Fully, Coated, Removable, Self-expanding Oesophageal Stents for the Prevention of Oesophageal Stricture Following Endoscopic Mucosal Resection of Short Segment Barrett's With High Grade Dysplasia and Early Cancer.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Constriction, Pathological
- Sponsor
- Professor Michael Bourke
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Improvement in Stricture Formation
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Professor Michael Bourke
Dr Michael Bourke
Western Sydney Local Health District
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Improvement in Stricture Formation
Time Frame: 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.