Fully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision.
CBE-001-SEOS
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.
1 other identifier
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2012
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 11, 2012
CompletedFirst Posted
Study publicly available on registry
March 14, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2014
CompletedMarch 23, 2021
March 1, 2021
1 year
March 11, 2012
March 22, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Improvement in Stricture Formation
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.
12 weeks
Study Arms (1)
Oesophageal Stents
EXPERIMENTALPatients enrolled will receive a fully coated, removable, self-expanding oesophageal stent.
Interventions
Insertion of the fully coated, removable, self-expanding oesophageal stent for the prevention of oesophageal strictures.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Women who are pregnant and the human foetus
- Children and/or young people \<18 years
- People with an intellectual or mental impairment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Related Publications (1)
Holt BA, Jayasekeran V, Williams SJ, Lee EY, Bahin FF, Sonson R, Lord RV, Bourke MJ. Early metal stent insertion fails to prevent stricturing after single-stage complete Barrett's excision for high-grade dysplasia and early cancer. Gastrointest Endosc. 2015 Apr;81(4):857-64. doi: 10.1016/j.gie.2014.08.022. Epub 2014 Oct 16.
PMID: 25442084DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael Bourke, MBBS
WSLHD
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Dr Michael Bourke
Study Record Dates
First Submitted
March 11, 2012
First Posted
March 14, 2012
Study Start
January 1, 2012
Primary Completion
January 1, 2013
Study Completion
January 1, 2014
Last Updated
March 23, 2021
Record last verified: 2021-03