"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

Liver Cirrhoses Clinical Trial

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"

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04089878
• Other study ID #: ILBS-Cirrhosis-25
• Status: Recruiting
• Phase: N/A
• Start date: September 14, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: August 2019
• Source: Institute of Liver and Biliary Sciences, India
• Contact: Dr Shiv Kumar Sarin, DM
• Phone: 01146300000
• Email: shivsarin[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhoses
• Liver Cirrhosis

Intervention

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

Other:
• Standard Medical Treatment
Antibiotics, nutrition and supportive treatment

Locations

Country	Name	City	State
India	Institute of Liver & Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in ammonia level in both groups		1 year
Secondary	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
Secondary	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
Secondary	Number of participants with Liver transplant or death in both groups.		1 year
Secondary	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
Secondary	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
Secondary	Changes in portal flow in both groups.	Change will be measured by ICG and Doppler study tests.	1 year
Secondary	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
Secondary	Number of patients with adverse effects of PARTO/BRTO (Balloon-occluded retrograde transvenous obliteration) in both groups.		1 year