Effect of PVE on Surgical Outcomes and Long-term Survival in Perihilar Cholangiocarcinoma

January 20, 2024 updated by: Sang Hyub Lee, Seoul National University Hospital

Effect of Portal Vein Embolization on Surgical Outcomes and Long-term Survival in Patients With Perihilar Cholangiocarcinoma

Portal vein embolization is often recommended to reduce the risk of postoperative liver failure and mortality. In this retrospective cohort study, researchers investigated the effect of portal vein embolization in patients with resectable perihilar cholangiocarcinoma bismuth type III and IV.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

136

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

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with Bismuth type III-IV perihilar cholangiocarcinoma

Description

Inclusion Criteria:

  1. patients with Bismuth type III or IV stricture on radiological examination, including computed tomography (CT) or magnetic resonance cholangiography
  2. patients with perihilar cholangiocarcinoma histologically confirmed by surgical resection or forceps biopsy/brush cytology under endoscopic retrograde cholangiopancreatography or through the percutaneous transhepatic biliary drainage tract.

Exclusion Criteria:

  1. patients with unresectable perihilar cholangiocarcinoma
  2. patients who refused treatment
  3. patients with other concomitant malignancies.

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
Resection without PVE
Resection of bile duct and associated hemi-liver without portal vein embilzation
Resection after PVE
Resection of bile duct and associated hemi-liver after portal vein embilzation
Procedure: Potal vein embilization
Portal vein of involved bile duct is embolized to increase the volume of remnant liver.
Other Names:
  • Surgical resection
No resection after PVE
No resection of bile duct and associated hemi-liver after portal vein embilzation
Procedure: Potal vein embilization
Portal vein of involved bile duct is embolized to increase the volume of remnant liver.
Other Names:
  • Surgical resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival
Time Frame: The time from diagnosis until the date of death or last date of follow-up or end of study up to 24 months
Overall survival of each group (A-C).
The time from diagnosis until the date of death or last date of follow-up or end of study up to 24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence free survival
Time Frame: The time from surgical resection until the date of recurrence or death or last date of follow-up or end of study up to 24 months
Recurrence free survival of patients who underwent surgical resection
The time from surgical resection until the date of recurrence or death or last date of follow-up or end of study up to 24 months

Collaborators and Investigators

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

Sponsor

Seoul National University Hospital

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)

January 30, 2020

Primary Completion (Actual)

August 30, 2021

Study Completion (Actual)

August 30, 2023

Study Registration Dates

First Submitted

January 11, 2024

First Submitted That Met QC Criteria

January 20, 2024

First Posted (Estimated)

January 25, 2024

Study Record Updates

Last Update Posted (Estimated)

January 25, 2024

Last Update Submitted That Met QC Criteria

January 20, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2001-092-1095

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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