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

Liver Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03045952
• Other study ID #: 66939530lp
• Status: Completed
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2020

Study information

• Verified date: March 2021
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1908
• Est. completion date: December 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Liver Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Chinese PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	overall survival		5 years
Secondary	intrahepatic metastasis		5 years
Secondary	extrahepatic metastasis		5 years
Secondary	local tumor progress		5 years
Secondary	complication	number of participants with side effect and major complication	1 month
Secondary	disease free survival		5 years