RecruitingNot ApplicableNCT02886104

Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis

Comparison of Hepatectomy and Local Ablation for Resectable Synchronous and Metachronous Colorectal Liver Metastasis (HELARC) ------ a Randomized Controlled Multicenter Clinical Study


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

548 participants

Start Date

Aug 1, 2016

Study Type

INTERVENTIONAL

Conditions

Summary

The surgical and local ablation strategy for the treatment of resectable synchronous and metachronous colorectal liver metastases(CRLM) has not still been defined. The purpose of this study is to compare two treatment strategies in which simultaneous resection of both primary and secondary tumor of synchronous CRLM(SCRLM) and resection of metachronous CRLM(MCRLM) is compared with resection of primary tumor and ablation of secondary tumor in SCRLM and ablation of MCRLM. Endpoints include the rate of severe complications and survival.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study compares two treatments for colorectal cancer (bowel cancer) that has spread to the liver: surgical removal of the liver tumors (hepatectomy) versus destroying the tumors using heat or cold (ablation), to determine which is more effective. **You may be eligible if...** - You have colorectal cancer (colon or rectal cancer) confirmed by biopsy - Your cancer has spread to the liver (liver metastases), also confirmed by biopsy - You do not have cancer spread to other organs - You are healthy enough for surgery or ablation **You may NOT be eligible if...** - Your cancer has spread to places other than the liver that cannot all be fully treated - You have active complications like a bowel blockage or internal bleeding - You are not healthy enough to safely undergo surgery or anesthesia Finding the best way to treat liver metastases from bowel cancer could significantly improve survival. Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURECRLM resection group

Simultaneous resection of both primary and secondary tumors in synchronous CRLM or resection of metachronous CRLM.

DEVICECRLM ablation group

Microwave ablation of CRLM with a 2.15-gigahertz(GHz) microwave generator and a 14 gauge diameter transcutaneous antenna within 30 days after resection of primary tumor in synchronous CRLM or ablation of metachronous CRLM.


Locations(1)

The 6th Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

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NCT02886104