Stent Oesophageal Varices: Effective haemostasis using self-expandable covered mesh-metal oesophageal stents versus standard endoscopic therapy in the emergency treatment of oesophageal variceal haemorrhage

Not Applicable

Completed

• Conditions: Topic: Blood, Oral and Gastrointestinal; Subtopic: Blood (all Subtopics), Oral and Gastrointestinal (all Subtopics); Disease: Non-malignant haematology, Hepatology; Digestive System; Oesophageal varices with bleeding

• Registration Number: ISRCTN98310189
• Lead Sponsor: niversity College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-05-03
• Study Completion: 2014-08-31
• Last Update Posted: 13 May 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 136

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 (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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Failure to control bleeding (as defined by the Baveno V criteria) or re-bleeding within 7 days.

Secondary Outcome Measures

Name	Time	Method
ot provided at time of registration