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

Morbidity and Survival After Minimally Invasive Versus Open Pancreatoduodenectomy: Propensity Score Matched Comparison

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.

Study Overview

• Status: Completed
• Conditions: Pancreatic Neoplasms
• Intervention / Treatment: Procedure: pancreatoduodenectomy

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 Type: Observational
• Enrollment (Actual): 172

Contacts and Locations

Study Locations

• Belgium
  • Kortrijk, Belgium, 8500
    • General Hospital Groeninge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

Inclusion Criteria:

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

Exclusion Criteria:

• < 18 years old

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Laparoscopic pancreatoduodenectomy; Cohort of patients that underwent a Whipple-procedure through a laparoscopic approach.	Procedure: pancreatoduodenectomy; Patients included in the cohorts all underwent pancreatoduodenectomy, open or laparoscopic
Open pancreatoduodenectomy; Cohort of patients that underwent a Whipple-procedure through a traditional open approach.	Procedure: pancreatoduodenectomy; Patients included in the cohorts all underwent pancreatoduodenectomy, open or laparoscopic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Major complication rate	Complications classified as morbidity classification 3a or greater (Clavien-Dindo)	90 days postoperative

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: General Hospital Groeninge
• Investigators: Principal Investigator: Mathieu D'Hondt, MD, 1. Department of Digestive and Hepatobiliary/Pancreatic Surgery AZ Groeninge

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2000
• Primary Completion (Actual): January 31, 2020
• Study Completion (Actual): March 20, 2021

Study Registration Dates

• First Submitted: August 30, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 8, 2021

Study Record Updates

• Last Update Posted (Actual): November 8, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: pancreatic cancer; chronic pancreatitis; pancreatoduodenectomy; minimally-invasive surgery
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pancreatic Diseases; Pancreatic Neoplasms
• Other Study ID Numbers: B3962020000032

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No