Acute Bleeding Esophageal Varices | RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage
Acute Bleeding Esophageal Varices research study
What is the primary objective of this 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.
Who is eligible to participate?
Inclusion Criteria: - Arm 1: 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 . 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. Exclusion Criteria: - < 18 Years of age - Child-Pugh grade A cirrhosis (for Arm 1 only) - Varices which would not be treated with band ligation as standard therapy - Non-cirrhotic portal hypertension - Malignancy of the oesophagus, stomach or upper respiratory tract - Oesophageal stenosis which prohibits endoscopy - Recent oesophageal surgery - A large hiatus hernia which prevents stent placement - Known hepatocellular carcinoma considered to be incurable (according to Milan Criteria) - Patients in the terminal phases of hepatological or other disease - Pregnancy
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Acute Bleeding Esophageal Varices
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Device:Self-expanding mesh-metal oesophageal stent (SEMS)A removable stent designed for the treatment of bleeding oesophageal varices.
Other:Standard TherapyStandard Medical and Endoscopic Therapy
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
SEMS for primary variceal haemorrhageUse of the Self-expanding mesh-metal oesophageal stent (SEMS) as primary therapy for Acute Variceal Haemorrhage.
Standard Therapy - Primary HaemorrhageUse of standard medical and endoscopic therapy for the treatment of primary variceal haemorrhage.
SEMS for Failure to Control BleedingUse of the self expanding mesh-metal stent for failure of standard therapy in oesophageal variceal haemorrhage.
Standard Therapy - Failure of ControlUse of standard medical and endoscopic therapy for failure of standard therapy in oesophageal variceal haemorrhage.
Start Date: August 2012
Completed Date: February 2016
Primary Outcome: Failure to Control Bleeding
Secondary Outcome: Absence of Bleeding at 14 and 42 days
Study sponsors, principal investigator, and references
Principal Investigator: James O'Beirne, MBBS FRCP
Lead Sponsor: University College, London
Collaborator: Royal Free Hampstead NHS Trust
Carbonell N, Pauwels A, Serfaty L, Fourdan O, Lévy VG, Poupon R. Improved survival after variceal bleeding in patients with cirrhosis over the past two decades. Hepatology. 2004 Sep;40(3):652-9.