Brief Title
Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma
Official Title
Surgical and Oncological Outcome After Minimally Invasive and Open Pancreatoduodenectomy for Distal Cholangiocarcinoma: an International Propensity Score Cohort Study
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.
Study Type
Observational
Primary Outcome
Overall survival and disease-free interval
Secondary Outcome
Major morbidity
Condition
Distal Cholangiocarcinoma
Intervention
Minimally invasive pancreatoduodenectomy
Study Arms / Comparison 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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
478
Start Date
November 1, 2021
Completion Date
July 1, 2022
Primary Completion Date
March 1, 2022
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Moh'd Abu Hilal, MD, PhD, ,
Location Countries
Italy
Location Countries
Italy
Administrative Informations
NCT ID
NCT05478889
Organization ID
FPoliambulanza
Responsible Party
Sponsor
Study Sponsor
Fondazione Poliambulanza Istituto Ospedaliero
Study Sponsor
Moh'd Abu Hilal, MD, PhD, Principal Investigator, Fondazione Poliambulanza
Verification Date
July 2022