Extent of Intrahepatic Infiltration of Perihilar Cholangiocarcinoma

NCT06357117 | Completed

• 1 other identifier: A01263
• Study Type: observational
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

The extent of intrahepatic infiltration of perihilar cholangiocarcinoma (PHCC) remains unclear. This research aimed to explore the pattern and extent of intrahepatic infiltration of PHCC to guide surgical treatment and pathological research. This prospective study included 62 participants diagnosed with PHCC who underwent major hepatectomy. A whole-mount digital liver pathology system (WDLPS) for hepatectomy specimens greater than 10 × 10 cm was used to panoramically assess the intrahepatic infiltration extent of PHCC.

Conditions

Perihilar Cholangiocarcinoma

Outcome Measures

Primary Outcomes (1)

• Relapse-free survival (RFS).

  Refers to the survival time of a PHCC patient without recurrence of PHCC for a period of time after surgical treatment.

  RFS as of December 2023

Secondary Outcomes (1)

• Overall survival (OS).

  OS as of December 2023

Study Arms (2)

No RLI vs RLI

No RLI: PHCC patients without RLI. RLI: PHCC patients with RLI.

No DIHI vs DIHI

No DIHI: PHCC patients without DIHI. DIHI: PHCC patients with DIHI.

Eligibility Criteria

• Age: 44 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients were diagnosed for PHCC based on clinical manifestations, imaging, and pathological findings. All patients underwent hemihepatectomy or trisectionectomy combined with caudate lobectomy. Skeletonization resection of the hepatoduodenal ligament, including dissection of the regional lymph nodes, was performed from the duodenum to the liver. Clinical and pathological indicators of the patients were collected. Portal vein and hepatic artery invasion were defined as the primary or secondary branch in the resected side or the reserved side which was invaded.

You may qualify if:

• Patients were diagnosed for PHCC based on clinical manifestations, imaging, and pathological findings.
• Hepatectomy was performed.
• WDLPS was successfully produced.

You may not qualify if:

• Not PHCC patients.
• Patients with PHCC did not undergo hepatectomy.
• WDLPS was not successfully produced.

Sponsors & Collaborators

• Beijing Tsinghua Chang Gung Hospital: lead

Study Sites (1)

Beijing Tsinghua Chang Gung Hospital

Beijing, Beijing Municipality, 102218, China

Location

Related Publications (1)

• Jin S, Jiang N, Zhao JM, Xiao Y, Wang SY, Xiang CH, Lu Q, Shan SQ, Ruan HT, Yu SQ, Zeng JP, Yang SZ, Li L, Dong JH. Pattern and extent of intrahepatic infiltration of perihilar cholangiocarcinoma - a case-control study based on liver panoramic digital pathology. Int J Surg. 2025 Jan 1;111(1):31-39. doi: 10.1097/JS9.0000000000002040.

  PMID: 39166939 DERIVED

MeSH Terms

Conditions

Klatskin Tumor

Condition Hierarchy (Ancestors)

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

Study Officials

• Shuo Jin, PhD

  Beijing Tsinghua Changgung Hospital affiliated to Tsinghua University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 10, 2024
• Study Start: April 13, 2018
• Primary Completion: December 22, 2021
• Study Completion: December 22, 2021
• Last Updated: April 11, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)