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

Institute of Liver and Biliary Sciences, India

Status: Completed

Conditions: Liver Cirrhosis

Treatments: Procedure: Intragstric Ballooning

Study type: Observational

Funder types: Other

Identifiers

NCT03753438

ILBS-NASH-04

Details and patient eligibility

About

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.

Enrollment: 56 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

56 participants in 1 patient group

Intragastric Balloon

Description:

Intragastric Balloon will be placed for 6 months

Treatment:

Procedure: Intragstric Ballooning