NCT04089878

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

September 13, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

September 14, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2020

Completed
Last Updated

November 13, 2019

Status Verified

August 1, 2019

Enrollment Period

1 year

First QC Date

August 28, 2019

Last Update Submit

November 9, 2019

Conditions

Liver Cirrhoses

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (9)

  • Change in ammonia level in both groups

    1 year

  • Incidence of ascites in both groups

    1 year

  • Incidence of acute variceal bleed in both groups.

    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.

    6 months

  • +4 more secondary outcomes

Study Arms (2)

PARTO/BRTO + SMT

EXPERIMENTAL

PARTO/BRTO with SMT will be given.

Procedure: Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration

Standard Medical Treatment

ACTIVE COMPARATOR

Antibiotics, nutrition and supportive treatment

Other: Standard Medical Treatment

Interventions

Standard Medical TreatmentOTHER

Antibiotics, nutrition and supportive treatment

Standard Medical Treatment
Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliterationPROCEDURE

Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration

PARTO/BRTO + SMT

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

Study Officials

  • Dr Shiv Kumar Sarin, DM

    Institute of Liver and Biliary Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr Shiv Kumar Sarin, DM

CONTACT

01146300000shivsarin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2019

First Posted

September 13, 2019

Study Start

September 14, 2019

Primary Completion

September 30, 2020

Study Completion

September 30, 2020

Last Updated

November 13, 2019

Record last verified: 2019-08

Locations

IN(1)