RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage

NCT ID: NCT01851564

Last Updated: 2016-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2016-02-29

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.

Conditions

Acute Bleeding Esophageal Varices

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

SEMS for primary variceal haemorrhage

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

Group Type: EXPERIMENTAL

Self-expanding mesh-metal oesophageal stent (SEMS)

Intervention Type: DEVICE

A removable stent designed for the treatment of bleeding oesophageal varices.

Standard Therapy - Primary Haemorrhage

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

Group Type: ACTIVE_COMPARATOR

Standard Therapy

Intervention Type: OTHER

Standard Medical and Endoscopic Therapy

SEMS for Failure to Control Bleeding

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

Group Type: EXPERIMENTAL

Self-expanding mesh-metal oesophageal stent (SEMS)

Intervention Type: DEVICE

A removable stent designed for the treatment of bleeding oesophageal varices.

Standard Therapy - Failure of Control

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

Group Type: ACTIVE_COMPARATOR

Standard Therapy

Intervention Type: OTHER

Standard Medical and Endoscopic Therapy

Interventions

Self-expanding mesh-metal oesophageal stent (SEMS)

A removable stent designed for the treatment of bleeding oesophageal varices.

Intervention Type: DEVICE

Standard Therapy

Standard Medical and Endoscopic Therapy

Intervention Type: OTHER

Other Intervention Names

DANIS Stent

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Royal Free Hampstead NHS Trust

OTHER

Sponsor Role: collaborator

Barts & The London NHS Trust

OTHER

Sponsor Role: collaborator

University Hospitals Bristol and Weston NHS Foundation Trust

OTHER

Sponsor Role: collaborator

University College, London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

James O'Beirne, MBBS FRCP

Role: PRINCIPAL_INVESTIGATOR

Royal Free London NHS Foundation Trust

Locations

United Bristol Hospitals NHS Foundation Trust

Bristol, , United Kingdom

Barts Health NHS Trust

London, , United Kingdom

Royal Free London NHS Foundation Trust

London, , United Kingdom

Countries

United Kingdom

References

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Reference Type: BACKGROUND

PMID: 10488702 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12939586 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 20638742 (View on PubMed)

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

PMID: 18622540 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19879564 (View on PubMed)

Sarin SK, Kumar A. Gastric varices: profile, classification, and management. Am J Gastroenterol. 1989 Oct;84(10):1244-9.

Reference Type: BACKGROUND

PMID: 2679046 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17879356 (View on PubMed)

Other Identifiers

11/0261

Identifier Type: OTHER

Identifier Source: secondary_id

13392

Identifier Type: REGISTRY

Identifier Source: secondary_id

74570

Identifier Type: -

Identifier Source: org_study_id