NCT01124994

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 17, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 18, 2010

Completed
1.1 years until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

2 years

First QC Date

May 17, 2010

Last Update Submit

January 22, 2014

Conditions

Barrett's Mucosa With High Grade Intraepithelial Neoplasia (HGIEN)

Keywords

Barrett's oesophagusHigh grade intraepithelial neoplasia (HGIEN)

Outcome Measures

Primary Outcomes (1)

  • Accuracy of CLE-EMR

    Accuracy of CLE to detect the exact borders of high grade intraepithelial neoplasia within Barrett's epithelium, confirmed by histological evaluation of resected specimens.

    2 years

Study Arms (1)

Mucosectomy

ACTIVE COMPARATOR

Patients in this arm are undergoing mucosctomy after previous confocal laser endomicroscopy.

Procedure: Endoscopic mucosal resection

Interventions

Endoscopic mucosal resectionPROCEDURE

Confocal laser endomicroscopy will be used to target endoscopic mucosal resection of Barrett's oesophagus-associated neoplasia

Mucosectomy

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna

Vienna, Austria

Location

Related Publications (10)

  • Holscher AH, Vallbohmer D, Bollschweiler E. Early Barrett's carcinoma of the esophagus. Ann Thorac Cardiovasc Surg. 2008 Dec;14(6):347-54. No abstract available.

    PMID: 19131920BACKGROUND

  • Shaheen NJ, Richter JE. Barrett's oesophagus. Lancet. 2009 Mar 7;373(9666):850-61. doi: 10.1016/S0140-6736(09)60487-6.

    PMID: 19269522BACKGROUND

  • Spechler SJ. Dysplasia in Barrett's esophagus: limitations of current management strategies. Am J Gastroenterol. 2005 Apr;100(4):927-35. doi: 10.1111/j.1572-0241.2005.41201.x.

    PMID: 15784042BACKGROUND

  • Curvers WL, Bansal A, Sharma P, Bergman JJ. Endoscopic work-up of early Barrett's neoplasia. Endoscopy. 2008 Dec;40(12):1000-7. doi: 10.1055/s-0028-1103409. Epub 2008 Dec 8. No abstract available.

    PMID: 19065483BACKGROUND

  • Kara MA, Peters FP, Rosmolen WD, Krishnadath KK, ten Kate FJ, Fockens P, Bergman JJ. High-resolution endoscopy plus chromoendoscopy or narrow-band imaging in Barrett's esophagus: a prospective randomized crossover study. Endoscopy. 2005 Oct;37(10):929-36. doi: 10.1055/s-2005-870433.

    PMID: 16189764BACKGROUND

  • Kiesslich R, Galle P, Neurath M. Atlas of endomicroscopy. Springer Medical Publishing. 2008

    BACKGROUND

  • Kiesslich R, Gossner L, Goetz M, Dahlmann A, Vieth M, Stolte M, Hoffman A, Jung M, Nafe B, Galle PR, Neurath MF. In vivo histology of Barrett's esophagus and associated neoplasia by confocal laser endomicroscopy. Clin Gastroenterol Hepatol. 2006 Aug;4(8):979-87. doi: 10.1016/j.cgh.2006.05.010. Epub 2006 Jul 13.

    PMID: 16843068BACKGROUND

  • Dunbar KB, Okolo P 3rd, Montgomery E, Canto MI. Confocal laser endomicroscopy in Barrett's esophagus and endoscopically inapparent Barrett's neoplasia: a prospective, randomized, double-blind, controlled, crossover trial. Gastrointest Endosc. 2009 Oct;70(4):645-54. doi: 10.1016/j.gie.2009.02.009. Epub 2009 Jun 25.

    PMID: 19559419BACKGROUND

  • Leung KK, Maru D, Abraham S, Hofstetter WL, Mehran R, Anandasabapathy S. Optical EMR: confocal endomicroscopy-targeted EMR of focal high-grade dysplasia in Barrett's esophagus. Gastrointest Endosc. 2009 Jan;69(1):170-2. doi: 10.1016/j.gie.2008.03.1068. Epub 2008 Jun 25. No abstract available.

    PMID: 18582880BACKGROUND

  • Ahmadi A, Draganov P. Endoscopic mucosal resection in the upper gastrointestinal tract. World J Gastroenterol. 2008 Apr 7;14(13):1984-9. doi: 10.3748/wjg.14.1984.

    PMID: 18395896BACKGROUND

MeSH Terms

Conditions

Barrett Esophagus

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Study Officials

  • Andreas Puespoek, MD

    Medical University of Vienna

    STUDY DIRECTOR

  • Werner Dolak, MD

    Medical University of Vienna, Department of Internal Medicine III, Division of Gastroenterology and Hepatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prinicpal Investigator

Study Record Dates

First Submitted

May 17, 2010

First Posted

May 18, 2010

Study Start

July 1, 2011

Primary Completion

July 1, 2013

Study Completion

December 1, 2013

Last Updated

January 23, 2014

Record last verified: 2014-01

Locations

AU(1)