Central Obesity and Hepatocellular Carcinoma

NCT ID: NCT03082378

Last Updated: 2017-03-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatocellular Carcinoma Obesity Microwave Ablation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CROSSOVER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Chinese PLA General Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yu Jie

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jie Yu, Dr

Role: PRINCIPAL_INVESTIGATOR

Chinese PLA General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Jie Yu, Dr

Role: CONTACT

Meng-juan Mu, BM

Role: CONTACT

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Mengjuan Mu

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

301jrcsk

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.