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NCT04207398
TIPS vs. NSBB Plus Endotherapy for the Prevention of Variceal Rebleeding in NSBB Non-responders of Primary Prophylaxis
NA trial testing Transjugular intrahepatic portosystemic shunts in Variceal Hemorrhage in 114 participants. Status unknown.
31 December 2022
Quick facts
| Lead sponsor | Air Force Military Medical University, China |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 114 |
| Start date | 1 June 2020 |
| Primary completion | 31 December 2022 |
| Estimated completion | 31 December 2022 |
Drugs / interventions tested
- Transjugular intrahepatic portosystemic shunts
- Nonselective β-blocker (NSBB)+ endoscopic band ligation (EBL)
Conditions studied
- Variceal Hemorrhage — all drugs for Variceal Hemorrhage →
- TIPS — all drugs for TIPS →
- NSBB — all drugs for NSBB →
- Liver Cirrhosis — all drugs for Liver Cirrhosis →
Sponsor
Air Force Military Medical University, China
Who can join
Adults 18 to 75, any sex, with Variceal Hemorrhage or TIPS. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Variceal bleeding (VB) is a life-threatening complication of cirrhosis with a 6-week mortality of approximately 15%-20%. The 1-year rate of recurrent VB is approximately 60% in patients without prophylaxis treatment. Therefore, all patients who survive VB must receive active treatments to prevent rebleeding. Usually, these patients are submitted to rebleeding prophylaxis with endoscopic band ligation (EBL) combined with non-selective beta-blockers (NSBB). Transjugular intrahepatic portosystemic shunts (TIPS) are reserved for those who failed endoscopic plus medical treatment. A recent meta-analysis comparing combination therapy to monotherapy with EBL or drug therapy has demonstrated that combination therapy is only marginally more effective than NSBB alone. This suggests that NSBB is the cornerstone of combination therapy. The lowest rebleeding rates are observed in patients on secondary prophylaxis who are hepatic venous pressure gradient (HVPG) responders (defined as a reduction in HVPG below 12 mm Hg or \> 20% from baseline). A recent study demonstrated that patients who have their first episode of variceal bleeding while on primary prophylaxis with NSBB have an increased risk of further bleeding and death, despite adding EBL. These patients possibly require alternative treatment approaches, such as TIPS. The aim of the present study was to compare the effect of TIPS vs. EBL + NSBB for the prevention of rebleeding in NSBB non-responder for primary prophylaxis.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04207398
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Related trials
Other recruiting trials for Variceal Hemorrhage
Currently open trials in the same condition.
- NCT06437964 — Prophylactic Antibiotics in Endoscopic Secondary Prevention of Gastroesophageal Variceal Bleeding · NA · active not recruiting
- NCT03267615 — VICIS - Vienna Cirrhosis Study · recruiting
Other Air Force Military Medical University, China trials
Trials by the same sponsor.
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- NCT07365345 — Frequency of Electrical Acupoint Stimulation on Hypotension in TAVR Patients · NA · 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 NCT04207398 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Air Force Military Medical University, China
- Last refreshed: 5 February 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/NCT04207398.
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