RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage

Not Applicable

Completed

• Conditions: Acute Bleeding Esophageal Varices

• Registration Number: NCT01851564
• Lead Sponsor: University College, London

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-12-21
• Study First Submitted QC: 2013-05-07
• Study First Posted: 2013-05-10
• Status Verified: 2015-06
• Primary Completion: 2015-08
• Study Completion: 2016-02
• Last Update Submitted: 2016-09-19
• Last Update Posted: 2016-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	for the duration of stent migration
Requirement for Blood products	7 days
Requirement for Analgesia and Sedation whilst Stent in in situ	7 days
Presence of Thoracic Pain or Dysphagia	7 days
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)
Requirement for additional endoscopic therapy or salvage therapy (such as TIPS)	7 days
Repeated presentation with variceal bleeding within 6 months	6 months

Trial Locations

Locations (3)

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