Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma

NCT ID: NCT06462742

Last Updated: 2024-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-01-01

Study Completion Date

2029-06-01

Brief Summary

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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

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Conditions

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Overall Survival Disease-free Survival

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MWA

iCCA patients who underwent microwave ablation (MWA).

Microwave ablation (MWA) versus Liver Resection (LR)

Intervention Type PROCEDURE

Microwave ablation (MWA) is one of the newer modality of thermal ablation and has proven its safety and efficacy in the management of the tumors amenable for ablation for primary and metastatic diseases.

Liver resection is a surgery to remove part of the liver to eradicate tumors.

LR

iCCA patients who underwent liver resection (LR)

Microwave ablation (MWA) versus Liver Resection (LR)

Intervention Type PROCEDURE

Microwave ablation (MWA) is one of the newer modality of thermal ablation and has proven its safety and efficacy in the management of the tumors amenable for ablation for primary and metastatic diseases.

Liver resection is a surgery to remove part of the liver to eradicate tumors.

Interventions

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Microwave ablation (MWA) versus Liver Resection (LR)

Microwave ablation (MWA) is one of the newer modality of thermal ablation and has proven its safety and efficacy in the management of the tumors amenable for ablation for primary and metastatic diseases.

Liver resection is a surgery to remove part of the liver to eradicate tumors.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ping Liang

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Chuan Pang, Doctor

Role: CONTACT

+86-18910527022

Facility Contacts

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Ping Liang, Doctor

Role: primary

Other Identifiers

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S2024-0606

Identifier Type: -

Identifier Source: org_study_id

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