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

NCT06222619 | Completed

• 1 other identifier: H-2001-092-1095
• Study Type: observational
• Target: 136
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Biliary Tract Cancer; Portal Vein Embolization

Outcome Measures

Primary Outcomes (1)

• Overall survival

  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 Outcomes (1)

• Recurrence free survival

  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

Study Arms (3)

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

No resection after PVE

No resection of bile duct and associated hemi-liver after portal vein embilzation

Procedure: Potal vein embilization

Interventions

Potal vein embilization PROCEDURE

Portal vein of involved bile duct is embolized to increase the volume of remnant liver.

Also known as: Surgical resection

No resection after PVE; Resection after PVE

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with Bismuth type III-IV perihilar cholangiocarcinoma

You may qualify if:

• patients with Bismuth type III or IV stricture on radiological examination, including computed tomography (CT) or magnetic resonance cholangiography
• 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.

You may not qualify if:

• patients with unresectable perihilar cholangiocarcinoma
• patients who refused treatment
• patients with other concomitant malignancies.

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

MeSH Terms

Conditions

Biliary Tract Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Biliary Tract Diseases; Digestive System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 25, 2024
• Study Start: January 30, 2020
• Primary Completion: August 30, 2021
• Study Completion: August 30, 2023
• Last Updated: January 25, 2024

Record last verified: 2024-01

Locations

KR (1)