Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma

Fondazione Poliambulanza Istituto Ospedaliero

Status: Completed

Conditions: Distal Cholangiocarcinoma

Treatments: Procedure: Minimally invasive pancreatoduodenectomy

Study type: Observational

Funder types: Other

Identifiers

NCT05478889

FPoliambulanza

Details and patient eligibility

About

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).

Full 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.

Enrollment: 478 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Adult patients
• Elective upfront curative MIPD or OPD between January 1, 2010 and December 31, 2021
• Pathological confirmed dCCA

Exclusion criteria

• Neoadjuvant chemotherapy
• Palliative surgical procedures
• Intraoperative detection of unresectable disease (i.e., metastasis or locally advanced disease)
• Post-operative pathological diagnosis was other than dCCA (e.g., neuroendocrine tumor, polyposis adenoma)
• R2 positive resection margin
• Pregnancy
• Missing primary endpoints

Trial design

478 participants in 2 patient groups

Minimally invasive pancreatoduodenectomy

Description:

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

Treatment:

Procedure: Minimally invasive pancreatoduodenectomy

Open pancreatoduodenectomy

Description:

Whipple or pylorus preserving pancreatoduodenectomy following open (laparotomy) approach.