Status:
COMPLETED
Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics
Lead Sponsor:
Institute of Liver and Biliary Sciences, India
Conditions:
Liver Cirrhosis
Eligibility:
All Genders
18-65 years
Brief Summary
The study will be conducted in department of Hepatology at ILBS, the patients will be recruited from the OPD or IPD . The obese cirrhotic patients with NASH will be observed for standard of care and a...
Eligibility Criteria
Inclusion
- Adult patients between 18 and 65 years
- NASH (Non Alcoholic SteatoHepatitis) cirrhosis
- BMI \> 30 and failure to control weight despite full dietary and life style modifications.
- Compensated : CTP 6 \& 7 without any evidence of decompensation in form of Hepatic encephalopathy, ascites, GI bleed or prolonged jaundice.
- Small varices: Grade I varices
Exclusion
- Alcoholic liver disease
- Advanced liver disease with ascites, hepatic encephalopathy
- Other liver diseases such as chronic hepatitis B, chronic hepatitis C, Wilsons' disease, Hemochromatosis, glycogen storage diseases etc.
- Pregnancy
- Unwilling patients
- Large varices
- Past h/o GI bleed
- Hiatus hernia
- Gastric ulcer
- Severe esophagitis (Grade B and above)
- Severe PHG or gastric erythema
Key Trial Info
Start Date :
August 2 2016
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 31 2020
Estimated Enrollment :
56 Patients enrolled
Trial Details
Trial ID
NCT03753438
Start Date
August 2 2016
End Date
May 31 2020
Last Update
June 23 2021
Active Locations (1)
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1
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India, 110070