Clinical trial NCT04089878: "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
Official title: "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"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Liver Cirrhoses
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2019-09-13
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility criteria: Inclusion Criteria:

* Child A and B cirrhotic patients with Gastro/lieno-renal shunt of \>8 mm.
* Covert or Overt HE
* Age 18 to 70 years

Exclusion Criteria:

* Intractable ascites
* 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

Primary outcomes:
measure: Improvement in covertHepatic Encephalopathy in both groups.
timeFrame: 1 year
Secondary outcomes:
measure: Change in ammonia level in both groups
timeFrame: 1 year
measure: Incidence of ascites in both groups
timeFrame: 1 year
measure: Incidence of acute variceal bleed in both groups.
timeFrame: 1 year
measure: Number of participants with Liver transplant or death in both groups.
timeFrame: 1 year
measure: Change in MELD (Model for End Stage Liver Disease) by >5 point improvement in both groups.
timeFrame: 6 months
measure: Change in CTP (Child-Pugh score) by 2 points improvement in both groups.
timeFrame: 6 months
measure: Changes in portal flow in both groups.
timeFrame: 1 year
measure: Number of patients with prevention of Gastro-Variceal bleed in both groups.
timeFrame: 1 year
measure: Number of patients with adverse effects of PARTO/BRTO (Balloon-occluded retrograde transvenous obliteration) in both groups.
timeFrame: 1 year
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver & Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Shiv Kumar Sarin, DM
role: PRINCIPAL_INVESTIGATOR
References: