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

Study Overview
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Brief Summary
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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.

Official Title
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Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics-An Observational Study

Conditions
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Liver Cirrhosis

Intervention / Treatment
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* Procedure: Intragstric Ballooning


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Intragastric Balloon<br>Intragastric Balloon will be placed for 6 months | Procedure: Intragstric Ballooning<br>* Intragstric Ballooning will be put.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in weight from baseline |  | 3 months | 
| Change in weight reduction from baseline |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in development of liver related complications |  | 3 Months | 
| Change in development of liver related complications |  | 6 Months | 
| Improvement of insulin resistance in both groups. |  | 3 Months | 
| Improvement of insulin resistance in both groups. |  | 6 Months | 
| Decreased usage of medications for diabetes mellitus in both groups. |  | 3 Months | 
| Decreased usage of medications for diabetes mellitus in both groups. |  | 6 Months | 
| Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups. |  | 3 Months | 
| Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups. |  | 6 Months | 
| Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha). |  | 3 Months | 
| Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha). |  | 6 Months | 
| Improvement in liver parameters such as serum albumin in both groups. |  | 3 Months | 
| Improvement in liver parameters such as serum albumin in both groups. |  | 6 Months | 
| Improvement liver parameters such as INR in both groups |  | 3 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 liver parameters such as bilirubin in both groups. |  | 6 Months | 
| Disappearance of esophageal varices in both groups. |  | 3 Months | 
| Disappearance of esophageal varices in both groups. |  | 6 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. |  | 3 Months | 
| Improvement in CAP (Controlled Attenuation Index) in both groups. |  | 6 Months | 
| Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups. |  | 3 Months | 
| Improvement in HVPG (Hepatic venous Pressure Gradient) 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.. |  | 3 Months | 
| Change in hormonal levels such as Adiponectin level in both groups. |  | 6 months | 
| Change in hormonal levels such as leptin level in both groups. |  | 3 Months | 
| Change in hormonal levels such as Ghrelin level in both groups.. |  | 3 Months | 
| Change in hormonal levels such as Ghrelin level in both groups.. |  | 6 Months | 
| Change in hormonal levels such as Endothelin level in both groups.. |  | 3 Month | 
| Change in hormonal levels such as Endothelin level in both groups.. |  | 6 Month |