Status:
COMPLETED
RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage
Lead Sponsor:
University College, London
Collaborating Sponsors:
Royal Free Hampstead NHS Trust
Barts & The London NHS Trust
Conditions:
Acute Bleeding Esophageal Varices
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 havin...
Detailed Description
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 s...
Eligibility Criteria
Inclusion
- 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
- \< 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
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2016
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT01851564
Start Date
August 1 2012
End Date
February 1 2016
Last Update
September 20 2016
Active Locations (3)
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1
United Bristol Hospitals NHS Foundation Trust
Bristol, United Kingdom, BS2 8HW
2
Barts Health NHS Trust
London, United Kingdom, E1 1BB
3
Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG