Liver CirrhosesNCT04013074
Efficacy and Safety of Early TIPS (Transjugular Intrahepatic Portosystemic Shunts) in the Management of Cirrhosis With Recurrent Ascites.
A study testing Transjugular Intrahepatic Portosystemic Shunt 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
All consecutive patients with cirrhosis of liver who satisfy the criteria will be included and will be evaluated clinically along with all routine investigations and standard medical therapy will be continued among these patients. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Cirrhoses
- What is being tested?
- Transjugular Intrahepatic Portosystemic Shunt and Standard Medical Treatment
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIndia
- Study dates
- 9 Jul 2019to 31 Jul 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Liver Cirrhotics between 18-60 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan \& imaging)
- Recurrent ascites (2 or more large volume paracentesis in last 3 month) on maximal tolerated diuretic dose.
- Diuretic intractable ascites ( developing AKI/ hyponatremia (Na-<130 , hypo/ hyperkalemia (<3.5 , >5.5), who will respond to withdrawal of diuretics
- HVPG >12 mm Hg
- CTP ≥ 7-12
- Patient is willing and able to comply with all study protocol requirements, including specified follow-up and testing.
Who cannot join
- Hepatic or extra hepatic Malignancy-HCC, PVT
- MELD (Model for End Stage Liver Disease) > 18
- Post TIPS (Transjugular Intrahepatic Portosystemic Shunt), Shunt surgery
- LVP (Large Volume Paracentesis) >3/month
- Acute kidney injury (Sr.Cr>2mg/dl)
- 5) CKD (Chronic Kidney Injury) 6) Previous hepatic encephalopathy 7) Acute on chronic liver failure 8) Active infection 9) Active alcohol intake 10) Left Ventricular systolic dysfunction/ overt CCM 11) PPH (Portopulmonary Hypertension) 12) Pt on mechanical ventilation 13) Patient in ICU/ any acute illness 14) Pregnant lady 15) SBP (Spontaneous bacterial Peritonitis)
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 Vinay Kumar, MD, 01146300000, drvinaybr@gmail.com
About this study
All consecutive patients with cirrhosis of liver who satisfy the criteria will be included and will be evaluated clinically along with all routine investigations and standard medical therapy will be continued among these patients. The patients between 18-60 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan \& imaging.) , with ascites and HVPG (Hepatic Venous Pressure Gradient) >12, with 2 or more large volume paracentesis in last 3 month . CTP ≥ 7-13 will be considered for the study.
At baseline, a complete history of the cause of cirrhosis of liver with clinical and physical examination, a record of demographic profile, standard of care biochemical investigations would be done.
Read more
In this study patients who satisfy the inclusion and exclusion criteria as mentioned below will be enrolled to receive either standard medical therapy with Large volume paracentesis and albumin infusion or to be randomised to receive TIPS (Transjugular Intrahepatic Portosystemic Shunt).
The patients in group A will be given standard medical therapy only included as per requirement nutritional therapy (high calorie intake- 2400 Kcal/ day) as and when required Large Volume Paracentesis (LVP) and albumin infusion and diuretics.
- Conditions
- Liver Cirrhoses
- Being tested
- Transjugular Intrahepatic Portosystemic Shunt, Standard Medical Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transjugular Intrahepatic Portosystemic ShuntProcedure or surgery
Transjugular Intrahepatic Portosystemic Shunt
Standard Medical TreatmentOther
Standard Medical Therapy only included as per requirement nutritional therapy (high calorie intake- 2400 Kcal/ day) as and when required LVP and albumin infusion and diuretics.
| Study group | Role | What they receive |
|---|---|---|
| TIPS+Standard Medical Treatment | Experimental | TIPS along with standard medical therapy only included as per requirement nutritional therapy (high calorie intake- 2400 Kcal/ day) as and when required LVP and albumin infusion and diuretics. Receives: Procedure: Transjugular Intrahepatic Portosystemic Shunt; Other: Standard Medical Treatment |
| Standard Medical Treatment | Active comparator | standard medical therapy only included as per requirement nutritional therapy (high calorie intake- 2400 Kcal/ day) as and when required LVP and albumin infusion and diuretics. Receives: Other: Standard Medical Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transplant free survival in both groups
Measured: 1 year
Secondary outcomes (8)
Overall survival in both groups
Measured: 1 year
Reduction in HVPG from baseline in both groups
Measured: 6 month
Reduction in HVPG from baseline in both groups
Measured: 12 month
Incidence of Acute Kidney Injury new complications in both groups
Measured: 1 year
Incidence of Spontaneous bacterial Peritonitis in both groups
Measured: 1 year
Incidence of Hepatic Encephalopathy in both groups
Measured: 1 year
Incidence of Bleeding in both groups
Measured: 1 year
Incidence of hyponatremia 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 posted9 Jul 2019
- Study start9 Jul 2019
- Primary completion31 Jul 2020 (estimated)
- Study completion31 Jul 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Liver and Biliary Sciences, India
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04013074
- Sponsor's protocol ID
- ILBS-Cirrhosis-23
- Status last verified
- Jul 2019
- First submitted
- 7 Jul 2019
- Last updated
- 28 Aug 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 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Early TIPS (Transjugular Intrahepatic Portosystemic Shunts) in the Management of Cirrhosis With Recurrent Ascites.
- ClinicalTrials.gov ID
- NCT04013074
- Acronym / sponsor ID
- ILBS-Cirrhosis-23
- Conditions
- Liver Cirrhoses
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Institute of Liver and Biliary Sciences, IndiaUniversity, hospital or other
- Study start
- 9 Jul 2019 (actual)
- Primary completion
- 31 Jul 2020 (estimated)
- Study completion
- 31 Jul 2020 (estimated)
- First posted
- 9 Jul 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.
All consecutive patients with cirrhosis of liver who satisfy the criteria will be included and will be evaluated clinically along with all routine investigations and standard medical therapy will be continued among these patients. The patients between 18-60 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan \& imaging.) , with ascites and HVPG (Hepatic Venous Pressure Gradient) >12, with 2 or more large volume paracentesis in last 3 month . CTP ≥ 7-13 will be considered for the study.
At baseline, a complete history of the cause of cirrhosis of liver with clinical and physical examination, a record of demographic profile, standard of care biochemical investigations would be done.
In this study patients who satisfy the inclusion and exclusion criteria as mentioned below will be enrolled to receive either standard medical therapy with Large volume paracentesis and albumin infusion or to be randomised to receive TIPS (Transjugular Intrahepatic Portosystemic Shunt).
The patients in group A will be given standard medical therapy only included as per requirement nutritional therapy (high calorie intake- 2400 Kcal/ day) as and when required Large Volume Paracentesis (LVP) and albumin infusion and diuretics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIPS+Standard Medical Treatment | Experimental | Procedure: Transjugular Intrahepatic Portosystemic Shunt, Other: Standard Medical TreatmentTIPS along with standard medical therapy only included as per requirement nutritional therapy (high calorie intake- 2400 Kcal/ day) as and when required LVP and albumin infusion and diuretics. |
| Standard Medical Treatment | Active comparator | Other: Standard Medical Treatmentstandard medical therapy only included as per requirement nutritional therapy (high calorie intake- 2400 Kcal/ day) as and when required LVP and albumin infusion and diuretics. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Liver Cirrhotics between 18-60 yrs of age (cirrhosis diagnosed on the basis of clinical, biochemical, fibroscan \& imaging)
- Recurrent ascites (2 or more large volume paracentesis in last 3 month) on maximal tolerated diuretic dose.
- Diuretic intractable ascites ( developing AKI/ hyponatremia (Na-<130 , hypo/ hyperkalemia (<3.5 , >5.5), who will respond to withdrawal of diuretics
- HVPG >12 mm Hg
- CTP ≥ 7-12
Key exclusion criteria (6 listed)
- Hepatic or extra hepatic Malignancy-HCC, PVT
- MELD (Model for End Stage Liver Disease) > 18
- Post TIPS (Transjugular Intrahepatic Portosystemic Shunt), Shunt surgery
- LVP (Large Volume Paracentesis) >3/month
- Acute kidney injury (Sr.Cr>2mg/dl)
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 |
|---|---|---|
| Transjugular Intrahepatic Portosystemic ShuntTransjugular Intrahepatic Portosystemic Shunt | Procedure or surgery | TIPS+Standard Medical Treatment |
| Standard Medical TreatmentStandard Medical Therapy only included as per requirement nutritional therapy (high calorie intake- 2400 Kcal/ day) as and when required LVP and albumin infusion and diuretics. | Other | Standard Medical Treatment, TIPS+Standard Medical Treatment |
Primary outcome
Transplant free survival in both groups
Time frame: 1 year
8 secondary outcomes
Overall survival in both groups
Time frame: 1 year
Reduction in HVPG from baseline in both groups
Time frame: 6 month
Reduction in HVPG from baseline in both groups
Time frame: 12 month
Incidence of Acute Kidney Injury new complications in both groups
Time frame: 1 year
Incidence of Spontaneous bacterial Peritonitis in both groups
Time frame: 1 year
Incidence of Hepatic Encephalopathy in both groups
Time frame: 1 year
Incidence of Bleeding in both groups
Time frame: 1 year
Incidence of hyponatremia 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 28 Aug 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transjugular Intrahepatic Portosystemic Shunt 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 6 inclusion and 6 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 28 Aug 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 Vinay Kumar, MD (01146300000, drvinaybr@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplant free survival 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 28 Aug 2019.