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

NCT ID: NCT03766555

Last Updated: 2023-02-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 76 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-21
• Study Completion Date: 2025-07-31

Brief 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.

Detailed Description

Hepatocellular carcinoma (HCC) is a common cancer and is diagnosed at an earlier stage and with increasing frequency because of the wider implementation of screening programs. Whether liver resection or local ablation should be the first-line treatment in early HCC remains a hot topic for debate. Both are regarded as acceptable curative treatment for early HCC in many international guidelines. Underlying liver function is the key in treatment selection. The general consensus is that liver resection should be the treatment of choice in patients with good liver function while local ablation should be considered in patients with poor liver function. There exists a group of patients with apparently good liver function that harbor significant liver cirrhosis which is not easily picked up by the current assessment or scoring systems. Liver resection in this group of patients is burdened by potentially life-threatening complications and the overall survival is limited by their underlying liver cirrhosis. This is particularly important in early HCC as local ablation is another curative treatment option. In order to improve the prognosis of patients with early HCC, it is important to identify (1) patients with liver dysfunction to the extend that the risk of liver resection will outweigh the survival benefit it provides; (2) the best ablative method for HCC.

The investigators propose to carry out a prospective randomized controlled study to compare the treatment outcome of microwave ablation with liver resection in patients with borderline liver function whose HCC that are amendable to both liver resection and microwave ablation.

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Microwave Ablation

Microwave ablation (MWA) will be performed in patients randomized to this arm.

Group Type: EXPERIMENTAL

Microwave ablation

Intervention Type: PROCEDURE

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.

Liver Resection

Liver resection will be performed in patients randomized to this arm.

Group Type: ACTIVE_COMPARATOR

Liver resection

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Age >18 years
• HCC amendable for both MWA and liver resection
• Liver function of ALBI Grade 2
• Tumour size </= 5cm
• Absence of extrahepatic metastasis
• Absence of radiology evidence of major vascular or bile duct invasion

Exclusion Criteria

• Informed consent not available
• Patients with ALBI 3, Child-Pugh B or above
• Multifocal tumour
• Presence of portal vein or hepatic artery thrombosis
• Anticipation of concomitant procedures
• Emergency hepatectomy
• Ruptured HCC
• Patients with chronic renal failure
• Pregnant female patients

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Charing Chong, MD

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Charing CN Chong, MBChB

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

Prince of Wales Hospital

Shatin, , Hong Kong

Site Status: RECRUITING

Countries

Hong Kong

Central Contacts

Chun Yeung, MSc

Role: CONTACT

philipyeung@surgery.cuhk.edu.hk

35053933

Facility Contacts

Charing CN Chong, MBChB

Role: primary

Related Links

http://www3.ha.org.hk/cancereg/pdf/overview/Summary%20of%20CanStat%202012.pdf

Hong Kong Hospital Authority. Hong Kong Cancer Registry. 2012.

Other Identifiers

2016.205

Identifier Type: -

Identifier Source: org_study_id