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

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

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 Overview

• Status: Completed
• Conditions: Liver Cirrhosis
• Intervention / Treatment: Procedure: Intragstric Ballooning

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Institute of Liver & Biliary Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

NASH (Non Alcoholic SteatoHepatitis) cirrhosis.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Intragastric Balloon; Intragastric Balloon will be placed for 6 months	Procedure: Intragstric Ballooning; Intragstric Ballooning will be put.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Shiv Kumar Sarin, DM, Institute of Liver & Biliary Sciences

Publications and helpful links

General Publications

• Vijayaraghavan R, Sarin SK, Bharadwaj A, Anand L, Maiwall R, Choudhury A, Benjamin J, Kanal U, Jamwal KD. Intragastric Balloon in Obese Compensated Nonalcoholic Steatohepatitis Cirrhosis Patients Is Safe and Achieves Significant Weight Reduction at 6-Months. Dig Dis Sci. 2022 Jun 28. doi: 10.1007/s10620-022-07596-4. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2016
• Primary Completion (Actual): May 31, 2020
• Study Completion (Actual): May 31, 2020

Study Registration Dates

• First Submitted: October 17, 2018
• First Submitted That Met QC Criteria: November 21, 2018
• First Posted (Actual): November 27, 2018

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Fatty Liver; Liver Cirrhosis; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: ILBS-NASH-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No