Back to resultsFully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision. (CBE-001-SEOS)
Primary Purpose
Constriction, Pathological
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Fully coated, removable , self-expanding oesophageal stent
Sponsored by
About this trial
This is an interventional prevention trial for Constriction, Pathological focused on measuring Stricture, Dysphagia
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.
Sites / Locations
- Westmead Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Oesophageal Stents
Arm Description
Patients enrolled will receive a fully coated, removable, self-expanding oesophageal stent.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01554280
First Posted
March 11, 2012
Last Updated
March 22, 2021
Sponsor
Professor Michael Bourke
1. Study Identification
Unique Protocol Identification Number
NCT01554280
Brief Title
Fully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision.
Acronym
CBE-001-SEOS
Official Title
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
January 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Professor Michael Bourke
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Constriction, Pathological
Keywords
Stricture, Dysphagia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Oesophageal Stents
Arm Type
Experimental
Arm Description
Patients enrolled will receive a fully coated, removable, self-expanding oesophageal stent.
Intervention Type
Device
Intervention Name(s)
Fully coated, removable , self-expanding oesophageal stent
Intervention Description
Insertion of the fully coated, removable, self-expanding oesophageal stent for the prevention of oesophageal strictures.
Primary Outcome Measure Information:
Title
Improvement in Stricture Formation
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Bourke, MBBS
Organizational Affiliation
WSLHD
Official's Role
Principal Investigator
Facility Information:
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
12. IPD Sharing Statement
Citations:
PubMed Identifier
25442084
Citation
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.
Results Reference
derived
Learn more about this trial
Fully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision.
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