Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma

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.

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Key information

Conditions

Overall Survival Disease-Free Survival

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location status: Recruiting

Location contact

Ping Liang, Doctor

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

pathologically diagnosed iCCA based on the WHO classifications;
curative-intent liver resection or microwave ablation;
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;
age ≥18 years.

Exclusion criteria

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

Treatment and study plan

Microwave ablation (MWA) versus Liver Resection (LR)

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.

Primary outcomes

Overall survival

Time frame: 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
Disease-free survival

Time frame: More than 3 years

DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier.

Study contacts

Contact information is provided by the study sponsor or research team.

Chuan Pang, Doctor

CONTACT

[email protected]

+86-18910527022

Sponsors and collaborators

Lead sponsor

Chinese PLA General Hospital

Other

Registry information

Official study title

Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma Within Milan Criteria

Acronym: MALRIC

Important dates

Study start: 2009
Primary completion: 2029
Study completion: 2029
First posted: Jun 17, 2024
Registry last updated: Jul 25, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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