NCT05478889

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
478

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 28, 2022

Completed
Last Updated

July 28, 2022

Status Verified

July 1, 2022

Enrollment Period

4 months

First QC Date

July 22, 2022

Last Update Submit

July 27, 2022

Conditions

Distal Cholangiocarcinoma

Keywords

Minimally invasive pancreatoduodenectomyWhippleDistal cholangiocarcinomaSurvival

Outcome Measures

Primary Outcomes (1)

  • Overall survival and disease-free interval

    Time-to-event data, months + occurrence of event (death or recurrence)

    60 months

Secondary Outcomes (1)

  • Major morbidity

    30 days or in-hospital

Study Arms (2)

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

Open pancreatoduodenectomy

Whipple or pylorus preserving pancreatoduodenectomy following open (laparotomy) approach.

Interventions

Minimally invasive pancreatoduodenectomyPROCEDURE

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

Minimally invasive pancreatoduodenectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • Adult patients
  • Elective upfront curative MIPD or OPD between January 1, 2010 and December 31, 2021
  • Pathological confirmed dCCA

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fondazione Poliambulanza Istituto Ospedaliero

Brescia, 25124, Italy

Location

Study Officials

  • Moh'd Abu Hilal, MD, PhD

    Fondazione Poliambulanza

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2022

First Posted

July 28, 2022

Study Start

November 1, 2021

Primary Completion

March 1, 2022

Study Completion

July 1, 2022

Last Updated

July 28, 2022

Record last verified: 2022-07

Locations

IT(1)