CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 14 enrolled
Drug / intervention
Self-expanding mesh-metal oesophageal stent (SEMS) +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01851564
NCT01851564N/ACompleted
CompareCT.gov

Effective Haemostasis Using Self-expandable Covered Mesh-metal Oesophageal Stents Versus Standard Endoscopic Therapy in the Treatment of Oesophageal Variceal Haemorrhage: A Multicentre, Open, Prospective, Randomised, Controlled Study.

University College, London·interventional·Posted May 10, 2013·Updated Sep 20, 2016

In Brief

A clinical study evaluating Self-expanding mesh-metal oesophageal stent (SEMS) and Standard Therapy for Acute Bleeding Esophageal Varices. Completed, enrolled 14 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Bleeding Esophageal Varices
CountriesUnited Kingdom
CollaboratorsRoyal Free Hampstead NHS Trust, Barts & The London NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust

Timeline

N/ACompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 10, 2013
Enrollment StartAug 1, 2012
Primary CompletionAug 1, 2015
Study CompletionFeb 1, 2016
TodayJul 2, 2026
Enrollment to primary: 3 yearsPosted 13.1 years ago

Interventions

Self-expanding mesh-metal oesophageal stent (SEMS)device

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

Standard Therapyother

Standard Medical and Endoscopic Therapy