NCT03082378

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2017

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

March 12, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 17, 2017

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

March 17, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

March 12, 2017

Last Update Submit

March 16, 2017

Conditions

Hepatocellular CarcinomaObesityMicrowave Ablation

Outcome Measures

Primary Outcomes (1)

  • survival

    Percentage of participants who survived up to end time point as assessed by Kaplan-Meier

    3 years

Secondary Outcomes (4)

  • intra-hepatic metastasis

    3 years

  • extra-hepatic metastasis

    3 years

  • local tumor progression

    3 years

  • complication

    3 years

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

HCC patients are treated by ultrasound-guided percutaneous MWA

You may qualify if:

  • 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.

You may not qualify if:

  • clinical evident liver failure, such as massive ascites or hepatic encephalopathy or with a trance-like state
  • 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)
  • high intrahepatic tumor burden (tumor volume \>70% of the target liver volume or multiple tumor nodules) or high extrahepatic tumor burden
  • acute or active inflammatory and infectious lesions at any organ
  • acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, HepatocellularObesity

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver DiseasesOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Jie Yu, Dr

    Chinese PLA General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jie Yu, Dr

CONTACT

66939530yu-jie301@hotmail.com

Meng-juan Mu, BM

CONTACT

66939530mmj869900@163.com

Study Design

Study Type
observational
Observational Model
CASE CROSSOVER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 12, 2017

First Posted

March 17, 2017

Study Start

March 1, 2017

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 17, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)