RCT of Stent Versus Standard Therapy in Oesophageal Variceal Haemorrhage (SOV)

University College London (UCL)

Status: Completed

Conditions: Acute Bleeding Esophageal Varices

Treatments: Device: Self-expanding mesh-metal oesophageal stent (SEMS); Other: Standard Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01851564

74570

13392 (Registry Identifier)

11/0261 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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14 participants in 4 patient groups

SEMS for primary variceal haemorrhage

Experimental group

Description:

Use of the Self-expanding mesh-metal oesophageal stent (SEMS) as primary therapy for Acute Variceal Haemorrhage.

Treatment:

Device: Self-expanding mesh-metal oesophageal stent (SEMS)

Standard Therapy - Primary Haemorrhage

Active Comparator group

Description:

Use of standard medical and endoscopic therapy for the treatment of primary variceal haemorrhage.

Treatment:

Other: Standard Therapy

SEMS for Failure to Control Bleeding

Experimental group

Description:

Use of the self expanding mesh-metal stent for failure of standard therapy in oesophageal variceal haemorrhage.

Treatment:

Device: Self-expanding mesh-metal oesophageal stent (SEMS)

Standard Therapy - Failure of Control

Active Comparator group

Description:

Use of standard medical and endoscopic therapy for failure of standard therapy in oesophageal variceal haemorrhage.

Treatment:

Other: Standard Therapy