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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05478889

Enrollment

478

Registered

2022-07-28

Start date

2021-11-01

Completion date

2022-07-01

Last updated

2022-07-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Distal Cholangiocarcinoma

Keywords

Minimally invasive pancreatoduodenectomy, Whipple, Distal cholangiocarcinoma, Survival

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.

Interventions

PROCEDUREMinimally invasive pancreatoduodenectomy

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

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Major morbidity	30 days or in-hospital	Clavien-Diendo 3b-5

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026