NCT05110573

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2000

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
20.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 20, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 30, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 8, 2021

Completed
Last Updated

November 8, 2021

Status Verified

October 1, 2021

Enrollment Period

20.1 years

First QC Date

August 30, 2021

Last Update Submit

October 26, 2021

Conditions

Pancreatic Neoplasms

Keywords

pancreatoduodenectomyminimally-invasive surgerypancreatic cancerchronic pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Major complication rate

    Complications classified as morbidity classification 3a or greater (Clavien-Dindo)

    90 days postoperative

Secondary Outcomes (6)

  • Perioperative outcomes

    Up to 30 days

  • Short-term postoperative outcomes

    Up to 30 days

  • Postoperative morbidity

    90 days

  • Pancreatectomy-specific complications

    90 days

  • Overall survival and disease-free survival

    Up to 20 years

  • +1 more secondary outcomes

Study Arms (2)

Laparoscopic pancreatoduodenectomy

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

Procedure: pancreatoduodenectomy

Open pancreatoduodenectomy

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

Procedure: pancreatoduodenectomy

Interventions

pancreatoduodenectomyPROCEDURE

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

Laparoscopic pancreatoduodenectomyOpen pancreatoduodenectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

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

You may not qualify if:

  • \< 18 years old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

General Hospital Groeninge

Kortrijk, 8500, Belgium

Location

Related Publications (1)

  • 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.

    PMID: 36624235DERIVED

MeSH Terms

Conditions

Pancreatic NeoplasmsPancreatitis, Chronic

Interventions

Pancreaticoduodenectomy

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System DiseasesPancreatitisChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Mathieu D'Hondt, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. Mathieu D'Hondt, Principal investigator

Study Record Dates

First Submitted

August 30, 2021

First Posted

November 8, 2021

Study Start

January 1, 2000

Primary Completion

January 31, 2020

Study Completion

March 20, 2021

Last Updated

November 8, 2021

Record last verified: 2021-10

Locations

BE(1)