Liver CirrhosesNCT03827681
To Study the Efficacy and Safety of TIPS (Trans Intrahepatic Portosystemic Shunt) Versus Self Expanding Metallic Stent (SEMS) in the Management of Refractory Variceal Bleed in Cirrhotics.
A study testing Trans Intrahepatic Portosystemic Shunt, Self Expanding Metallic Stent and Vasoactive Agent in people with Liver Cirrhoses, run by Institute of Liver and Biliary Sciences, India at 1 site in India.
Trial summary
A total of 50 patients will be enrolled and will be randomized into either Group A(TIPS) or Group B (SEMS). Primary end point of the study will be to compare efficacy of TIPS versus SEMS for survival at 6 week or Early re Bleed. 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?
- Trans Intrahepatic Portosystemic Shunt, Self Expanding Metallic Stent and Vasoactive Agent
- 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
- 6 Feb 2019to 30 Jun 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
- Consecutive patients of cirrhosis aged 18-70 years presenting with acute variceal Bleeding, who on endoscopy fail to control bleed or rebleeds within 5 days will be randomized.
Who cannot join
- Bleeding from non-variceal source
- Coagulopathy related bleed
- Bleeding from Gastric varices
- Any malignancy including HCC
- Main Portal vein thrombosis
- Patients in refractory shock
Show all 13Show fewer
- Patients with severe cardiopulmonary disease
- Grade 4 Hepatic encephalopathy
- MELD > 25
- Multiorgan failure
- Active sepsis
- Pregnancy
- Failure to give consent
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 Shushrut Singh, MD
About this study
Official title: A Randomised Controlled Trial to Study the Efficacy and Safety of TIPS (Trans Intrahepatic Portosystemic Shunt) Versus Self Expanding Metallic Stent (SEMS) in the Management of Refractory Variceal Bleed in Cirrhotics.
A total of 50 patients will be enrolled and will be randomized into either Group A(TIPS) or Group B (SEMS).
Primary end point of the study will be to compare efficacy of TIPS versus SEMS for survival at 6 week or Early re Bleed. All enrolled patients will also undergo HVPG measurement at baseline to stratify risk of failure to control bleed or early re-bleed.
Patient will be monitored for 5 days for re bleed, complications of therapy, worsening of Liver function tests and scores and efficacy of either treatment modality over other. Patient will be followed for 6 weeks to see for the primary end point.
- Conditions
- Liver Cirrhoses
- Being tested
- Trans Intrahepatic Portosystemic Shunt, Self Expanding Metallic Stent, Vasoactive Agent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trans Intrahepatic Portosystemic ShuntProcedure or surgery
- The most common approach is through the right internal jugular approach.
- After infiltrating the puncture site with 2% lignocaine and puncturing the vein a guide wire is advanced into the IVC followed by a 9F/10F vascular sheath.
- A wedged venogram is performed with a peripherally placed hepatic vein catheter, which may identify a portion of the portal vein to facilitate subsequent puncture.'
- A stiff guide wire is then passed through the catheter and the vascular sheath is advanced into the right hepatic vein. With the vascular sheath in place a rigid needle with 15-20 degrees of distal angulation is advanced over the guide wire and through the vascular sheath to enter the hepatic vein.
Self Expanding Metallic StentProcedure or surgery
- At upper endoscopy, a 0.35 Superstiff radiological guidewire with a soft tip (supplied with the stent insertion kit) is delivered into the stomach under direct vision and the endoscope is removed.
- The stent delivery device is then advanced over the guidewire into the stomach, and the distal portion of the stent delivery system is withdrawn to allow inflation of the gastric balloon.
- The gastric balloon is then inflated with 100 mL of air, and the whole delivery system is withdrawn until resistance is felt, which signifies that the balloon is impacting at the cardia, thus anchoring the distal end of the stent during deployment.
- After stent deployment, the gastric balloon is deflated and the stent delivery system is withdrawn. The stent is then examined endoscopically. When deployed, the stent is 135 mm long and 25 mm wide.
Vasoactive AgentDrug
Vasoactive Agent
| Study group | Role | What they receive |
|---|---|---|
| TIPS + Vasoactive Drug | Experimental | Not described Receives: Procedure: Trans Intrahepatic Portosystemic Shunt; Drug: Vasoactive Agent |
| SEMS + Vasoactive Drug | Active comparator | Not described Receives: Procedure: Self Expanding Metallic Stent; Drug: Vasoactive Agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival in both groups
Measured: 6 weeks
Secondary outcomes (5)
Re-bleeding in both groups for 5 days from end of therapy
Measured: 5 days
Rebleeding in both groups
Measured: 6 weeks
Decompensation in both groups in the form of ascites or Hepatic Encephalopathy
Measured: 6 weeks
Adverse events in both groups
Measured: 6 weeks
Worsening of liver severity score in both groups.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2019
- Study start6 Feb 2019
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03827681
- Sponsor's protocol ID
- ILBS-Cirrhosis-20
- Status last verified
- Mar 2020
- First submitted
- 31 Jan 2019
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Singh S, Arora V, Maiwall R, Mukund A, Jindal A, Choudhry A, Kumar G, Sarin SK. TIPS Is Superior to SEMS in the Management of Refractory VARICEAL Bleed in Advanced Cirrhosis Patients (TIPSEMS-VB Trial). Liver Int. 2025 Aug;45(8):e70178. doi: 10.1111/liv.70178.
PubMed 40631454
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Study the Efficacy and Safety of TIPS (Trans Intrahepatic Portosystemic Shunt) Versus Self Expanding Metallic Stent (SEMS) in the Management of Refractory Variceal Bleed in Cirrhotics.
- ClinicalTrials.gov ID
- NCT03827681
- Acronym / sponsor ID
- ILBS-Cirrhosis-20
- 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
- 6 Feb 2019 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 1 Feb 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.
A total of 50 patients will be enrolled and will be randomized into either Group A(TIPS) or Group B (SEMS).
Primary end point of the study will be to compare efficacy of TIPS versus SEMS for survival at 6 week or Early re Bleed. All enrolled patients will also undergo HVPG measurement at baseline to stratify risk of failure to control bleed or early re-bleed.
Patient will be monitored for 5 days for re bleed, complications of therapy, worsening of Liver function tests and scores and efficacy of either treatment modality over other. Patient will be followed for 6 weeks to see for the primary end point.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TIPS + Vasoactive Drug | Experimental | Procedure: Trans Intrahepatic Portosystemic Shunt, Drug: Vasoactive Agent |
| SEMS + Vasoactive Drug | Active comparator | Procedure: Self Expanding Metallic Stent, Drug: Vasoactive Agent |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consecutive patients of cirrhosis aged 18-70 years presenting with acute variceal Bleeding, who on endoscopy fail to control bleed or rebleeds within 5 days will be randomized.
Key exclusion criteria (13 listed)
- Bleeding from non-variceal source
- Coagulopathy related bleed
- Bleeding from Gastric varices
- Any malignancy including HCC
- Main Portal vein thrombosis
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 |
|---|---|---|
| Trans Intrahepatic Portosystemic Shunt* The most common approach is through the right internal jugular approach. * After infiltrating the puncture site with 2% lignocaine and puncturing the vein a guide wire is advanced into the IVC followed by a 9F/10F vascular sheath. * A wedged venogram is performed with a peripherally placed hepatic vein catheter, which may identify a portion of the portal vein to facilitate subsequent puncture.' * A stiff guide wire is then passed through the catheter and the vascular sheath is advanced into the right hepatic vein. With the vascular sheath in place a rigid needle with 15-20 degrees of distal angulation is advanced over the guide wire and through the vascular sheath to enter the hepatic vein. | Procedure or surgery | TIPS + Vasoactive Drug |
| Self Expanding Metallic Stent* At upper endoscopy, a 0.35 Superstiff radiological guidewire with a soft tip (supplied with the stent insertion kit) is delivered into the stomach under direct vision and the endoscope is removed. * The stent delivery device is then advanced over the guidewire into the stomach, and the distal portion of the stent delivery system is withdrawn to allow inflation of the gastric balloon. * The gastric balloon is then inflated with 100 mL of air, and the whole delivery system is withdrawn until resistance is felt, which signifies that the balloon is impacting at the cardia, thus anchoring the distal end of the stent during deployment. * After stent deployment, the gastric balloon is deflated and the stent delivery system is withdrawn. The stent is then examined endoscopically. When deployed, the stent is 135 mm long and 25 mm wide. | Procedure or surgery | SEMS + Vasoactive Drug |
| Vasoactive AgentVasoactive Agent | Drug | SEMS + Vasoactive Drug, TIPS + Vasoactive Drug |
Primary outcome
Survival in both groups
Time frame: 6 weeks
5 secondary outcomes
Re-bleeding in both groups for 5 days from end of therapy
Time frame: 5 days
Rebleeding in both groups
Time frame: 6 weeks
Decompensation in both groups in the form of ascites or Hepatic Encephalopathy
Time frame: 6 weeks
Adverse events in both groups
Time frame: 6 weeks
Worsening of liver severity score in both groups.
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Derived from this study: PubMed 40631454Singh S, Arora V, Maiwall R, Mukund A, Jindal A, Choudhry A, Kumar G, Sarin SK. TIPS Is Superior to SEMS in the Management of Refractory VARICEAL Bleed in Advanced Cirrhosis Patients (TIPSEMS-VB Trial). Liver Int. 2025 Aug;45(8):e70178. doi: 10.1111/liv.70178.
- 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 Trans Intrahepatic Portosystemic Shunt, Self Expanding Metallic Stent and Vasoactive Agent 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 1 inclusion and 13 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 10 Mar 2020. 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 Shushrut Singh, MD (01146300000, drsushrut20@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival in both groups (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03827681, which also lists 1 linked publication.
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 10 Mar 2020.