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

Pancreatic Neoplasms Clinical Trial

— PSMLOPD  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05110573
• Other study ID #: B3962020000032
• Status: Completed
• Start date: January 1, 2000
• Est. completion date: March 20, 2021

Study information

• Verified date: October 2021
• Source: General Hospital Groeninge
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: March 20, 2021
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• < 18 years old

Related Conditions & MeSH terms

• Pancreatic Neoplasms

Intervention

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

Locations

Country	Name	City	State
Belgium	General Hospital Groeninge	Kortrijk

Sponsors (1)

Lead Sponsor	Collaborator
General Hospital Groeninge

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Major complication rate	Complications classified as morbidity classification 3a or greater (Clavien-Dindo)	90 days postoperative
Secondary	Perioperative outcomes	Operative time (min), blood transfusion requirements, estimated blood loss (mL)	Up to 30 days
Secondary	Short-term postoperative outcomes	Hospital stay (days), drain in situ (days), ICU stay (days)	Up to 30 days
Secondary	Postoperative morbidity	All complications classified as morbidity classification 3a or greater (Clavien-Dindo)	90 days
Secondary	Pancreatectomy-specific complications	Postoperative pancreatic fistula, Post-pancreatectomy haemorrhage, delayed gastric emptying, as defined by the respective ISGPS classification	90 days
Secondary	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
Secondary	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