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

Constriction, Pathological Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01554280
• Other study ID #: CBE-001-SEOS
• Status: Completed
• Phase: N/A
• Start date: January 2012
• Est. completion date: January 2014

Study information

• Verified date: March 2021
• Source: Western Sydney Local Health District
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 2014
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Constriction, Pathological

Intervention

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

Locations

Country	Name	City	State
Australia	Westmead Hospital	Westmead	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Professor Michael Bourke

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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