Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma

NCT ID: NCT05478889

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 478 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-11-01
• Study Completion Date: 2022-07-01

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.

Conditions

Distal Cholangiocarcinoma

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Minimally invasive pancreatoduodenectomy

Intervention Type: PROCEDURE

Whipple's procedure using minimally invasive (laparoscopic/robotic) techniques

Open pancreatoduodenectomy

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

No interventions assigned to this group

Interventions

Minimally invasive pancreatoduodenectomy

Whipple's procedure using minimally invasive (laparoscopic/robotic) techniques

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fondazione Poliambulanza Istituto Ospedaliero

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Moh'd Abu Hilal, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Poliambulanza

Locations

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, , Italy

Countries

Italy

Other Identifiers

FPoliambulanza

Identifier Type: -

Identifier Source: org_study_id