Volume-Restricted Resection for Perihilar Cholangiocarcinoma

NCT07149558 | Not Yet Recruiting DMC

• 1 other identifier: TJ-IRB202507012
• Study Type: observational
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this observational study is to learn about the safety and long-term outcomes of volume-restricted liver resection in patients with perihilar cholangiocarcinoma (pCCA) who have an insufficient future liver remnant (FLR). The main question it aims to answer is: Does volume-restricted liver resection improve surgical safety and long-term survival compared with standard treatment in pCCA patients with insufficient FLR? Participants with insufficient FLR who undergo volume-restricted liver resection or receive non-surgical treatment as part of their routine medical care will be followed for survival, postoperative complications, and other clinical outcomes. Data from patients with sufficient FLR undergoing standard radical resection will also be collected for comparison.

Conditions

Cholangiocarcinoma, Hilar

Outcome Measures

Primary Outcomes (1)

• Overall survival

  The period from the time when the patient was diagnosed with the disease or began receiving corresponding treatment until his or her death due to any cause.

  From the date of surgery/treatment until death or study termination, approximately 5 years.

Secondary Outcomes (5)

• Progression-free survival

  Disease progression/death

• R0 resection rate

  Within 7 days after surgery(pathology report)

• 90-day mortality

  90 days after the surgery

• Health-Related Quality of Life (HRQoL)

  Surgical patients will receive monthly safety follow-ups (30 ± 7 days) for 3 months after discharge. All patients will have telephone survival/recurrence follow-ups every 2 months (60 ± 14 days) until death, loss to follow-up, or study end.

• Incidence of postoperative complications

  Within 90 days after the operation

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 with perihilar cholangiocarcinoma and insufficient future liver remnant will be consecutively enrolled according to the inclusion and exclusion criteria. In addition, to better characterize the long-term survival of pCCA patients after surgical treatment, data from patients undergoing standard radical resection for pCCA will also be collected.

You may qualify if:

• Patients with pathologically confirmed hilar cholangiocarcinoma, or those with a high index of clinical suspicion for hilar bile duct malignancy despite the lack of histological confirmation.
• Patients who are able to understand and cooperate with this study.
• Patients who are able to provide and sign the written informed consent form before undergoing any screening procedures related to the study.

You may not qualify if:

• Patients with preoperatively or intraoperatively confirmed distant metastasis, including peritoneal dissemination, distant lymph node metastasis, hepatic or other organ metastasis.
• Patients who underwent palliative surgery only.

Sponsors & Collaborators

• Yongjun Chen: lead

MeSH Terms

Conditions

Klatskin Tumor

Condition Hierarchy (Ancestors)

Cholangiocarcinoma; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Yongjun Chen, Ph.D.

CONTACT

+862783665315; yjchen@tjh.tjmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: September 2, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2034
• Last Updated: September 2, 2025

Record last verified: 2025-08