Clinical trial NCT03753438: Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics
Official title: Intragastric Balloon in Compensated NASH(Non Alcoholic Steato Hepatitis) Cirrhotics-An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Cirrhosis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2018-11-27
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: NASH (Non Alcoholic SteatoHepatitis) cirrhosis.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in weight from baseline
timeFrame: 3 months
measure: Change in weight reduction from baseline
timeFrame: 6 Months
Secondary outcomes:
measure: Change in development of liver related complications
timeFrame: 3 Months
measure: Change in development of liver related complications
timeFrame: 6 Months
measure: Improvement of insulin resistance in both groups.
timeFrame: 3 Months
measure: Improvement of insulin resistance in both groups.
timeFrame: 6 Months
measure: Decreased usage of medications for diabetes mellitus in both groups.
timeFrame: 3 Months
measure: Decreased usage of medications for diabetes mellitus in both groups.
timeFrame: 6 Months
measure: Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.
timeFrame: 3 Months
measure: Decreased usage of medications for HOMA-IR (Homeostatic Model Assessment-Insulin Resistance) in both groups.
timeFrame: 6 Months
measure: Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha).
timeFrame: 3 Months
measure: Improvement of insulin resistance and decreased usage of medications for TNF-α (Tumor Necrosis Factor-Alpha).
timeFrame: 6 Months
measure: Improvement in liver parameters such as serum albumin in both groups.
timeFrame: 3 Months
measure: Improvement in liver parameters such as serum albumin in both groups.
timeFrame: 6 Months
measure: Improvement liver parameters such as INR in both groups
timeFrame: 3 Months
measure: Improvement in liver parameters such as INR in both groups.
timeFrame: 6 Months
measure: Improvement in liver parameters such as bilirubin in both groups
timeFrame: 3 Months
measure: Improvement in liver parameters such as bilirubin in both groups.
timeFrame: 6 Months
measure: Disappearance of esophageal varices in both groups.
timeFrame: 3 Months
measure: Disappearance of esophageal varices in both groups.
timeFrame: 6 Months
measure: Improvement in LSM (liver stiffness on fibroscan) in both groups
timeFrame: 3 Months
measure: Improvement in LSM (liver stiffness on fibroscan) in both groups.
timeFrame: 6 Months
measure: Improvement in CAP (Controlled Attenuation Index) in both groups.
timeFrame: 3 Months
measure: Improvement in CAP (Controlled Attenuation Index) in both groups.
timeFrame: 6 Months
measure: Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.
timeFrame: 3 Months
measure: Improvement in HVPG (Hepatic venous Pressure Gradient) in both groups.
timeFrame: 6 Months
measure: Improvement in liver histology post completion of study in both groups.
timeFrame: 6 Months
measure: Change in hormonal levels such as Adiponectin level in both groups..
timeFrame: 3 Months
measure: Change in hormonal levels such as Adiponectin level in both groups.
timeFrame: 6 months
measure: Change in hormonal levels such as leptin level in both groups.
timeFrame: 3 Months
measure: Change in hormonal levels such as Ghrelin level in both groups..
timeFrame: 3 Months
measure: Change in hormonal levels such as Ghrelin level in both groups..
timeFrame: 6 Months
measure: Change in hormonal levels such as Endothelin level in both groups..
timeFrame: 3 Month
measure: Change in hormonal levels such as Endothelin level in both groups..
timeFrame: 6 Month
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver & Biliary Sciences
name: Shiv Kumar Sarin, DM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. 2023 Mar;68(3):1035-1041. doi: 10.1007/s10620-022-07596-4. Epub 2022 Jun 28.