CompletedNot Applicable

Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics

India56 participantsStarted 2016-08-02

Plain-language 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 also patients who undergo IGB placement as part of weight reduction policy in these group of patients and will undergo an UGI endoscopy followed by placement of intragastric balloon. Then the patients will be admitted for 2-3 days and followed up till 6 months.

Who can participate

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Change in weight from baseline

Timeframe: 3 months

Change in weight reduction from baseline

Timeframe: 6 Months

Trial details

NCT IDNCT03753438

SponsorInstitute of Liver and Biliary Sciences, India

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2020-05-31

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