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"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

NCT04089878 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2019-11-13

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Institute of Liver and Biliary Sciences, India

    lead OTHER

Principal Investigators

  • Dr Shiv Kumar Sarin, DM · Institute of Liver and Biliary Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-14
Primary Completion
2020-09-30
Completion
2020-09-30

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04089878 on ClinicalTrials.gov