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Microwave Ablation Versus Liver Resection For Early Hepatocellular Carcinoma in Patients With Borderline Liver Function

NCT03766555 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2023-02-13

No results posted yet for this study

Summary

We propose a randomized controlled study to compare the treatment efficacy of microwave ablation to liver resection for hepatocellular carcinoma (HCC) in patients with borderline liver function.

Conditions

  • Carcinoma, Hepatocellular

Interventions

PROCEDURE

Microwave ablation

Microwave ablation will be performed in operation theatre under general anesthesia via laparoscopic or open approach according to the tumors' locations. In case of open approach, it will be done via a right subcostal incision with possible upper midline extension was necessary. After diagnostic laparoscopy in laparoscopic approach and exploratory laparotomy in open approach to exclude the presence of extra-hepatic disease, operative ultrasound (Aloka, Tokyo, Japan) will be performed to exclude preoperatively undetected lesion; guide insertion of the microwave applicator; and monitor the whole ablation process. Surrounding organs were cooled by constant irrigation of ice-cold saline to prevent thermal injury. The ablation will be carried out according to the standard protocol with the aim to create a 1cm ablation margin around the tumor. The insertion track will be burnt after ablation in order to prevent bleeding and tumor seeding.

PROCEDURE

Liver resection

Liver resection will be performed as described previously. Liver parenchymal transection would be performed with CUSA (cavitron ultrasonic surgical aspirator) and TissueLink (a radiofrequency saline-linked dissecting sealer) in both arms. Vascular staplers would be used to divide major vascular pedicles. Fibrin glue (Tisseel) spray would be applied to the parenchymal cut surface of the liver before closure of abdomen.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Charing CN Chong, MBChB · Chinese University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-05-21
Primary Completion
2023-07-31
Completion
2025-07-31

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03766555 on ClinicalTrials.gov