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

Primary Purpose

Acute Bleeding Esophageal Varices

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Self-expanding mesh-metal oesophageal stent (SEMS)
Standard Therapy
Sponsored by
University College, London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Bleeding Esophageal Varices focused on measuring Gastrointestinal Haemorrhage, Varices, Liver Cirrhosis, Stent

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • United Bristol Hospitals NHS Foundation Trust
  • Barts Health NHS Trust
  • Royal Free London NHS Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

SEMS for primary variceal haemorrhage

Standard Therapy - Primary Haemorrhage

SEMS for Failure to Control Bleeding

Standard Therapy - Failure of Control

Arm Description

Use of the Self-expanding mesh-metal oesophageal stent (SEMS) as primary therapy for Acute Variceal Haemorrhage.

Use of standard medical and endoscopic therapy for the treatment of primary variceal haemorrhage.

Use of the self expanding mesh-metal stent for failure of standard therapy in oesophageal variceal haemorrhage.

Use of standard medical and endoscopic therapy for failure of standard therapy in oesophageal variceal haemorrhage.

Outcomes

Primary Outcome Measures

Failure to Control Bleeding
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
Participant Survival
Absence of Stent Migration
for the duration of stent migration
Requirement for Blood products
Requirement for Analgesia and Sedation whilst Stent in in situ
Presence of Thoracic Pain or Dysphagia
Length of Intensive Care Unit and Total Hospital Stay
Requirement for additional endoscopic therapy or salvage therapy (such as TIPS)
Repeated presentation with variceal bleeding within 6 months

Full Information

First Posted
December 21, 2012
Last Updated
September 19, 2016
Sponsor
University College, London
Collaborators
Royal Free Hampstead NHS Trust, Barts & The London NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust
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1. Study Identification

Unique Protocol Identification Number
NCT01851564
Brief Title
RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage
Acronym
SOV
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 Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
August 2015 (Actual)
Study Completion Date
February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University College, London
Collaborators
Royal Free Hampstead NHS Trust, Barts & The London NHS Trust, University Hospitals Bristol and Weston NHS Foundation Trust

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Bleeding Esophageal Varices
Keywords
Gastrointestinal Haemorrhage, Varices, Liver Cirrhosis, Stent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SEMS for primary variceal haemorrhage
Arm Type
Experimental
Arm Description
Use of the Self-expanding mesh-metal oesophageal stent (SEMS) as primary therapy for Acute Variceal Haemorrhage.
Arm Title
Standard Therapy - Primary Haemorrhage
Arm Type
Active Comparator
Arm Description
Use of standard medical and endoscopic therapy for the treatment of primary variceal haemorrhage.
Arm Title
SEMS for Failure to Control Bleeding
Arm Type
Experimental
Arm Description
Use of the self expanding mesh-metal stent for failure of standard therapy in oesophageal variceal haemorrhage.
Arm Title
Standard Therapy - Failure of Control
Arm Type
Active Comparator
Arm Description
Use of standard medical and endoscopic therapy for failure of standard therapy in oesophageal variceal haemorrhage.
Intervention Type
Device
Intervention Name(s)
Self-expanding mesh-metal oesophageal stent (SEMS)
Other Intervention Name(s)
DANIS Stent
Intervention Description
A removable stent designed for the treatment of bleeding oesophageal varices.
Intervention Type
Other
Intervention Name(s)
Standard Therapy
Intervention Description
Standard Medical and Endoscopic Therapy
Primary Outcome Measure Information:
Title
Failure to Control Bleeding
Description
Failure to control Bleeding (as defined by the Baveno V Criteria) or re-bleeding within 7 days.
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Absence of Bleeding at 14 and 42 days
Time Frame
14 and 42 days
Title
Participant Survival
Time Frame
7, 14, 42 days and 6 months
Title
Absence of Stent Migration
Description
for the duration of stent migration
Time Frame
7 days
Title
Requirement for Blood products
Time Frame
7 days
Title
Requirement for Analgesia and Sedation whilst Stent in in situ
Time Frame
7 days
Title
Presence of Thoracic Pain or Dysphagia
Time Frame
7 days
Title
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)
Title
Requirement for additional endoscopic therapy or salvage therapy (such as TIPS)
Time Frame
7 days
Title
Repeated presentation with variceal bleeding within 6 months
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Unexpected Serious Adverse Device Effect
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James O'Beirne, MBBS FRCP
Organizational Affiliation
Royal Free London NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
United Bristol Hospitals NHS Foundation Trust
City
Bristol
ZIP/Postal Code
BS2 8HW
Country
United Kingdom
Facility Name
Barts Health NHS Trust
City
London
ZIP/Postal Code
E1 1BB
Country
United Kingdom
Facility Name
Royal Free London NHS Foundation Trust
City
London
ZIP/Postal Code
NW3 2QG
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
15349904
Citation
Carbonell N, Pauwels A, Serfaty L, Fourdan O, Levy VG, Poupon R. Improved survival after variceal bleeding in patients with cirrhosis over the past two decades. Hepatology. 2004 Sep;40(3):652-9. doi: 10.1002/hep.20339.
Results Reference
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PubMed Identifier
19092789
Citation
Burroughs AK, Triantos CK, O'Beirne J, Patch D. Predictors of early rebleeding and mortality after acute variceal hemorrhage in patients with cirrhosis. Nat Clin Pract Gastroenterol Hepatol. 2009 Feb;6(2):72-3. doi: 10.1038/ncpgasthep1336. Epub 2008 Dec 17.
Results Reference
background
PubMed Identifier
10488702
Citation
Ben-Ari Z, Cardin F, McCormick AP, Wannamethee G, Burroughs AK. A predictive model for failure to control bleeding during acute variceal haemorrhage. J Hepatol. 1999 Sep;31(3):443-50. doi: 10.1016/s0168-8278(99)80035-x. Erratum In: J Hepatol 2001 Apr;34(4):640.
Results Reference
background
PubMed Identifier
12939586
Citation
D'Amico G, De Franchis R; Cooperative Study Group. Upper digestive bleeding in cirrhosis. Post-therapeutic outcome and prognostic indicators. Hepatology. 2003 Sep;38(3):599-612. doi: 10.1053/jhep.2003.50385.
Results Reference
background
PubMed Identifier
20638742
Citation
de Franchis R; Baveno V Faculty. Revising consensus in portal hypertension: report of the Baveno V consensus workshop on methodology of diagnosis and therapy in portal hypertension. J Hepatol. 2010 Oct;53(4):762-8. doi: 10.1016/j.jhep.2010.06.004. Epub 2010 Jun 27. No abstract available.
Results Reference
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PubMed Identifier
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Citation
Hubmann R, Bodlaj G, Czompo M, Benko L, Pichler P, Al-Kathib S, Kiblbock P, Shamyieh A, Biesenbach G. The use of self-expanding metal stents to treat acute esophageal variceal bleeding. Endoscopy. 2006 Sep;38(9):896-901. doi: 10.1055/s-2006-944662.
Results Reference
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PubMed Identifier
18622540
Citation
Zehetner J, Shamiyeh A, Wayand W, Hubmann R. Results of a new method to stop acute bleeding from esophageal varices: implantation of a self-expanding stent. Surg Endosc. 2008 Oct;22(10):2149-52. doi: 10.1007/s00464-008-0009-7. Epub 2008 Jul 12.
Results Reference
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PubMed Identifier
19879564
Citation
Wright G, Lewis H, Hogan B, Burroughs A, Patch D, O'Beirne J. A self-expanding metal stent for complicated variceal hemorrhage: experience at a single center. Gastrointest Endosc. 2010 Jan;71(1):71-8. doi: 10.1016/j.gie.2009.07.028. Epub 2009 Oct 30.
Results Reference
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PubMed Identifier
2679046
Citation
Sarin SK, Kumar A. Gastric varices: profile, classification, and management. Am J Gastroenterol. 1989 Oct;84(10):1244-9.
Results Reference
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PubMed Identifier
17879356
Citation
Garcia-Tsao G, Sanyal AJ, Grace ND, Carey W; Practice Guidelines Committee of the American Association for the Study of Liver Diseases; Practice Parameters Committee of the American College of Gastroenterology. Prevention and management of gastroesophageal varices and variceal hemorrhage in cirrhosis. Hepatology. 2007 Sep;46(3):922-38. doi: 10.1002/hep.21907. No abstract available. Erratum In: Hepatology. 2007 Dec;46(6):2052.
Results Reference
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RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage

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