RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage (SOV)

September 19, 2016 updated by: University College, London

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.

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 such that survival rates of patients with Childs-Pugh A and B class cirrhosis may be as high as 90% at 30 days. However, the successful outcome of variceal bleeding is compromised in some patients because of initial failure to control bleeding or early re-bleeding, both of which have a significant impact on mortality.

The SX-Ella Danis stent (Ella-CS, Hradec Kralove, Czech Republic) is a removable, covered, self-expanding mesh-metal stent (SEMS) that can be deployed in the lower oesophagus over an endoscopically placed guidewire without radiological screening. The stent controls bleeding by tamponade of varices in the lower oesophagus.

The series reported to date suggest that the self-expandable covered stents can provide 100% haemostasis rates when applied for refractory oesophageal variceal bleeding. Given the potentially lower risks of re-bleeding and safe, easy insertion techniques the self-expandable covered stents may offer a superior alternative to standard endoscopic therapy.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Bristol, United Kingdom, BS2 8HW
        • United Bristol Hospitals NHS Foundation Trust
      • London, United Kingdom, NW3 2QG
        • Royal Free London NHS Foundation Trust
      • London, United Kingdom, E1 1BB
        • Barts Health NHS Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SEMS for primary variceal haemorrhage
Use of the Self-expanding mesh-metal oesophageal stent (SEMS) as primary therapy for Acute Variceal Haemorrhage.
Device: Self-expanding mesh-metal oesophageal stent (SEMS)
A removable stent designed for the treatment of bleeding oesophageal varices.
Other Names:
  • DANIS Stent
Active Comparator: Standard Therapy - Primary Haemorrhage
Use of standard medical and endoscopic therapy for the treatment of primary variceal haemorrhage.
Other: Standard Therapy
Standard Medical and Endoscopic Therapy
Experimental: SEMS for Failure to Control Bleeding
Use of the self expanding mesh-metal stent for failure of standard therapy in oesophageal variceal haemorrhage.
Device: Self-expanding mesh-metal oesophageal stent (SEMS)
A removable stent designed for the treatment of bleeding oesophageal varices.
Other Names:
  • DANIS Stent
Active Comparator: Standard Therapy - Failure of Control
Use of standard medical and endoscopic therapy for failure of standard therapy in oesophageal variceal haemorrhage.
Other: Standard Therapy
Standard Medical and Endoscopic Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure to Control Bleeding
Time Frame: 7 days
Failure to control Bleeding (as defined by the Baveno V Criteria) or re-bleeding within 7 days.
7 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absence of Bleeding at 14 and 42 days
Time Frame: 14 and 42 days
14 and 42 days
Participant Survival
Time Frame: 7, 14, 42 days and 6 months
7, 14, 42 days and 6 months
Absence of Stent Migration
Time Frame: 7 days
for the duration of stent migration
7 days
Requirement for Blood products
Time Frame: 7 days
7 days
Requirement for Analgesia and Sedation whilst Stent in in situ
Time Frame: 7 days
7 days
Presence of Thoracic Pain or Dysphagia
Time Frame: 7 days
7 days
Length of Intensive Care Unit and Total Hospital Stay
Time Frame: Total Length of Intensive Care Unit and Hospital Stay (an average of 3 and 10 days respectively)
Total Length of Intensive Care Unit and Hospital Stay (an average of 3 and 10 days respectively)
Requirement for additional endoscopic therapy or salvage therapy (such as TIPS)
Time Frame: 7 days
7 days
Repeated presentation with variceal bleeding within 6 months
Time Frame: 6 months
6 months

Other Outcome Measures

Outcome Measure
Time Frame
Unexpected Serious Adverse Device Effect
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

Barts & The London NHS Trust
University Hospitals Bristol and Weston NHS Foundation Trust
Royal Free Hampstead NHS Trust

Investigators

  • Principal Investigator: James O'Beirne, MBBS FRCP, Royal Free London NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

August 1, 2015

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

December 21, 2012

First Submitted That Met QC Criteria

May 7, 2013

First Posted (Estimate)

May 10, 2013

Study Record Updates

Last Update Posted (Estimate)

September 20, 2016

Last Update Submitted That Met QC Criteria

September 19, 2016

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 74570
  • 11/0261 (Other Identifier: Sponsors Reference (UCL))
  • 13392 (Registry Identifier: UK Clinical Research Network Portfolio Database)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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