"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
NCT ID: NCT04089878
Last Updated: 2019-11-13
Study Results
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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UNKNOWN
NA
50 participants
INTERVENTIONAL
2019-09-14
2020-09-30
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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PARTO/BRTO + SMT
PARTO/BRTO with SMT will be given.
Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration
Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration
Standard Medical Treatment
Antibiotics, nutrition and supportive treatment
Standard Medical Treatment
Antibiotics, nutrition and supportive treatment
Interventions
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Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration
Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration
Standard Medical Treatment
Antibiotics, nutrition and supportive treatment
Eligibility Criteria
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Inclusion Criteria
* Covert or Overt HE
* Age 18 to 70 years
Exclusion Criteria
* PVT (with 100 % block )or PV Cavernoma and splenic vein thrombosis
* High risk esophageal varices (till eradicated)
* HVPG \>16 mm Hg
* HCC
* Pregnancy and lactation
* Refusal to participate in the study
18 Years
70 Years
ALL
No
Sponsors
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Institute of Liver and Biliary Sciences, India
OTHER
Responsible Party
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Principal Investigators
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Dr Shiv Kumar Sarin, DM
Role: PRINCIPAL_INVESTIGATOR
Institute of Liver and Biliary Sciences
Locations
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Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ILBS-Cirrhosis-25
Identifier Type: -
Identifier Source: org_study_id
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