Acute Bleeding Esophageal Varices Clinical Trial
Official title:
Effective Haemostasis Using Self-expandable Covered Mesh-metal Oesophageal Stents Versus Standard Endoscopic Therapy in the Treatment of Oesophageal Variceal Haemorrhage: A Multicentre, Open, Prospective, Randomised, Controlled Study.
The mortality rates from Acute Variceal Haemorrhage remain significant and first line therapy may fail in 15-25% of patients. The self-expandable metal stent has been described in case series as having a very high efficacy at control of haemorrhage from oesophageal varices when used as rescue therapy. This randomised controlled trial aims to assess for any potential superiority of the stent over 'standard' endoscopic techniques as primary or rescue therapy for bleeding oesophageal varices.
Despite improvements in recent years, mortality from variceal bleeding remains significant.
The routine use of banding ligation, vasoactive drugs, and antibiotics has had an impact on
survival rates such that survival rates of patients with Childs-Pugh A and B class cirrhosis
may be as high as 90% at 30 days. However, the successful outcome of variceal bleeding is
compromised in some patients because of initial failure to control bleeding or early
re-bleeding, both of which have a significant impact on mortality.
The SX-Ella Danis stent (Ella-CS, Hradec Kralove, Czech Republic) is a removable, covered,
self-expanding mesh-metal stent (SEMS) that can be deployed in the lower oesophagus over an
endoscopically placed guidewire without radiological screening. The stent controls bleeding
by tamponade of varices in the lower oesophagus.
The series reported to date suggest that the self-expandable covered stents can provide 100%
haemostasis rates when applied for refractory oesophageal variceal bleeding. Given the
potentially lower risks of re-bleeding and safe, easy insertion techniques the
self-expandable covered stents may offer a superior alternative to standard endoscopic
therapy.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase 3 | |
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N/A |