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

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ClinicalTrials.gov Identifier: NCT01851564
Recruitment Status : Completed
First Posted : May 10, 2013
Last Update Posted : September 20, 2016
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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 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.

Condition or disease Intervention/treatment
Acute Bleeding Esophageal Varices Device: Self-expanding mesh-metal oesophageal stent (SEMS) Other: Standard Therapy

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 14 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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.
Study Start Date : August 2012
Primary Completion Date : August 2015
Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: 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 Name: 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


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Absence of Bleeding at 14 and 42 days [ Time Frame: 14 and 42 days ]
  2. Participant Survival [ Time Frame: 7, 14, 42 days and 6 months ]
  3. Absence of Stent Migration [ Time Frame: 7 days ]
    for the duration of stent migration

  4. Requirement for Blood products [ Time Frame: 7 days ]
  5. Requirement for Analgesia and Sedation whilst Stent in in situ [ Time Frame: 7 days ]
  6. Presence of Thoracic Pain or Dysphagia [ Time Frame: 7 days ]
  7. 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) ]
  8. Requirement for additional endoscopic therapy or salvage therapy (such as TIPS) [ Time Frame: 7 days ]
  9. Repeated presentation with variceal bleeding within 6 months [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Unexpected Serious Adverse Device Effect [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01851564


Locations
United Kingdom
United Bristol Hospitals NHS Foundation Trust
Bristol, United Kingdom, BS2 8HW
Barts Health NHS Trust
London, United Kingdom, E1 1BB
Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
University College, London
Royal Free Hampstead NHS Trust
Barts & The London NHS Trust
University Hospitals Bristol NHS Foundation Trust
Investigators
Principal Investigator: James O'Beirne, MBBS FRCP Royal Free London NHS Foundation Trust
More Information

Publications:

Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01851564     History of Changes
Other Study ID Numbers: 74570
11/0261 ( Other Identifier: Sponsors Reference (UCL) )
13392 ( Registry Identifier: UK Clinical Research Network Portfolio Database )
First Posted: May 10, 2013    Key Record Dates
Last Update Posted: September 20, 2016
Last Verified: June 2015

Keywords provided by University College, London:
Gastrointestinal Haemorrhage
Varices
Liver Cirrhosis
Stent

Additional relevant MeSH terms:
Hemorrhage
Esophageal and Gastric Varices
Gastrointestinal Hemorrhage
Pathologic Processes
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Hypertension, Portal
Liver Diseases