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

Institute of Liver and Biliary Sciences, India56 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Liver Cirrhosis

Interventions

Intragstric BallooningPROCEDURE

Intragstric Ballooning will be put.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

Change in weight from baseline

Time frame: 3 months

Change in weight reduction from baseline

Time frame: 6 Months

Secondary Outcomes

Change in development of liver related complications

Time frame: 3 Months

Change in development of liver related complications

Time frame: 6 Months

Improvement of insulin resistance in both groups.

Time frame: 3 Months

Improvement of insulin resistance in both groups.

Time frame: 6 Months

Decreased usage of medications for diabetes mellitus in both groups.

Time frame: 3 Months

Decreased usage of medications for diabetes mellitus in both groups.

Time frame: 6 Months

Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.

Time frame: 3 Months

Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.

Time frame: 6 Months

Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha).

Time frame: 3 Months

Data from ClinicalTrials.gov

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Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha).

Time frame: 6 Months

Improvement in liver parameters such as serum albumin in both groups.

Time frame: 3 Months

Improvement in liver parameters such as serum albumin in both groups.

Time frame: 6 Months

Improvement liver parameters such as INR in both groups

Time frame: 3 Months

Improvement in liver parameters such as INR in both groups.

Time frame: 6 Months

Improvement in liver parameters such as bilirubin in both groups

Time frame: 3 Months

Improvement in liver parameters such as bilirubin in both groups.

Time frame: 6 Months

Disappearance of esophageal varices in both groups.

Time frame: 3 Months

Disappearance of esophageal varices in both groups.

Time frame: 6 Months

Improvement in LSM (liver stiffness on fibroscan) in both groups

Time frame: 3 Months

Improvement in LSM (liver stiffness on fibroscan) in both groups.

Time frame: 6 Months

Improvement in CAP (Controlled Attenuation Index) in both groups.

Time frame: 3 Months

Improvement in CAP (Controlled Attenuation Index) in both groups.

Time frame: 6 Months

Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.

Time frame: 3 Months

Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.

Time frame: 6 Months

Improvement in liver histology post completion of study in both groups.

Time frame: 6 Months

Change in hormonal levels such as Adiponectin level in both groups..

Time frame: 3 Months

Change in hormonal levels such as Adiponectin level in both groups.

Time frame: 6 months

Change in hormonal levels such as leptin level in both groups.

Time frame: 3 Months

Change in hormonal levels such as Ghrelin level in both groups..

Time frame: 3 Months

Change in hormonal levels such as Ghrelin level in both groups..

Time frame: 6 Months

Change in hormonal levels such as Endothelin level in both groups..

Time frame: 3 Month

Change in hormonal levels such as Endothelin level in both groups..

Time frame: 6 Month