Clinical Trial: RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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, Prospect

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 Summary:

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.


Sponsor: University College, London

Current Primary Outcome: Failure to Control Bleeding [ Time Frame: 7 days ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Absence of Bleeding at 14 and 42 days [ Time Frame: 14 and 42 days ]
  • Participant Survival [ Time Frame: 7, 14, 42 days and 6 months ]
  • Absence of Stent Migration [ Time Frame: 7 days ]
    for the duration of stent migration
  • Requirement for Blood products [ Time Frame: 7 days ]
  • Requirement for Analgesia and Sedation whilst Stent in in situ [ Time Frame: 7 days ]
  • Presence of Thoracic Pain or Dysphagia [ Time Frame: 7 days ]
  • 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) ]
  • Requirement for additional endoscopic therapy or salvage therapy (such as TIPS) [ Time Frame: 7 days ]
  • Repeated presentation with variceal bleeding within 6 months [ Time Frame: 6 months ]


Original Secondary Outcome: Same as current

Information By: University College, London

Dates:
Date Received: December 21, 2012
Date Started: August 2012
Date Completion:
Last Updated: September 19, 2016
Last Verified: June 2015