Minimally Invasive Pancreatoduodenectomy for Distal Cholangiocarcinoma

July 27, 2022 updated by: Fondazione Poliambulanza Istituto Ospedaliero

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

478

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Brescia, Italy, 25124
        • Fondazione Poliambulanza Istituto Ospedaliero

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All adult patients after elective upfront curative MIPD or OPD between January 1, 2010 and December 31, 2021 with a pathological confirmed dCCA

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Minimally invasive pancreatoduodenectomy
Whipple's procedure using minimally invasive (laparoscopic/robotic) techniques
Open pancreatoduodenectomy
Whipple or pylorus preserving pancreatoduodenectomy following open (laparotomy) approach.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Poliambulanza Istituto Ospedaliero

Investigators

  • Principal Investigator: Moh'd Abu Hilal, MD, PhD, Fondazione Poliambulanza

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2021

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

July 1, 2022

Study Registration Dates

First Submitted

July 22, 2022

First Submitted That Met QC Criteria

July 27, 2022

First Posted (Actual)

July 28, 2022

Study Record Updates

Last Update Posted (Actual)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 27, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FPoliambulanza

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Upon reasonable request it would be possible to share data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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