Acute Bleeding Esophageal Varices
Conditions
Keywords
Gastrointestinal Haemorrhage, Varices, Liver Cirrhosis, Stent
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.
Interventions
DEVICESelf-expanding mesh-metal oesophageal stent (SEMS)
A removable stent designed for the treatment of bleeding oesophageal varices.
OTHERStandard Therapy
Standard Medical and Endoscopic Therapy
Sponsors
Royal Free Hampstead NHS Trust
Barts & The London NHS Trust
University Hospitals Bristol and Weston NHS Foundation Trust
University College, London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Failure to Control Bleeding | 7 days | Failure to control Bleeding (as defined by the Baveno V Criteria) or re-bleeding within 7 days. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| 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 | — |
| Requirement for Analgesia and Sedation whilst Stent in in situ | 7 days | — |
Other
| Measure | Time frame |
|---|---|
| Unexpected Serious Adverse Device Effect | 6 months |
Countries
United Kingdom
Outcome results
None listed