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

Biliary Tract Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06222619
• Other study ID #: H-2001-092-1095
• Status: Completed
• Start date: January 30, 2020
• Est. completion date: August 30, 2023

Study information

• Verified date: January 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: August 30, 2023
• Est. primary completion date: August 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Cholangiocarcinoma
• Klatskin Tumor

Intervention

Procedure:
• Potal vein embilization
Portal vein of involved bile duct is embolized to increase the volume of remnant liver.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Recurrence free survival	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