Fully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision.

Not Applicable

Completed

• Conditions: Constriction, Pathological
• Interventions: Device: Fully coated, removable , self-expanding oesophageal stent

• Registration Number: NCT01554280
• Lead Sponsor: Professor Michael Bourke

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-03-11
• Study First Submitted QC: 2012-03-13
• Study First Posted: 2012-03-14
• Primary Completion: 2013-01
• Study Completion: 2014-01
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-22
• Last Update Posted: 2021-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Oesophageal Stents	Fully coated, removable , self-expanding oesophageal stent	Patients enrolled will receive a fully coated, removable, self-expanding oesophageal stent.

Primary Outcome Measures

Name	Time	Method
Improvement in Stricture Formation	12 weeks	Initial evaluation of Dysphagia score which is used to assess the stricture formation prior to EMR. Followed by weekly phone calls to assess ability to swallow liquids and food.

Trial Locations

Locations (1)

Westmead Hospital; 🇦🇺 Westmead, New South Wales, Australia