MedDataX Logo

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

NCT ID: NCT05110573

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2000-01-01

Study Completion Date

2021-03-20

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatic Neoplasms

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

pancreatoduodenectomy minimally-invasive surgery pancreatic cancer chronic pancreatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Laparoscopic pancreatoduodenectomy

Cohort of patients that underwent a Whipple-procedure through a laparoscopic approach.

pancreatoduodenectomy

Intervention Type PROCEDURE

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.

pancreatoduodenectomy

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

pancreatoduodenectomy

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

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

Exclusion Criteria

* \< 18 years old
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

General Hospital Groeninge

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dr. M. D'hondt

Dr. Mathieu D'Hondt, Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mathieu D'Hondt, MD

Role: PRINCIPAL_INVESTIGATOR

1. Department of Digestive and Hepatobiliary/Pancreatic Surgery AZ Groeninge

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

General Hospital Groeninge

Kortrijk, , Belgium

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belgium

References

Explore related publications, articles, or registry entries linked to this study.

Vandeputte M, Vansteenkiste F, Ceelen W, De Meyere C, D'Hondt M. Morbidity and survival after laparoscopic versus open pancreatoduodenectomy: propensity score matched comparison. Langenbecks Arch Surg. 2023 Jan 10;408(1):16. doi: 10.1007/s00423-023-02758-y.

Reference Type DERIVED
PMID: 36624235 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

B3962020000032

Identifier Type: -

Identifier Source: org_study_id