Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics
Completed
- Conditions
- Liver Cirrhosis
- Interventions
- Procedure: Intragstric Ballooning
- Registration Number
- NCT03753438
- Lead Sponsor
- Institute of Liver and Biliary Sciences, India
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intragastric Balloon Intragstric Ballooning Intragastric Balloon will be placed for 6 months
- Primary Outcome Measures
Name Time Method Change in weight from baseline 3 months Change in weight reduction from baseline 6 Months
- Secondary Outcome Measures
Name Time Method Improvement in liver parameters such as serum albumin in both groups. 6 Months Change in development of liver related complications 6 Months Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha). 6 Months Improvement of insulin resistance in both groups. 6 Months Decreased usage of medications for diabetes mellitus in both groups. 6 Months Improvement liver parameters such as INR in both groups 3 Months Improvement in liver parameters such as bilirubin in both groups. 6 Months Change in hormonal levels such as Endothelin level in both groups.. 6 Month Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups. 6 Months Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups. 6 Months Change in hormonal levels such as Adiponectin level in both groups.. 3 Months Change in hormonal levels such as leptin level in both groups. 3 Months Disappearance of esophageal varices in both groups. 6 Months Improvement in liver parameters such as INR in both groups. 6 Months Improvement in liver parameters such as bilirubin in both groups 3 Months Improvement in LSM (liver stiffness on fibroscan) in both groups 3 Months Improvement in LSM (liver stiffness on fibroscan) in both groups. 6 Months Improvement in CAP (Controlled Attenuation Index) in both groups. 6 Months Improvement in liver histology post completion of study in both groups. 6 Months Change in hormonal levels such as Adiponectin level in both groups. 6 months Change in hormonal levels such as Ghrelin level in both groups.. 6 Months
Trial Locations
- Locations (1)
Institute of Liver & Biliary Sciences
🇮🇳New Delhi, Delhi, India