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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-08-02

Study Completion Date

2020-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Liver Cirrhosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Intragastric Balloon

Intragastric Balloon will be placed for 6 months

Intragstric Ballooning

Intervention Type PROCEDURE

Intragstric Ballooning will be put.

Interventions

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Intragstric Ballooning

Intragstric Ballooning will be put.

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No