NCT05478889

Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma

Surgical and Oncological Outcome After Minimally Invasive and Open Pancreatoduodenectomy for Distal Cholangiocarcinoma: an International Propensity Score Cohort Study

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 478 (actual)
• Sponsor: Fondazione Poliambulanza Istituto Ospedaliero · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Distal Cholangiocarcinoma

Interventions

Type	Name	Description
PROCEDURE	Minimally invasive pancreatoduodenectomy	Whipple's procedure using minimally invasive (laparoscopic/robotic) techniques

Timeline

• Start date: 2021-11-01
• Primary completion: 2022-03-01
• Completion: 2022-07-01
• First posted: 2022-07-28
• Last updated: 2022-07-28

Locations

1 site across 1 country: Italy