Clinical trial · Interventional
Confocal Laser Endomicroscopy and Endoscopic Mucosal Resection
Endomicroscopy-targeted Endoscopic Mucosa Resection for Barrett's Oesophagus-associated Neoplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Barrett's Mucosa With High Grade Intraepithelial Neoplasia (HGIEN) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Endoscopic mucosal resection | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- ACTIVE_COMPARATOR
- label
- Mucosectomy
- description
- Patients in this arm are undergoing mucosctomy after previous confocal laser endomicroscopy.
- interventionNames
- Procedure: Endoscopic mucosal resection
Primary outcomes (1)
- measure
- Accuracy of CLE-EMR
- timeFrame
- 2 years
- description
- Accuracy of CLE to detect the exact borders of high grade intraepithelial neoplasia within Barrett's epithelium, confirmed by histological evaluation of resected specimens.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (10)
- BACKGROUNDHolscher 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 19131920
- BACKGROUNDShaheen NJ, Richter JE. Barrett's oesophagus. Lancet. 2009 Mar 7;373(9666):850-61. doi: 10.1016/S0140-6736(09)60487-6. PMID 19269522
- BACKGROUNDSpechler 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 15784042
- BACKGROUNDCurvers 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 19065483
- BACKGROUNDKara 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 16189764
- BACKGROUNDKiesslich R, Galle P, Neurath M. Atlas of endomicroscopy. Springer Medical Publishing. 2008
- BACKGROUNDKiesslich 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 16843068
- BACKGROUNDDunbar 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.