Percutaneous Microwave Ablation Under Ultrasound Guidance for Liver Cancer: a Multicenter Analysis

March 2, 2021 updated by: Ping Liang, Chinese PLA General Hospital

Percutaneous Microwave Ablation Under Ultrasound Guidance for Primary Liver Cancer: a Multicenter Analysis

Ultrasound-guided percutaneous MWA of liver cancer is a relatively new technique with favorable long-term outcomes.Butthe results are mainly from single center reports.A larger scale data need to be analyzed to evaluate the technique. This study is designed to investigated the efficacy of cooled-tip microwave ablation (MWA) for primary liver cancer (PLC) and analyzed the prognostic factors on a multicenter database.Between January 2013 and December 2018, all the PLC patients underwent ultrasound-guided percutaneous cooled-tip MWA as a primary treatment will be enrolled from at least ten Chinese institutions with different levels of MWA experience. All the patients will be closely followed up until June 2019. Clinicopathologic data, recurrence and survival estimates, complications and prognosis-relative factors will be measured.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1908

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Beijing
      • Beijing, Beijing, China, 100853
        • Chinese PLA General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • absence of ascites or the depth of ascites on US detection less than 4 cm;
  • a normal serum total bilirubin level or less than 60 µmol/L;
  • a normal albumin level or not less than 30 g/L;
  • for radical treatment, single lesion of 8 cm or smaller, three or fewer multiple lesions with a maximum diameter of 4 cm or less, absence of portal vein cancerous thrombus or extrahepatic metastases;
  • for palliative treatment, those with large or multiple lesions, suffering multiple metastases and unsuitable for other modalities can be considered to undergo the MWA on the condition of good hepatic function and blood coagulation function to tolerate the procedure.

Exclusion Criteria:

Contraindications include patients who have

  1. clinical evident liver failure, such as massive ascites or hepatic encephalopathy or with a trance-like state;
  2. severe blood coagulation dysfunction (prothrombin time of more than 30 seconds, prothrombin activity less than 40%, and platelet count less than 30 cells×109/L);
  3. high intrahepatic tumor burden (tumor volume >70% of the target liver volume or multiple tumor nodules) or high extrahepatic tumor burden;
  4. acute or active inflammatory and infectious lesions at any organ;
  5. acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction;
  6. relative contraindication concerns medical risk for the tumor proximity to diaphragm, gastrointestinal tract, gallbladder, pancreas, hepatic hilum and major bile duct or vessels, which may require adjunctive techniques to prevent off-target heating of adjacent structures during the ablation procedure.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: microwave ablation
Antenna in the microwave ablation device was percutaneously inserted into the tumor and placed at designated place under US guidance. For tumors less than 1.5 cm, one antenna was inserted and for tumors measuring 1.5 cm or greater, two antennae were inserted in parallel with an inter-antenna distance of 1.0-2.5 cm, which were used simultaneously during MWA to obtain larger ablation zone. A 20G thermocouple was inserted about 0.5-1 cm away from the tumor for real-time temperature monitoring during MWA. MW emission didn't stop until the heat-generated hyperechoic water vapor completely encompassed the entire tumor and the measured temperature reached 60°C or remained above 54°C for at least three minutes.
Microwave ablation is a technique that uses thermal therapy to induce complete necrosis of tumor in situ by using microwave ablation device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
overall survival
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
disease free survival
Time Frame: 5 years
5 years
intrahepatic metastasis
Time Frame: 5 years
5 years
extrahepatic metastasis
Time Frame: 5 years
5 years
local tumor progress
Time Frame: 5 years
5 years
complication
Time Frame: 1 month
number of participants with side effect and major complication
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Ping Liang, Dr., Chinese PLA General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Actual)

December 1, 2019

Study Completion (Actual)

December 1, 2020

Study Registration Dates

First Submitted

December 26, 2016

First Submitted That Met QC Criteria

February 7, 2017

First Posted (Estimate)

February 8, 2017

Study Record Updates

Last Update Posted (Actual)

March 4, 2021

Last Update Submitted That Met QC Criteria

March 2, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 66939530lp

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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