RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage

NCT01851564 | Completed DMC

• 3 other identifiers: 7457011/026113392
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 3

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.

Conditions

Acute Bleeding Esophageal Varices

Keywords

Gastrointestinal Haemorrhage; Varices; Liver Cirrhosis; Stent

Outcome Measures

Primary Outcomes (1)

• Failure to Control Bleeding

  Failure to control Bleeding (as defined by the Baveno V Criteria) or re-bleeding within 7 days.

  7 days

Secondary Outcomes (9)

• Absence of Bleeding at 14 and 42 days

  14 and 42 days

• Participant Survival

  7, 14, 42 days and 6 months

• Absence of Stent Migration

  7 days

• Requirement for Blood products

  7 days

• Requirement for Analgesia and Sedation whilst Stent in in situ

  7 days

Other Outcomes (1)

• Unexpected Serious Adverse Device Effect

  6 months

Study Arms (4)

SEMS for primary variceal haemorrhage

EXPERIMENTAL

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)

Standard Therapy - Primary Haemorrhage

ACTIVE COMPARATOR

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

Other: Standard Therapy

SEMS for Failure to Control Bleeding

EXPERIMENTAL

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)

Standard Therapy - Failure of Control

ACTIVE COMPARATOR

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

Other: Standard Therapy

Interventions

Self-expanding mesh-metal oesophageal stent (SEMS) DEVICE

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

Also known as: DANIS Stent

SEMS for Failure to Control Bleeding; SEMS for primary variceal haemorrhage

Standard Therapy OTHER

Standard Medical and Endoscopic Therapy

Standard Therapy - Failure of Control; Standard Therapy - Primary Haemorrhage

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \< 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

Sponsors & Collaborators

• University College, London: lead
• Royal Free Hampstead NHS Trust: collaborator
• Barts & The London NHS Trust: collaborator
• University Hospitals Bristol and Weston NHS Foundation Trust: collaborator

Study Sites (3)

United Bristol Hospitals NHS Foundation Trust

Bristol, BS2 8HW, United Kingdom

Location

Barts Health NHS Trust

London, E1 1BB, United Kingdom

Location

Royal Free London NHS Foundation Trust

London, NW3 2QG, United Kingdom

Location

Related Publications (10)

• 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.

  PMID: 15349904 BACKGROUND

• 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.

  PMID: 19092789 BACKGROUND

• 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.

  PMID: 10488702 BACKGROUND

• 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.

  PMID: 12939586 BACKGROUND

• 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.

  PMID: 20638742 BACKGROUND

• 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.

  PMID: 16981106 BACKGROUND

• 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.

  PMID: 18622540 BACKGROUND

• 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.

  PMID: 19879564 BACKGROUND

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

  PMID: 2679046 BACKGROUND

• 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.

  PMID: 17879356 BACKGROUND

MeSH Terms

Conditions

Gastrointestinal Hemorrhage; Varicose Veins; Liver Cirrhosis

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases; Cardiovascular Diseases; Liver Diseases; Fibrosis

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• James O'Beirne, MBBS FRCP

  Royal Free London NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 21, 2012
• First Posted: May 10, 2013
• Study Start: August 1, 2012
• Primary Completion: August 1, 2015
• Study Completion: February 1, 2016
• Last Updated: September 20, 2016

Record last verified: 2015-06

Locations

GB (3)