Fully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision. (CBE-001-SEOS)

Professor Michael Bourke

Status: Completed

Conditions: Constriction, Pathological

Treatments: Device: Fully coated, removable , self-expanding oesophageal stent

Study type: Interventional

Funder types: Other

Identifiers

NCT01554280

CBE-001-SEOS

Details and patient eligibility

About

The purpose of this study is to investigate whether preventative placement of a removable oesophageal stent reduces the rate of scar tissue, or stricture formation after removing the precancerous or early cancerous Barrett's mucosa by Endoscopic Mucosal Resection (EMR). The stent will be placed 10-14 days after initial EMR. The stent will then be removed 8 weeks later by repeat Endoscopy. Patients will be followed up weekly following insertion of the oesophageal stent.

Enrollment: 12 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with short segment Barrett's Oesophagus with high grade dysplasia or early cancer, having circumferential EMR to achieve complete Barrett's excision.
• Aged 18-75 years old
• Biopsy proven to be Barretts with HGD or EAC
• The absence or lymph node involvement
• Short segment <3cm of Barretts Oesophagus.

Exclusion criteria

• Women who are pregnant and the human foetus
• Children and/or young people <18 years
• People with an intellectual or mental impairment.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Oesophageal Stents

Experimental group

Description:

Patients enrolled will receive a fully coated, removable, self-expanding oesophageal stent.

Treatment:

Device: Fully coated, removable , self-expanding oesophageal stent