Liver Cirrhosis
Conditions
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.
Interventions
PROCEDUREIntragstric Ballooning
Intragstric Ballooning will be put.
Sponsors
Institute of Liver and Biliary Sciences, India
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in weight from baseline | 3 months |
| Change in weight reduction from baseline | 6 Months |
Secondary
| Measure | Time frame |
|---|---|
| Disappearance of esophageal varices 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. | 3 Months |
| Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups. | 3 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 |
| Improvement in liver parameters such as bilirubin in both groups | 3 Months |
| Change in hormonal levels such as Endothelin level in both groups.. | 3 Month |
| Improvement in liver parameters such as serum albumin in both groups. | 3 Months |
| Improvement liver parameters such as INR in both groups | 3 Months |
| Improvement in liver parameters such as INR in both groups. | 6 Months |
| Change in development of liver related complications | 3 Months |
| Improvement of insulin resistance in both groups. | 3 Months |
| Decreased usage of medications for diabetes mellitus in both groups. | 3 Months |
| Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups. | 3 Months |
| Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha). | 3 Months |
| Change in hormonal levels such as Ghrelin level in both groups.. | 3 Months |
| Improvement in liver parameters such as bilirubin in both groups. | 6 Months |
Countries
India
Outcome results
None listed