Microwave Ablation Versus Liver Resection For Early Hepatocellular Carcinoma in Patients With Borderline Liver Function
Primary Purpose
Carcinoma, Hepatocellular
Status
Recruiting
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Microwave ablation
Liver resection
Sponsored by
About this trial
This is an interventional treatment trial for Carcinoma, Hepatocellular focused on measuring Hepatocellular carcinoma, Hepatectomy, Microwave Ablation, Local Ablation
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
Sites / Locations
- Prince of Wales HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Microwave Ablation
Liver Resection
Arm Description
Microwave ablation (MWA) will be performed in patients randomized to this arm.
Liver resection will be performed in patients randomized to this arm.
Outcomes
Primary Outcome Measures
Overall survival
The primary outcome of this study is the overall survival
Secondary Outcome Measures
Disease-free survival
Disease-free survival
Recurrence rate
Liver cancer recurrence rate
Morbidity rate
Morbidity rate
Hospital stay
Hospital length of stay
Full Information
NCT ID
NCT03766555
First Posted
July 16, 2018
Last Updated
February 9, 2023
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT03766555
Brief Title
Microwave Ablation Versus Liver Resection For Early Hepatocellular Carcinoma in Patients With Borderline Liver Function
Official Title
Microwave Ablation Versus Liver Resection For Early Hepatocellular Carcinoma in Patients With Borderline Liver Function
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 21, 2018 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
July 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Hepatocellular
Keywords
Hepatocellular carcinoma, Hepatectomy, Microwave Ablation, Local Ablation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a prospective randomized study to be conducted in an academic hospital with a specialized hepato-biliary team. The principal investigator and other members within the team will perform patient selection and recruitment of this study according to the inclusion and exclusion criteria.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
76 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Microwave Ablation
Arm Type
Experimental
Arm Description
Microwave ablation (MWA) will be performed in patients randomized to this arm.
Arm Title
Liver Resection
Arm Type
Active Comparator
Arm Description
Liver resection will be performed in patients randomized to this arm.
Intervention Type
Procedure
Intervention Name(s)
Microwave ablation
Intervention Description
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
Intervention Name(s)
Liver resection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Overall survival
Description
The primary outcome of this study is the overall survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Disease-free survival
Description
Disease-free survival
Time Frame
5 years
Title
Recurrence rate
Description
Liver cancer recurrence rate
Time Frame
5 years
Title
Morbidity rate
Description
Morbidity rate
Time Frame
1 year
Title
Hospital stay
Description
Hospital length of stay
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chun Yeung, MSc
Phone
35053933
Email
philipyeung@surgery.cuhk.edu.hk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Charing CN Chong, MBChB
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Charing CN Chong, MBChB
12. IPD Sharing Statement
Links:
URL
http://www3.ha.org.hk/cancereg/pdf/overview/Summary%20of%20CanStat%202012.pdf
Description
Hong Kong Hospital Authority. Hong Kong Cancer Registry. 2012.
Learn more about this trial
Microwave Ablation Versus Liver Resection For Early Hepatocellular Carcinoma in Patients With Borderline Liver Function
We'll reach out to this number within 24 hrs