Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Distal Cholangiocarcinoma

Intervention / Treatment
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* Procedure: Minimally invasive pancreatoduodenectomy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Minimally invasive pancreatoduodenectomy<br>Whipple or pylorus preserving pancreatoduodenectomy following minimally invasive approach (laparoscopic or robotic). Hybrid (hand assisted) precedures will be included in the minimally invasive cohort. | Procedure: Minimally invasive pancreatoduodenectomy<br>* Whipple's procedure using minimally invasive (laparoscopic/robotic) techniques<br>|
| Open pancreatoduodenectomy<br>Whipple or pylorus preserving pancreatoduodenectomy following open (laparotomy) approach. | |

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Minimally invasive pancreatoduodenectomy, Whipple, Distal cholangiocarcinoma, Survival