Effective haemostasis using self-expandable covered mesh-metal oesophageal stents versus standard endoscopic therapy in the emergency treatment of oesophageal variceal haemorrhage: A multicentre, open, prospective, randomised, controlled study

niversity College London (UK)0 个研究点目标入组 136 人开始时间: 2013年5月3日最近更新: 2019年5月13日

适应症

试验速览

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•Participants with Child-Pugh grade B or C cirrhosis with variceal haemorrhage, where the bleeding is from a site which would ordinarily be treated with band ligation (usually either oesophageal or GOV-1 varices). The diagnosis of cirrhosis may be proven by previous histology or suspected using clinical, radiological and biochemical data.
•Arm 2: Participants with Child-Pugh grade A, B or C cirrhosis who present with failure to control bleeding within 5 days of an initial attempt at standard endoscopic therapy of acute haemorrhage from a site which would ordinarily be treated with band ligation (usually either oesophageal or GOV-1 varices).
•Failure to control bleeding is demonstrated by the Baveno V criteria, either:
•1. Fresh Haematemesis (or >100mls of fresh blood aspirated via NG >2 hours after therapeutic endoscopy)
•2. Development of Hypovolaemic Shock
•3. 3g drop in Haemoglobin within any 24 hours period if no transfusion is administered
•Target Gender: Male & Female ; Lower Age Limit 18 years

•1. < 18 Years of age
•2. Child-Pugh grade A cirrhosis (Arm 1 only)
•3. Non-cirrhotic portal hypertension
•4. Malignancy of the oesophagus, stomach or upper respiratory tract
•5. Oesophageal stenosis which prohibits endoscopy
•6. Recent oesophageal surgery
•7. A large hiatus hernia which prevents stent placement
•8. Known hepatocellular carcinoma considered to be incurable (according to Milan Criteria).
•9. Patients in the terminal phases of hepatological or other disease.
•10. Pregnancy

发起方

niversity College London (UK)