CBE-001-SEOS: Fully Coated, Removable, Self-expanding Oesophageal Stents for Preventing Strictures Following Complete Barretts Excision.

Sponsor

Professor Michael Bourke (Other)

Overall Status

Completed

CT.gov ID

NCT01554280

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Constriction, Pathological	Device: Fully coated, removable , self-expanding oesophageal stent	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

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 Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Jan 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Oesophageal Stents Patients enrolled will receive a fully coated, removable, self-expanding oesophageal stent.	Device: Fully coated, removable , self-expanding oesophageal stent Insertion of the fully coated, removable, self-expanding oesophageal stent for the prevention of oesophageal strictures.

Arm

Intervention/Treatment

Experimental: Oesophageal Stents

Patients enrolled will receive a fully coated, removable, self-expanding oesophageal stent.

Device: Fully coated, removable , self-expanding oesophageal stent

Insertion of the fully coated, removable, self-expanding oesophageal stent for the prevention of oesophageal strictures.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Westmead Hospital	Westmead	New South Wales	Australia	2145

Sponsors and Collaborators

Professor Michael Bourke

Investigators

Principal Investigator: Michael Bourke, MBBS, WSLHD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Professor Michael Bourke, Dr Michael Bourke, Western Sydney Local Health District

ClinicalTrials.gov Identifier:

NCT01554280

Other Study ID Numbers:

CBE-001-SEOS

First Posted:

Mar 14, 2012

Last Update Posted:

Mar 23, 2021

Last Verified:

Mar 1, 2021

Keywords provided by Professor Michael Bourke, Dr Michael Bourke, Western Sydney Local Health District

Stricture

Dysphagia

Additional relevant MeSH terms:

Constriction, Pathologic

Study Results

No Results Posted as of Mar 23, 2021