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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by University College, London
Sponsor:
Collaborators:
Royal Free Hampstead NHS Trust
Barts & The London NHS Trust
University Hospitals Bristol NHS Foundation Trust
Information provided by (Responsible Party):
University College, London
ClinicalTrials.gov Identifier:
NCT01851564
First received: December 21, 2012
Last updated: May 7, 2013
Last verified: April 2013

December 21, 2012
May 7, 2013
August 2012
February 2014   (final data collection date for primary outcome measure)
Failure to Control Bleeding [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Failure to control Bleeding (as defined by the Baveno V Criteria) or re-bleeding within 7 days.
Same as current
Complete list of historical versions of study NCT01851564 on ClinicalTrials.gov Archive Site
  • Absence of Bleeding at 14 and 42 days [ Time Frame: 14 and 42 days ] [ Designated as safety issue: No ]
  • Participant Survival [ Time Frame: 7, 14, 42 days and 6 months ] [ Designated as safety issue: No ]
  • Absence of Stent Migration [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    for the duration of stent migration
  • Requirement for Blood products [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Requirement for Analgesia and Sedation whilst Stent in in situ [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Presence of Thoracic Pain or Dysphagia [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • Requirement for additional endoscopic therapy or salvage therapy (such as TIPS) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Repeated presentation with variceal bleeding within 6 months [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Same as current
Unexpected Serious Adverse Device Effect [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
 
RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Acute Bleeding Esophageal Varices
  • Device: Self-expanding mesh-metal oesophageal stent (SEMS)
    A removable stent designed for the treatment of bleeding oesophageal varices.
    Other Name: DANIS Stent
  • Other: Standard Therapy
    Standard Medical and Endoscopic Therapy
  • Experimental: SEMS for primary variceal haemorrhage
    Use of the Self-expanding mesh-metal oesophageal stent (SEMS) as primary therapy for Acute Variceal Haemorrhage.
    Intervention: Device: Self-expanding mesh-metal oesophageal stent (SEMS)
  • Active Comparator: Standard Therapy - Primary Haemorrhage
    Use of standard medical and endoscopic therapy for the treatment of primary variceal haemorrhage.
    Intervention: Other: Standard 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.
    Intervention: Device: Self-expanding mesh-metal oesophageal stent (SEMS)
  • Active Comparator: Standard Therapy - Failure of Control
    Use of standard medical and endoscopic therapy for failure of standard therapy in oesophageal variceal haemorrhage.
    Intervention: Other: Standard Therapy

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
136
August 2014
February 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Brian Hogan +44 (0) 20 7794 0500 ext 31494 brianhogan@nhs.net
Contact: James O'Beirne +44 (0) 20 7794 0500 ext 38097 jobeirne@nhs.net
United Kingdom
 
NCT01851564
74570, 11/0261, 13392
Yes
University College, London
University College, London
  • Royal Free Hampstead NHS Trust
  • Barts & The London NHS Trust
  • University Hospitals Bristol NHS Foundation Trust
Principal Investigator: James O'Beirne, MBBS FRCP Royal Free London NHS Foundation Trust
University College, London
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP