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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Professor Michael Bourke, Western Sydney Local Health District
ClinicalTrials.gov Identifier:
NCT01554280
First received: March 11, 2012
Last updated: June 30, 2014
Last verified: June 2014
  Purpose

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 Intervention
Constriction, Pathological
Device: Fully coated, removable , self-expanding oesophageal stent

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Western Sydney Local Health District:

Primary Outcome Measures:
  • Improvement in Stricture Formation [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 12
Study Start Date: January 2012
Study Completion Date: January 2014
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01554280

Locations
Australia, New South Wales
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Sponsors and Collaborators
Professor Michael Bourke
Investigators
Principal Investigator: Michael Bourke, MBBS Sydney WAHS
  More Information

No publications provided

Responsible Party: Professor Michael Bourke, Dr Michael Bourke, Western Sydney Local Health District
ClinicalTrials.gov Identifier: NCT01554280     History of Changes
Other Study ID Numbers: CBE-001-SEOS
Study First Received: March 11, 2012
Last Updated: June 30, 2014
Health Authority: Australia: Human Research Ethics Committee

Keywords provided by Western Sydney Local Health District:
Stricture
Dysphagia

Additional relevant MeSH terms:
Constriction, Pathologic
Esophageal Stenosis
Pathological Conditions, Anatomical
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on July 24, 2014