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RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage

NCT01851564 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2016-09-20

No results posted yet for this study

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 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.

Conditions

  • Acute Bleeding Esophageal Varices

Interventions

DEVICE

Self-expanding mesh-metal oesophageal stent (SEMS)

A removable stent designed for the treatment of bleeding oesophageal varices.

OTHER

Standard Therapy

Standard Medical and Endoscopic Therapy

Sponsors & Collaborators

  • Royal Free Hampstead NHS Trust

    collaborator OTHER

  • Barts & The London NHS Trust

    collaborator OTHER

  • University Hospitals Bristol and Weston NHS Foundation Trust

    collaborator OTHER

  • University College, London

    lead OTHER

Principal Investigators

  • James O'Beirne, MBBS FRCP · Royal Free London NHS Foundation Trust

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2015-08-31
Completion
2016-02-29

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01851564 on ClinicalTrials.gov