Clinical trial NCT01851564: RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Bleeding Esophageal Varices
Keywords: Gastrointestinal Haemorrhage
Varices
Liver Cirrhosis
Stent
Lead sponsor: University College, London
Sponsor class: OTHER
Collaborators: name: Royal Free Hampstead NHS Trust
name: Barts & The London NHS Trust
name: University Hospitals Bristol and Weston NHS Foundation Trust
First posted: 2013-05-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Failure to Control Bleeding
timeFrame: 7 days
Secondary outcomes:
measure: Absence of Bleeding at 14 and 42 days
timeFrame: 14 and 42 days
measure: Participant Survival
timeFrame: 7, 14, 42 days and 6 months
measure: Absence of Stent Migration
timeFrame: 7 days
measure: Requirement for Blood products
timeFrame: 7 days
measure: Requirement for Analgesia and Sedation whilst Stent in in situ
timeFrame: 7 days
measure: Presence of Thoracic Pain or Dysphagia
timeFrame: 7 days
measure: Length of Intensive Care Unit and Total Hospital Stay
timeFrame: Total Length of Intensive Care Unit and Hospital Stay (an average of 3 and 10 days respectively)
measure: Requirement for additional endoscopic therapy or salvage therapy (such as TIPS)
timeFrame: 7 days
measure: Repeated presentation with variceal bleeding within 6 months
timeFrame: 6 months
Other outcomes:
measure: Unexpected Serious Adverse Device Effect
timeFrame: 6 months
Locations:
city: Bristol
country: United Kingdom
facility: United Bristol Hospitals NHS Foundation Trust
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Royal Free London NHS Foundation Trust
Study officials:
affiliation: Royal Free London NHS Foundation Trust
name: James O'Beirne, MBBS FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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