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

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.

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Key information

Conditions

Constriction, Pathological Constriction, Pathologic Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pharyngeal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Westmead Hospital

Westmead, New South Wales, 2145, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fully coated, removable , self-expanding oesophageal stent

Device

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

Primary outcomes

Improvement in Stricture Formation

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Professor Michael Bourke

Other

Registry information

Official study 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.

Acronym: CBE-001-SEOS

Important dates

Study start: 2012
Primary completion: 2013
Study completion: 2014
First posted: Mar 14, 2012
Registry last updated: Mar 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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