Central Obesity and Hepatocellular Carcinoma

• Conditions: Obesity; Hepatocellular Carcinoma; Microwave Ablation

• Registration Number: NCT03082378
• Lead Sponsor: Chinese PLA General Hospital

Brief Summary

Recurrence and metastases after microwave ablation(MWA) of hepatocellular carcinoma(HCC) are the major factors that influence the survival. Obesity has been reported was significantly correlated with increased risk of developing HCC.

In this study, we will analysis the association of multiple obesity index(waist circumference,waist-hip ratio and body mass index) with the prognosis of HCC treated by MWA.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-03
• Study Start: 2017-03-01
• Study First Submitted: 2017-03-12
• Study First Submitted QC: 2017-03-16
• Last Update Submitted: 2017-03-16
• Study First Posted: 2017-03-17
• Last Update Posted: 2017-03-17
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
survival	3 years	Percentage of participants who survived up to end time point as assessed by Kaplan-Meier

Secondary Outcome Measures

Name	Time	Method
intra-hepatic metastasis	3 years	Percentage of participants who present metastasis in the liver up to end time point as assessed by Kaplan-Meier
extra-hepatic metastasis	3 years	Percentage of participants who present metastasis outside the liver up to end time point as assessed by Kaplan-Meier
local tumor progression	3 years	Percentage of participants who present tumor progression around the ablation zone up to end time point as assessed by Kaplan-Meier
complication	3 years	number of participants with side effect and major complication

Trial Locations

Locations (1)

Chinese PLA General Hospital; 🇨🇳 Beijing, Beijing, China