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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

Primary Purpose

Liver Cirrhoses

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration
Standard Medical Treatment
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Liver Cirrhoses

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Institute of Liver & Biliary SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PARTO/BRTO + SMT

Standard Medical Treatment

Arm Description

PARTO/BRTO with SMT will be given.

Antibiotics, nutrition and supportive treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change in ammonia level in both groups
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.
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.
Number of participants with Liver transplant or death in both groups.
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.
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 .
Changes in portal flow in both groups.
Change will be measured by ICG and Doppler study tests.
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.
Number of patients with adverse effects of PARTO/BRTO (Balloon-occluded retrograde transvenous obliteration) in both groups.

Full Information

First Posted
August 28, 2019
Last Updated
November 9, 2019
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT04089878
Brief 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
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 14, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Anticipated)
Study Completion Date
September 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Cirrhoses

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PARTO/BRTO + SMT
Arm Type
Experimental
Arm Description
PARTO/BRTO with SMT will be given.
Arm Title
Standard Medical Treatment
Arm Type
Active Comparator
Arm Description
Antibiotics, nutrition and supportive treatment
Intervention Type
Procedure
Intervention Name(s)
Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration
Intervention Description
Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration
Intervention Type
Other
Intervention Name(s)
Standard Medical Treatment
Intervention Description
Antibiotics, nutrition and supportive treatment
Primary Outcome Measure Information:
Title
Improvement in covertHepatic Encephalopathy in both groups.
Description
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.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Change in ammonia level in both groups
Time Frame
1 year
Title
Incidence of ascites in both groups
Description
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.
Time Frame
1 year
Title
Incidence of acute variceal bleed in both groups.
Description
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.
Time Frame
1 year
Title
Number of participants with Liver transplant or death in both groups.
Time Frame
1 year
Title
Change in MELD (Model for End Stage Liver Disease) by >5 point improvement in both groups.
Description
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.
Time Frame
6 months
Title
Change in CTP (Child-Pugh score) by 2 points improvement in both groups.
Description
CTP- Child-Turcotte-Pugh score is ranges from 5 to 15, lowest is best and highest is worst .
Time Frame
6 months
Title
Changes in portal flow in both groups.
Description
Change will be measured by ICG and Doppler study tests.
Time Frame
1 year
Title
Number of patients with prevention of Gastro-Variceal bleed in both groups.
Description
It is a clinical outcome and it will be assessed by history and will be confirmed and managed by endoscopic procedure.
Time Frame
1 year
Title
Number of patients with adverse effects of PARTO/BRTO (Balloon-occluded retrograde transvenous obliteration) in both groups.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Shiv Kumar Sarin, DM
Phone
01146300000
Email
shivsarin@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Shiv Kumar Sarin, DM
Organizational Affiliation
Institute of Liver and Biliary Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Rakesh Kumar Jagdish, MD
Phone
01146300000
Email
dr.rkj.kapil@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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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

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