RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage

Study Overview
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Brief Summary
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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
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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.

Official Title
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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.

Conditions
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Acute Bleeding Esophageal Varices

Intervention / Treatment
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* Device: Self-expanding mesh-metal oesophageal stent (SEMS)
* Other: Standard Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SEMS for primary variceal haemorrhage<br>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)<br>* A removable stent designed for the treatment of bleeding oesophageal varices.<br>* Other names: DANIS Stent;|
| Active Comparator: Standard Therapy - Primary Haemorrhage<br>Use of standard medical and endoscopic therapy for the treatment of primary variceal haemorrhage. | Other: Standard Therapy<br>* Standard Medical and Endoscopic Therapy<br>|
| Experimental: SEMS for Failure to Control Bleeding<br>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)<br>* A removable stent designed for the treatment of bleeding oesophageal varices.<br>* Other names: DANIS Stent;|
| Active Comparator: Standard Therapy - Failure of Control<br>Use of standard medical and endoscopic therapy for failure of standard therapy in oesophageal variceal haemorrhage. | Other: Standard Therapy<br>* Standard Medical and Endoscopic Therapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Failure to Control Bleeding | Failure to control Bleeding (as defined by the Baveno V Criteria) or re-bleeding within 7 days. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | for the duration of stent migration | 7 days | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Gastrointestinal Haemorrhage, Varices, Liver Cirrhosis, Stent