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

Primary Purpose

Liver Neoplasms

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
microwave ablation device
Sponsored by
Chinese PLA General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Neoplasms focused on measuring Multicenter study, microwave

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Chinese PLA General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

microwave ablation

Arm Description

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.

Outcomes

Primary Outcome Measures

overall survival

Secondary Outcome Measures

intrahepatic metastasis
extrahepatic metastasis
local tumor progress
complication
number of participants with side effect and major complication
disease free survival

Full Information

First Posted
December 26, 2016
Last Updated
March 2, 2021
Sponsor
Chinese PLA General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03045952
Brief Title
Percutaneous Microwave Ablation Under Ultrasound Guidance for Liver Cancer: a Multicenter Analysis
Official Title
Percutaneous Microwave Ablation Under Ultrasound Guidance for Primary Liver Cancer: a Multicenter Analysis
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2019 (Actual)
Study Completion Date
December 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Neoplasms
Keywords
Multicenter study, microwave

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1908 (Actual)

8. Arms, Groups, and Interventions

Arm Title
microwave ablation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
microwave ablation device
Intervention Description
Microwave ablation is a technique that uses thermal therapy to induce complete necrosis of tumor in situ by using microwave ablation device.
Primary Outcome Measure Information:
Title
overall survival
Time Frame
5 years
Secondary Outcome Measure Information:
Title
intrahepatic metastasis
Time Frame
5 years
Title
extrahepatic metastasis
Time Frame
5 years
Title
local tumor progress
Time Frame
5 years
Title
complication
Description
number of participants with side effect and major complication
Time Frame
1 month
Title
disease free survival
Time Frame
5 years

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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 clinical evident liver failure, such as massive ascites or hepatic encephalopathy or with a trance-like state; 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); high intrahepatic tumor burden (tumor volume >70% of the target liver volume or multiple tumor nodules) or high extrahepatic tumor burden; acute or active inflammatory and infectious lesions at any organ; acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction; 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ping Liang, Dr.
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100853
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No

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

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