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

Liver Cirrhosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03753438
• Other study ID #: ILBS-NASH-04
• Status: Completed
• Start date: August 2, 2016
• Est. completion date: May 31, 2020

Study information

• Verified date: June 2021
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fatty Liver
• Liver Cirrhosis
• Non-alcoholic Fatty Liver Disease

Intervention

Procedure:
• Intragstric Ballooning
Intragstric Ballooning will be put.

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in weight from baseline		3 months
Primary	Change in weight reduction from baseline		6 Months
Secondary	Change in development of liver related complications		3 Months
Secondary	Change in development of liver related complications		6 Months
Secondary	Improvement of insulin resistance in both groups.		3 Months
Secondary	Improvement of insulin resistance in both groups.		6 Months
Secondary	Decreased usage of medications for diabetes mellitus in both groups.		3 Months
Secondary	Decreased usage of medications for diabetes mellitus in both groups.		6 Months
Secondary	Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.		3 Months
Secondary	Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.		6 Months
Secondary	Improvement of insulin resistance and decreased usage of medications for TNF-a (Tumor Necrosis Factor-Alpha).		3 Months
Secondary	Improvement of insulin resistance and decreased usage of medications for TNF-a (Tumor Necrosis Factor-Alpha).		6 Months
Secondary	Improvement in liver parameters such as serum albumin in both groups.		3 Months
Secondary	Improvement in liver parameters such as serum albumin in both groups.		6 Months
Secondary	Improvement liver parameters such as INR in both groups		3 Months
Secondary	Improvement in liver parameters such as INR in both groups.		6 Months
Secondary	Improvement in liver parameters such as bilirubin in both groups		3 Months
Secondary	Improvement in liver parameters such as bilirubin in both groups.		6 Months
Secondary	Disappearance of esophageal varices in both groups.		3 Months
Secondary	Disappearance of esophageal varices in both groups.		6 Months
Secondary	Improvement in LSM (liver stiffness on fibroscan) in both groups		3 Months
Secondary	Improvement in LSM (liver stiffness on fibroscan) in both groups.		6 Months
Secondary	Improvement in CAP (Controlled Attenuation Index) in both groups.		3 Months
Secondary	Improvement in CAP (Controlled Attenuation Index) in both groups.		6 Months
Secondary	Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.		3 Months
Secondary	Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.		6 Months
Secondary	Improvement in liver histology post completion of study in both groups.		6 Months
Secondary	Change in hormonal levels such as Adiponectin level in both groups..		3 Months
Secondary	Change in hormonal levels such as Adiponectin level in both groups.		6 months
Secondary	Change in hormonal levels such as leptin level in both groups.		3 Months
Secondary	Change in hormonal levels such as Ghrelin level in both groups..		3 Months
Secondary	Change in hormonal levels such as Ghrelin level in both groups..		6 Months
Secondary	Change in hormonal levels such as Endothelin level in both groups..		3 Month
Secondary	Change in hormonal levels such as Endothelin level in both groups..		6 Month