RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage

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.

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