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A multicenter clinical study on the comparison of acoustic attenuation parameter using FibroTouch with liver biopsy for the steatosis diagnosis

A multicenter clinical study on the comparison of acoustic attenuation parameter using FibroTouch with liver biopsy for the steatosis diagnosis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-DDT-14004638
Enrollment
Unknown
Registered
2014-03-28
Start date
2014-05-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

fatty liver

Interventions

Gold Standard:
Index test:

Sponsors

Shanghai First People's hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.patients between the 18 to 65 years of age, non-limited gender;2.Within two weeks of the FibroTouch checkup, there are requested liver biopsy histological specimens;Using the liver biopsy needle of 16G or 14CT,Puncture and remove more than two centimeters long liver tissue (Including at least eleven portal areas, no fewer than six complete portal area and more than one centimeters minimum length of specimen).3.Willing and able to abide and complete all study procedures.4.Willing and can offer written informed consent form by the patient or patient’s the legal guardian.

Exclusion criteria

Exclusion criteria: 1.The people who may have the active or suspected cancer or history of malignant tumor by evidence, as well as the people who have the liver malignant tumors injury, cann’t participate in this study. 2.The people who have the history of a high alcohol intake,40 gram/day for male and 40 gram/day for female((alcohol intake(g) = the amount of drinking(ml)×alcohol content%(v/v)×0.8(g/ml), 1g alcohol is the equal of 25-40ml beer, 8-10ml yellow rice wine, 5-12ml wine, 3-7ml health care wine or white spirit)), or abuse drug by evidence. 3.Alcoholic liver disease, hepatitis C 4.Pregnant or lactating women, the people who have a pregnant plan and don't want to birth control in the study period. 5.the peoplewith history of organ transplantation or existing functional graft (except the cornea or hair graft). 6.The people with wound on the right upper abdomen recently. 7.The people who have the historyof serious illness,or other evidence shown that the patient have serious illness or don't fit to participate in the experiment. 8.The people who participate in other clinical research at the same time.

Design outcomes

Primary

MeasureTime frame
Measurement parameters of ultrasonic attenuation;

Countries

China

Contacts

Public Contactlungen Lu
lungenlu1965@163.com021-63240090

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026