RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage

Acute Bleeding Esophageal Varices Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01851564
• Other study ID #: 74570
• Secondary ID: 11/026113392
• Status: Completed
• Phase: N/A
• First received: December 21, 2012
• Last updated: September 19, 2016
• Start date: August 2012
• Est. completion date: February 2016

Study information

• Verified date: June 2015
• Source: University College, London
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Institute for Health ResearchUnited Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: February 2016
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Bleeding Esophageal Varices
• Esophageal and Gastric Varices
• Gastrointestinal Hemorrhage
• Hemorrhage

Intervention

Device:
• Self-expanding mesh-metal oesophageal stent (SEMS)
A removable stent designed for the treatment of bleeding oesophageal varices.

Other:
• Standard Therapy
Standard Medical and Endoscopic Therapy

Locations

Country	Name	City	State
United Kingdom	United Bristol Hospitals NHS Foundation Trust	Bristol
United Kingdom	Barts Health NHS Trust	London
United Kingdom	Royal Free London NHS Foundation Trust	London

Sponsors (4)

Lead Sponsor	Collaborator
University College, London	Barts & The London NHS Trust, Royal Free Hampstead NHS Trust, University Hospitals Bristol NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

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. Erratum in: J Hepatol 2001 Apr;34(4):640. — View 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. — View Citation

Carbonell N, Pauwels A, Serfaty L, Fourdan O, Lévy VG, Poupon R. Improved survival after variceal bleeding in patients with cirrhosis over the past two decades. Hepatology. 2004 Sep;40(3):652-9. — View 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. — View 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. — View 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. Erratum in: Hepatology. 2007 Dec;46(6):2052. — View Citation

Hubmann R, Bodlaj G, Czompo M, Benkö L, Pichler P, Al-Kathib S, Kiblböck 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Unexpected Serious Adverse Device Effect		6 months	Yes
Primary	Failure to Control Bleeding	Failure to control Bleeding (as defined by the Baveno V Criteria) or re-bleeding within 7 days.	7 days	No
Secondary	Absence of Bleeding at 14 and 42 days		14 and 42 days	No
Secondary	Participant Survival		7, 14, 42 days and 6 months	No
Secondary	Absence of Stent Migration	for the duration of stent migration	7 days	No
Secondary	Requirement for Blood products		7 days	No
Secondary	Requirement for Analgesia and Sedation whilst Stent in in situ		7 days	No
Secondary	Presence of Thoracic Pain or Dysphagia		7 days	No
Secondary	Length of Intensive Care Unit and Total Hospital Stay		Total Length of Intensive Care Unit and Hospital Stay (an average of 3 and 10 days respectively)	No
Secondary	Requirement for additional endoscopic therapy or salvage therapy (such as TIPS)		7 days	No
Secondary	Repeated presentation with variceal bleeding within 6 months		6 months	No