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Confocal Laser Endomicroscopy and Endoscopic Mucosal Resection

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01124994
First Posted: May 18, 2010
Last Update Posted: January 23, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Werner Dolak, MD, Medical University of Vienna
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Endomicroscopy-targeted Endoscopic Mucosa Resection for Barrett's Oesophagus-associated Neoplasia

Resource links provided by NLM:


Further study details as provided by Werner Dolak, MD, Medical University of Vienna:

Primary Outcome Measures:
  • Accuracy of CLE-EMR [ Time Frame: 2 years ]
    Accuracy of CLE to detect the exact borders of high grade intraepithelial neoplasia within Barrett's epithelium, confirmed by histological evaluation of resected specimens.


Enrollment: 38
Study Start Date: July 2011
Study Completion Date: December 2013
Primary Completion Date: July 2013 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01124994


Locations
Austria
Medical University of Vienna
Vienna, Austria
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:
Kiesslich R, Galle P, Neurath M. Atlas of endomicroscopy. Springer Medical Publishing. 2008

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
First Submitted: May 17, 2010
First Posted: May 18, 2010
Last Update Posted: January 23, 2014
Last Verified: January 2014

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

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