Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma

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 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

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