NCT04365751

Brief Summary

The study was a prospective multicenter cohort control study, which was divided into 1:1 groups to compare the clinical efficacy of percutaneous microwave ablation and laparoscopic hepatocellular carcinoma resection (tumor diameter 3.1-5.0cm).

Trial Health

77
On Track

Trial Health Score

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

Enrollment
1,134

participants targeted

Target at P75+ for not_applicable hepatocellular-carcinoma

Timeline
6mo left

Started Dec 2019

Longer than P75 for not_applicable hepatocellular-carcinoma

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress92%
Dec 2019Dec 2026

Study Start

First participant enrolled

December 26, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 28, 2020

Completed
6.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

6.9 years

First QC Date

April 24, 2020

Last Update Submit

April 24, 2020

Conditions

Hepatocellular Carcinoma

Keywords

microwave ablation, hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

  • Overall survival

    Defined as the length of time from the beginning of treatment to death or the last follow-up (if no death).

    60 months

Secondary Outcomes (4)

  • Progression-free survival

    60 months

  • Intrahepatic recurrence rate

    60 months

  • Rate of extrahepatic metastasis

    60 months

  • Local rate of progression

    60 months

Study Arms (2)

Percutaneous microwave ablation group

EXPERIMENTAL

MWA (Microwave) is an ultrasound-guided, minimally invasive technique that implants ablation electrodes into target tissue to rapidly generate high temperatures and rapidly develop coagulative necrosis in tumor tissue, thereby achieving the goal of local tumor treatment.

Procedure: Percutaneous microwave ablation, Laparoscopic hepatectomy

Laparoscopic hepatectomy

OTHER

Laparoscopic hepatectomy is a widely used surgical technique in the treatment of benign (malignant) liver diseases

Procedure: Percutaneous microwave ablation, Laparoscopic hepatectomy

Interventions

Percutaneous microwave ablation, Laparoscopic hepatectomyPROCEDURE

For patients with hepatocellular carcinoma who meet the enrollment requirements, under the guidance of ultrasound, microwave ablation electrodes were implanted into the tumor tissues by percutaneous puncture, and the high-temperature heat energy was generated to cause coagulation necrosis of the tumor, so as to achieve the goal of local tumor treatment with minimally invasive technology.

Laparoscopic hepatectomyPercutaneous microwave ablation group

Eligibility Criteria

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

You may qualify if:

  • Older than 18 years old, regardless of gender; 2.In patients without cirrhosis background, hepatocellular carcinoma was definitely pathologically diagnosed within 1 month before surgery. In patients with cirrhosis background, dynamic contrast enhanced MRI/ multi-stage dynamic enhanced CT were used to determine the characteristic vascular signs of primary liver cancer (rapid heterogeneous vascular enhancement in arterial phase, rapid elution in venous phase or delayed phase); 3.The number of tumors was ≤3, and the maximum diameter of at least one tumor was 3.1-5.0cm; 4.No vascular and lymph node invasion and distant metastasis; 5.Liver function: child-pugh A or B (assessed within 14 days before surgery); 6.Subjects will understand the purpose of the study, voluntarily participate and sign the informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

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

Study Officials

  • Ping Liang, Doctor

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Yu, Doctor

CONTACT

8601066939530jiemi301@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Interventional ultrasound department

Study Record Dates

First Submitted

April 24, 2020

First Posted

April 28, 2020

Study Start

December 26, 2019

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 28, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)