Trials / Unknown

UnknownNCT04089878

"To Study the Impact of Balloon-occluded Retrograde Transvenous Obliteration (BRTO)/Plug Assisted Retrograde Transvenous Obliteration (PARTO) Mediated Portal Flow Modulation in Reduction of Ammonia and Improvement in Organ Volume and Functionality in Patients of Cirrhosis With LR Shunt

Status: Unknown
Phase: N/A
Study type: Interventional
Enrollment: 50 (estimated)

Sponsor: Institute of Liver and Biliary Sciences, India · Academic / Other
Sex: All
Age: 18 Years – 70 Years
Healthy volunteers: Not accepted

Summary

The informed consent will be obtained from the participants in the study. The study will be conducted on indoor patients, Department of Hepatology ILBS, New Delhi. This will be a Pilot study (sample size 25 cases in each arm) with 50% chances of each patient to randomized into each arm(1:1 randomization) . Study Population - Patients with hepatic encephalopathy with LR shunt admitted in wards/HDU (High Dependency Unit)/LC ICU(Liver Coma ICU). Study design-Randomized controlled Trial Study period- 1 year. Sample Size-Single Centre prospective RCT * Sample size- Pilot study (sample size 25 cases in each arm) * Follow up duration-6 months

Conditions

Liver Cirrhoses

Interventions

Type	Name	Description
PROCEDURE	Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration	Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration
OTHER	Standard Medical Treatment	Antibiotics, nutrition and supportive treatment

Timeline

Start date: 2019-09-14
Primary completion: 2020-09-30
Completion: 2020-09-30
First posted: 2019-09-13
Last updated: 2019-11-13

Locations

1 site across 1 country: India

Source: ClinicalTrials.gov record NCT04089878. Inclusion in this directory is not an endorsement.