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Confocal Laser Endomicroscopy and Endoscopic Mucosal Resection

This study is currently recruiting participants.
Verified October 2012 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Werner Dolak, MD, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01124994
First received: May 17, 2010
Last updated: October 6, 2012
Last verified: October 2012
History of Changes
  Purpose

The accurate detection and therapy of adenocarcinoma originating from Barrett's oesophagus is challenging as current endoscopic techniques are unreliable for both the detection of high grade intraepithelial neoplasia (HGIN) within Barrett's mucosa and the correct measurement of the dimension of such neoplastic lesions. Confocal laser endomicroscopy (CLE) is a promising technology that could help to close this gap. Relying on first clinical trials of CLE, which showed remarkable results for the detection of Barrett's associated neoplasia, the investigators want to use CLE as targeting tool for endoscopic mucosal resection of HGIN in patients suffering from Barrett's oesophagus. CLE-mapping of neoplastic lesions will be documented and compared to the later performed histological evaluation of the resected specimen. If CLE is passing our challenge this will be another valuable proof of its high potential as reliable new endoscopic technology. Its usage could increase the en-bloc resection rate and decrease the amount of repetitive resections, which would remarkably improve the patients comfort.


Condition Intervention
Barrett's Mucosa With High Grade Intraepithelial Neoplasia (HGIEN)
 Procedure: Endoscopic mucosal resection

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Endomicroscopy-targeted Endoscopic Mucosa Resection for Barrett's Oesophagus-associated Neoplasia

Resource links provided by NLM:

MedlinePlus related topics: Cancer Endoscopy
U.S. FDA Resources

Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • Accuracy of CLE-EMR [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Accuracy of CLE to detect the exact borders of high grade intraepithelial neoplasia within Barrett's epithelium, confirmed by histological evaluation of resected specimens.


Estimated Enrollment: 40
Study Start Date: July 2010
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Mucosectomy
Patients in this arm are undergoing mucosctomy after previous confocal laser endomicroscopy.
 Procedure: Endoscopic mucosal resection
Confocal laser endomicroscopy will be used to target endoscopic mucosal resection of Barrett's oesophagus-associated neoplasia

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients referred to our department for endoscopic mucosal resection (EMR) of Barrett's mucosa with high grade intraepithelial neoplasia (HGIN) that has been detected during routine upper endoscopy or Barrett's surveillance endoscopy at our department or at another hospital.

Exclusion Criteria:

  • patients allergic to one of the drug components (including drugs used for conscious sedation like propofol or midazolam as well as fluorescein, the fluorescent dye used for CLE )
  • patients presenting with contraindications to EMR (low platelet count, therapeutic anticoagulation, coagulation disorders)
  • refusal to participate in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01124994

Contacts
Contact: Werner Dolak, MD 00431404006589 werner.dolak@meduniwien.ac.at
Contact: Andreas Puespoek, MD 00431404004739 andreas.puespoek@meduniwien.ac.at

Locations
Austria
Medical University of Vienna Recruiting
Vienna, Austria
Contact: Werner Dolak, MD     0043 1 40400 6589     werner.dolak@meduniwien.ac.at    
Contact: Andreas Puespoek, Prof.     0043 1 40400 4739     andreas.puespoek@meduniwien.ac.at    
Principal Investigator: Werner Dolak, MD            
Sponsors and Collaborators
Medical University of Vienna
Investigators
Study Director: Andreas Puespoek, MD Medical University of Vienna
Principal Investigator: Werner Dolak, MD Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology
  More Information

Publications:
Hölscher AH, Vallböhmer D, Bollschweiler E. Early Barrett's carcinoma of the esophagus. Ann Thorac Cardiovasc Surg. 2008 Dec;14(6):347-54.
Shaheen NJ, Richter JE. Barrett's oesophagus. Lancet. 2009 Mar 7;373(9666):850-61.

Responsible Party: Werner Dolak, MD, Prinicpal Investigator, Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01124994     History of Changes
Other Study ID Numbers: EK 697/2009
Study First Received: May 17, 2010
Last Updated: October 6, 2012
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Vienna:
Barrett's oesophagus
High grade intraepithelial neoplasia (HGIEN)

Additional relevant MeSH terms:
Barrett Esophagus
Neoplasms
Carcinoma in Situ
Digestive System Abnormalities
Digestive System Diseases
 Esophageal Diseases
Gastrointestinal Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type

ClinicalTrials.gov processed this record on May 16, 2013