Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma

Completed

• Conditions: Distal Cholangiocarcinoma
• Interventions: Procedure: Minimally invasive pancreatoduodenectomy

• Registration Number: NCT05478889
• Lead Sponsor: Fondazione Poliambulanza Istituto Ospedaliero

Brief Summary

Outcomes for minimally invasive and open pancreatoduodenectomy for distal cholangiocarcinoma have not been compared. This is an international multicenter propensity score matched cohort study including patients after MIPD or OPD for dCCA. Primary outcomes included overall survival (OS) and disease-free interval (DFI).

Detailed Description

This study is an international multicenter propensity score matched cohort study using the database of the International Study Group on non-pancreatic periAmpullary CAncer, the ISGACA consortium (www.isgaca.com), including all patients who underwent a pancreatoduodenectomy for non-pancreatic periampullary cancer. Data will be retrospectively collected. To minimize differences between groups, all the participating centers perform both OPD and MIPD and all centers meet the Miami guideline minimum volume of at least 20 MIPD per year. This study is approved by all the locals Ethical Committees (approval number from the promoting center, Comitato etico di Brescia, NP 5318 - 01.06.2022) and it will be performed according to the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE guideline and checklist), and the Declaration of Helsinki.

Study Timeline

• Study Start: 2021-11-01
• Primary Completion: 2022-03-01
• Status Verified: 2022-07
• Study Completion: 2022-07-01
• Study First Submitted: 2022-07-22
• Study First Submitted QC: 2022-07-27
• Last Update Submitted: 2022-07-27
• Study First Posted: 2022-07-28
• Last Update Posted: 2022-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 478

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Minimally invasive pancreatoduodenectomy	Minimally invasive pancreatoduodenectomy	Whipple or pylorus preserving pancreatoduodenectomy following minimally invasive approach (laparoscopic or robotic). Hybrid (hand assisted) precedures will be included in the minimally invasive cohort.

Primary Outcome Measures

Name	Time	Method
Overall survival and disease-free interval	60 months	Time-to-event data, months + occurrence of event (death or recurrence)

Secondary Outcome Measures

Name	Time	Method
Major morbidity	30 days or in-hospital	Clavien-Diendo 3b-5

Trial Locations

Locations (1)

Fondazione Poliambulanza Istituto Ospedaliero; 🇮🇹 Brescia, Italy