NCT03766555

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 21, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 16, 2018

Completed
5 months until next milestone

First Posted

Study publicly available on registry

December 6, 2018

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2023

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

February 13, 2023

Status Verified

February 1, 2023

Enrollment Period

5.1 years

First QC Date

July 16, 2018

Last Update Submit

February 9, 2023

Conditions

Carcinoma, Hepatocellular

Keywords

Hepatocellular carcinomaHepatectomyMicrowave AblationLocal Ablation

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    The primary outcome of this study is the overall survival

    5 years

Secondary Outcomes (4)

  • Disease-free survival

    5 years

  • Recurrence rate

    5 years

  • Morbidity rate

    1 year

  • Hospital stay

    1 year

Study Arms (2)

Microwave Ablation

EXPERIMENTAL

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

Procedure: Microwave ablation

Liver Resection

ACTIVE COMPARATOR

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

Procedure: Liver resection

Interventions

Microwave ablationPROCEDURE

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.

Microwave Ablation
Liver resectionPROCEDURE

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.

Liver Resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

RECRUITING

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Charing CN Chong, MBChB

    Chinese University of Hong Kong

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun Yeung, MSc

CONTACT

35053933philipyeung@surgery.cuhk.edu.hk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 16, 2018

First Posted

December 6, 2018

Study Start

May 21, 2018

Primary Completion

July 1, 2023

Study Completion

July 1, 2025

Last Updated

February 13, 2023

Record last verified: 2023-02

Locations

HK(1)