Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorChinese PLA General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Chinese patients pathologically diagnosed with intrahepatic cholangiocarcinoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Microwave ablation (MWA) versus Liver Resection (LR)
Procedure/SurgeryMicrowave 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.
Treatment groups
1,000 Participants
are divided into 2 treatment groupsGroup A: MWA1 intervention
Group B: LR1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
More than 3 years]2
Disease-free survival
DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier.
Time frame
More than 3 yearsSponsors and contacts
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Source ClinicalTrials.gov