"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

"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"

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

Study Overview

• Status: Unknown
• Conditions: Liver Cirrhoses
• Intervention / Treatment: Procedure: Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration; Other: Standard Medical Treatment

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Delhi
    • New Delhi, Delhi, India, 110070
      • Recruiting
      • Institute of Liver & Biliary Sciences
      • Contact: Dr Rakesh Kumar Jagdish, MD; Phone Number: 01146300000; Email: dr.rkj.kapil@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: PARTO/BRTO + SMT; PARTO/BRTO with SMT will be given.	Procedure: Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration; Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration
ACTIVE_COMPARATOR: Standard Medical Treatment; Antibiotics, nutrition and supportive treatment	Other: Standard Medical Treatment; Antibiotics, nutrition and supportive treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in covertHepatic Encephalopathy in both groups.	Covert HE or overt HE will be analysed using clinical examination(west haven grading), specialised tests like stroop test, CFF(critical flicker frequency) or in rare cases EEG can be done.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ammonia level in both groups		1 year
Incidence of ascites in both groups	Acute variceal bleed (AVB) - will be estimated by history of hematemesis, melena, and AVB will be confirm by endoscopy if these clinical history present. It can be oesophageal variceal or gastric variceal bleed as per sarin's classification, which is confirmed and managed with endoscopy procedure. AVB is defined as a bleed in a known or suspected case of PHT, with the presence of hematemesis within 24 h of presentation, and/or ongoing melena, with last melanic stool within last 24 h. The time frame for the AVB episode is 48 h. AVB is further classified as active or inactive at the time of endoscopy. BRTO/PARTO is technically feasible, safe, and effective for gastric variceal haemorrhage in patients with portal hypertension.	1 year
Incidence of acute variceal bleed in both groups.	Acute variceal bleed (AVB) - will be estimated by history of hematemesis, melena, and AVB will be confirm by endoscopy if these clinical history present. It can be oesophageal variceal or gastric variceal bleed as per sarin's classification, which is confirmed and managed with endoscopy procedure. AVB is defined as a bleed in a known or suspected case of PHT, with the presence of hematemesis within 24 h of presentation, and/or ongoing melena, with last melanic stool within last 24 h. The time frame for the AVB episode is 48 h. AVB is further classified as active or inactive at the time of endoscopy. BRTO/PARTO is technically feasible, safe, and effective for gastric variceal haemorrhage in patients with portal hypertension.	1 year
Number of participants with Liver transplant or death in both groups.		1 year
Change in MELD (Model for End Stage Liver Disease) by >5 point improvement in both groups.	MELD: A disease severity scoring system for adults with liver disease, designed to improve the organ allocation in transplantation based on the severity of liver disease rather than the length of time on the waiting list.A MELD score is a number that ranges from 6 to 40, based on lab tests.	6 months
Change in CTP (Child-Pugh score) by 2 points improvement in both groups.	CTP- Child-Turcotte-Pugh score is ranges from 5 to 15, lowest is best and highest is worst .	6 months
Changes in portal flow in both groups.	Change will be measured by ICG and Doppler study tests.	1 year
Number of patients with prevention of Gastro-Variceal bleed in both groups.	It is a clinical outcome and it will be assessed by history and will be confirmed and managed by endoscopic procedure.	1 year
Number of patients with adverse effects of PARTO/BRTO (Balloon-occluded retrograde transvenous obliteration) in both groups.		1 year

Collaborators and Investigators

• Sponsor: Institute of Liver and Biliary Sciences, India
• Investigators: Principal Investigator: Dr Shiv Kumar Sarin, DM, Institute of Liver and Biliary Sciences

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2019
• Primary Completion (ANTICIPATED): September 30, 2020
• Study Completion (ANTICIPATED): September 30, 2020

Study Registration Dates

• First Submitted: August 28, 2019
• First Submitted That Met QC Criteria: September 12, 2019
• First Posted (ACTUAL): September 13, 2019

Study Record Updates

• Last Update Posted (ACTUAL): November 13, 2019
• Last Update Submitted That Met QC Criteria: November 9, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Liver Diseases; Fibrosis; Liver Cirrhosis
• Other Study ID Numbers: ILBS-Cirrhosis-25

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No