Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma
MALRIC
1 other identifier
observational
1,000
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2009
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 12, 2024
CompletedFirst Posted
Study publicly available on registry
June 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
July 25, 2024
July 1, 2024
20.4 years
June 12, 2024
July 24, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Overall survival
OS was defined as death related to any cause and was indexed from the date of ablation or surgery until last contact or death
More than 3 years]
Disease-free survival
DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier.
More than 3 years
Study Arms (2)
MWA
iCCA patients who underwent microwave ablation (MWA).
LR
iCCA patients who underwent liver resection (LR)
Interventions
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.
Eligibility Criteria
Chinese patients pathologically diagnosed with intrahepatic cholangiocarcinoma
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853, China
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 12, 2024
First Posted
June 17, 2024
Study Start
January 1, 2009
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
July 25, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share