Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma

Overall Survival Clinical Trial

— MALRIC  

Official title:

Microwave Ablation Versus Liver Resection for Intrahepatic Cholangiocarcinoma Within Milan Criteria

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06462742
• Other study ID #: S2024-0606
• Status: Recruiting
• Start date: January 1, 2009
• Est. completion date: June 1, 2029

Study information

• Verified date: June 2024
• Source: Chinese PLA General Hospital
• Contact: Chuan Pang, Doctor
• Phone: +86-18910527022
• Email: pcpang117[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: June 1, 2029
• Est. primary completion date: June 1, 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cholangiocarcinoma
• Disease-free Survival
• Overall Survival

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]
Primary	Disease-free survival	DFS was defined as the time interval between first treatment and recurrence or death, whichever occurred earlier.	More than 3 years