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Balloon-occluded Retrograde Transvenous Obliteration (procedure) in liver cirrhosis.

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-A randomized trial.ImPARTO Trial.

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/09/021237
Enrollment
50
Registered
2019-09-13
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: PARTO/BRTO with Standard Medical Care: Balloon-occluded retrograde transvenous obliteration (BRTO) is a well-accepted method of treating gastric variceal bleeding (GVB) in the setting

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1) Child A and B cirrhotic patients with Gastro/lieno-renal shunt of >8 mm. 2) Covert or Overt HE 3) Age 18 to 70 years

Exclusion criteria

Exclusion criteria: 1)Intractable ascites 2) PVT (with 100 % block )or PV Cavernoma and splenic vein thrombosis 3) High risk esophageal varices (till eradicated) 4) HVPG >16 mm Hg 5) Hepatocellular Carcinoma 6) Pregnancy and lactation 7) Refusal to participate in the study

Design outcomes

Primary

MeasureTime frame
Improvement in covert/overt Hepatic Encephalopathy in both groups.Timepoint: 1 year—

Secondary

MeasureTime frame
Adverse effects of PARTO/BRTO (Balloon-occluded retrograde transvenous obliteration) in both groups.Timepoint: 1 year;Changes in portal flow (ICG and Doppler study) in both groups.Timepoint: 1 year;Improvement in Child-Pugh score by 2 points in both groups.Timepoint: 6 months;Improvement in MELD more than 5 in both groups.Timepoint: 6 months;Liver transplant or Death in both groups.Timepoint: 1 year;New onset AVB or Ascites in both groupsTimepoint: 1 year;Prevention of Gastro-Variceal bleed in both groups.Timepoint: 1 year;Reduction in ammonia level in both groupsTimepoint: 1 year—

Countries

India

Contacts

Public ContactDr Shiv Kumar Sarin

Institute of Liver and Biliary Sciences

shivsarin@gmail.com01146300000

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026