Central Obesity and Hepatocellular Carcinoma

Obesity Clinical Trial

Official title:

Central Obesity and the Prognosis of Hepatocellular Carcinoma After Microwave Ablation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03082378
• Other study ID #: 301jrcsk
• Status: Recruiting
• Phase: N/A
• First received: March 12, 2017
• Last updated: March 16, 2017
• Start date: March 1, 2017
• Est. completion date: December 31, 2019

Study information

• Verified date: March 2017
• Source: Chinese PLA General Hospital
• Contact: Jie Yu, Dr
• Phone: 66939530
• Email: yu-jie301[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 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:

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

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma
• Microwave Ablation
• Obesity
• Obesity, Abdominal

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