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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03045952
Recruitment Status : Unknown
Verified February 2017 by Ping Liang, Chinese PLA General Hospital.
Recruitment status was:  Recruiting
First Posted : February 8, 2017
Last Update Posted : February 8, 2017
Sponsor:
Information provided by (Responsible Party):
Ping Liang, Chinese PLA General Hospital

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.

Condition or disease Intervention/treatment Phase
Liver Neoplasms Procedure: microwave ablation device Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Percutaneous Microwave Ablation Under Ultrasound Guidance for Primary Liver Cancer: a Multicenter Analysis
Study Start Date : January 2013
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Cancer

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.
Procedure: microwave ablation device
Microwave ablation is a technique that uses thermal therapy to induce complete necrosis of tumor in situ by using microwave ablation device.




Primary Outcome Measures :
  1. overall survival [ Time Frame: 5 years ]

Secondary Outcome Measures :
  1. intrahepatic metastasis [ Time Frame: 5 years ]
  2. extrahepatic metastasis [ Time Frame: 5 years ]
  3. local tumor progress [ Time Frame: 5 years ]
  4. complication [ Time Frame: 1 month ]
    number of participants with side effect and major complication

  5. disease free survival [ Time Frame: 5 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03045952


Contacts
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Contact: jie Yu, Dr. 8610-66939530 yu-jie301@hotmail.com
Contact: Ping Liang, Dr. 8610-66939530 liangping301@hotmail.com

Locations
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China, Beijing
Chinese PLA General Hospital Recruiting
Beijing, Beijing, China, 100853
Contact: Jie Yu, Doctor    8610-66939530    yu-jie301@hotmail.com   
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: Ping Liang, Dr. Chinese PLA General Hospital

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Responsible Party: Ping Liang, Professor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03045952    
Other Study ID Numbers: 66939530lp
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: February 8, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Ping Liang, Chinese PLA General Hospital:
Multicenter study
microwave
Additional relevant MeSH terms:
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Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Liver Diseases