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
United Bristol Healthcare NHS 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
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by University College, London:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Unexpected Serious Adverse Device Effect [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 136
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01851564

Contacts
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

Locations
United Kingdom
United Bristol Hospitals NHS Foundation Trust Recruiting
Bristol, United Kingdom, BS2 8HW
Contact: Anne McCune         
Principal Investigator: Anne McCune         
Royal Free London NHS Foundation Trust Recruiting
London, United Kingdom, NW3 2QG
Principal Investigator: James O'Beirne         
Sub-Investigator: Brian Hogan         
Sub-Investigator: David Patch         
Sub-Investigator: Andrew Burroughs         
Barts Health NHS Trust Recruiting
London, United Kingdom, E1 1BB
Contact: Patrick Kennedy         
Principal Investigator: Patrick Kennedy         
Sponsors and Collaborators
University College, London
Royal Free Hampstead NHS Trust
Barts & The London NHS Trust
United Bristol Healthcare NHS 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, 13392
Study First Received: December 21, 2012
Last Updated: May 7, 2013
Health Authority: United Kingdom: National Institute for Health Research
United Kingdom: Research Ethics Committee

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

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

ClinicalTrials.gov processed this record on August 27, 2014