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NCT03827681
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.
NA trial testing Trans Intrahepatic Portosystemic Shunt in Liver Cirrhoses in 50 participants. Status unknown.
30 June 2020
Quick facts
| Lead sponsor | Institute of Liver and Biliary Sciences, India |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 50 |
| Start date | 6 February 2019 |
| Primary completion | 30 June 2020 |
| Estimated completion | 30 June 2020 |
| Sites | 1 location across India |
Drugs / interventions tested
- Trans Intrahepatic Portosystemic Shunt
- Self Expanding Metallic Stent
- Vasoactive Agent — full drug profile →
Conditions studied
- Liver Cirrhoses — all drugs for Liver Cirrhoses →
Sponsor
Institute of Liver and Biliary Sciences, India
Who can join
Adults 18 to 70, any sex, with Liver Cirrhoses. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
TIPS Is Superior to SEMS in the Management of Refractory VARICEAL Bleed in Advanced Cirrhosis Patients (TIPSEMS-VB Trial).
Singh S, Arora V, Maiwall R, Mukund A, et al · · 2025 · cited 3× · PMID 40631454 · DOI 10.1111/liv.70178
Verify or expand the search:
- PubMed search for NCT03827681
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Institute of Liver and Biliary Sciences, India trials
Trials by the same sponsor.
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- NCT07433881 — Serosurvey of HAV Immunity and Single-dose Vaccine Immunogenicity Among Patients With Cirrhosis · not yet recruiting
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03827681 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Institute of Liver and Biliary Sciences, India
- Last refreshed: 10 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03827681.
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