Liver CirrhosesNCT04089878
"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 study testing Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration and Standard Medical Treatment in people with Liver Cirrhoses, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
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) . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhoses
- What is being tested?
- Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration and Standard Medical Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 14 Sep 2019to 30 Sep 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Child A and B cirrhotic patients with Gastro/lieno-renal shunt of >8 mm.
- Covert or Overt HE
- Age 18 to 70 years
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Institute of Liver & Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070
Dr Rakesh Kumar Jagdish, MD, 01146300000, dr.rkj.kapil@gmail.com
About this study
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"
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
- Conditions
- Liver Cirrhoses
- Being tested
- Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration, Standard Medical Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliterationProcedure or surgery
Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration
Standard Medical TreatmentOther
Antibiotics, nutrition and supportive treatment
| Study group | Role | What they receive |
|---|---|---|
| PARTO/BRTO + SMT | Experimental | PARTO/BRTO with SMT will be given. Receives: Procedure: Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration |
| Standard Medical Treatment | Active comparator | Antibiotics, nutrition and supportive treatment Receives: Other: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (9)
Change in ammonia level in both groups
Measured: 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.
Measured: 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.
Measured: 1 year
Number of participants with Liver transplant or death in both groups.
Measured: 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.
Measured: 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 .
Measured: 6 months
Changes in portal flow in both groups.
Change will be measured by ICG and Doppler study tests.
Measured: 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.
Measured: 1 year
Number of patients with adverse effects of PARTO/BRTO (Balloon-occluded retrograde transvenous obliteration) in both groups.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start14 Sep 2019
- Primary completion30 Sep 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver CirrhosesStudies of the same condition, open and under way.
- More trials run by Institute of Liver and Biliary Sciences, IndiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Shiv Kumar Sarin, DM, Principal investigator, Institute of Liver and Biliary Sciences, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04089878
- Sponsor's protocol ID
- ILBS-Cirrhosis-25
- Status last verified
- Aug 2019
- First submitted
- 28 Aug 2019
- Last updated
- 13 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT04089878
- Acronym / sponsor ID
- ILBS-Cirrhosis-25
- Conditions
- Liver Cirrhoses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 14 Sep 2019 (actual)
- Primary completion
- 30 Sep 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PARTO/BRTO + SMT | Experimental | Procedure: Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliterationPARTO/BRTO with SMT will be given. |
| Standard Medical Treatment | Active comparator | Other: Standard Medical TreatmentAntibiotics, nutrition and supportive treatment |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Child A and B cirrhotic patients with Gastro/lieno-renal shunt of >8 mm.
- Covert or Overt HE
- Age 18 to 70 years
Key exclusion criteria (7 listed)
- Intractable ascites
- PVT (with 100 % block )or PV Cavernoma and splenic vein thrombosis
- High risk esophageal varices (till eradicated)
- HVPG >16 mm Hg
- HCC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliterationPlug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration | Procedure or surgery | PARTO/BRTO + SMT |
| Standard Medical TreatmentAntibiotics, nutrition and supportive treatment | Other | Standard Medical Treatment |
Primary outcome
Improvement in covertHepatic Encephalopathy in both groups.
Time frame: 1 year
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.
9 secondary outcomes
Change in ammonia level in both groups
Time frame: 1 year
Incidence of ascites in both groups
Time frame: 1 year
Incidence of acute variceal bleed in both groups.
Time frame: 1 year
Number of participants with Liver transplant or death in both groups.
Time frame: 1 year
Change in MELD (Model for End Stage Liver Disease) by >5 point improvement in both groups.
Time frame: 6 months
Change in CTP (Child-Pugh score) by 2 points improvement in both groups.
Time frame: 6 months
Changes in portal flow in both groups.
Time frame: 1 year
Number of patients with prevention of Gastro-Variceal bleed in both groups.
Time frame: 1 year
Number of patients with adverse effects of PARTO/BRTO (Balloon-occluded retrograde transvenous obliteration) in both groups.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Shiv Kumar Sarin, DM principal investigator
Institute of Liver and Biliary Sciences, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plug assisted retrograde transvenous obliteration/Balloon-occluded retrograde transvenous obliteration and Standard Medical Treatment in people with Liver Cirrhoses, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Shiv Kumar Sarin, DM (01146300000, shivsarin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in covertHepatic Encephalopathy in both groups. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Nov 2019.