Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma

Recruiting

• Conditions: Disease-free Survival; Overall Survival
• Interventions: Procedure: Microwave ablation (MWA) versus Liver Resection (LR)

• Registration Number: NCT06462742
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

Thermal ablation has been recommended by worldwide guidelines as first-line treatment for hepatocellular carcinoma (HCC), while evidence regarding its efficacy for primary intrahepatic cholangiocarcinoma (iCCA) is lacking. The goal of this observational study is to study the efficacy of ablation in treating iCCA by comparing its prognosis with surgery. The main questions it aims to answer are:

* Whether microwave ablation could achieve similar efficacy with liver resection in treating iCCA

* What is the risk factor for ablation or surgery in treating iCCA

* What kind of iCCA patients could receive ablation as their first-line treatment In this real-world multicenter cohort study, we will collect data of iCCA patients from hospitals who underwent microwave ablation (MWA) or liver resection (LR) for tumors within Milan criteria. Survival will be compared between patients treated by MWA or LR.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01-01
• Study First Submitted: 2024-06-12
• Study First Submitted QC: 2024-06-12
• Study First Posted: 2024-06-17
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-24
• Last Update Posted: 2024-07-25
• Primary Completion: 2029-06-01
• Study Completion: 2029-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

1. pathologically diagnosed iCCA based on the WHO classifications;
2. curative-intent liver resection or microwave ablation;
3. tumor within Milan criteria, namely single tumor ≤5cm in maximum diameter; multiple tumors ≤3 in number and each ≤3cm; no evidence of major vascular/hilar invasion, extrahepatic/lymphatic metastasis or other malignancies;
4. age ≥18 years.

Exclusion Criteria

Patients not meeting any one of the inclusion criteria were excluded.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LR	Microwave ablation (MWA) versus Liver Resection (LR)	iCCA patients who underwent liver resection (LR)
MWA	Microwave ablation (MWA) versus Liver Resection (LR)	iCCA patients who underwent microwave ablation (MWA).

Primary Outcome Measures

Name	Time	Method
Disease-free survival	More than 3 years	DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier.
Overall survival	More than 3 years]	OS was defined as death related to any cause and was indexed from the date of ablation or surgery until last contact or death

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China