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.
N/A
18 Years
75 Years
18 Years
75 Years
Open (Enrolling)
Both
Constriction, Pathological
Both
Constriction, Pathological
Trial Information
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.
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.
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Outcome Measure:
Improvement in Stricture Formation
Outcome Description:
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.
Outcome Time Frame:
12 weeks
Safety Issue:
No
Principal Investigator
Michael Bourke, MBBS
Investigator Role:
Principal Investigator
Investigator Affiliation:
Sydney WAHS
Authority:
Australia: Human Research Ethics Committee
Study ID:
CBE-001-SEOS
NCT ID:
NCT01554280
Start Date:
January 2012
Completion Date:
January 2014
Related Keywords:
- Constriction, Pathological
- Stricture
- Dysphagia
- Constriction, Pathologic
- Esophageal Diseases
- Esophageal Stenosis
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