measure: Overall survival and disease-free survival
timeFrame: Up to 20 years
measure: Oncological outcomes
timeFrame: Up to 20 years
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
facility: General Hospital Groeninge
Study officials:
affiliation: 1. Department of Digestive and Hepatobiliary/Pancreatic Surgery AZ Groeninge
name: Mathieu D'Hondt, MD
role: PRINCIPAL_INVESTIGATOR
References: