Clinical trial · Interventional
pCLE in the Detection of Esophageal and Gastric Lesions and Intestinal Metaplasia or Dysplasia in Patients After Endoscopic Treatment of BORN
Probe-based Confocal Laser Endomicroscopy in Accurate Histopathologic Diagnosis of Neoplastic Gastrointestinal Lesion
NCT02922049CI-TRIAL-00043474completedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
To assess diagnostic accuracy and clinical effectiveness including cost-effectiveness analysis of pCLE in patients after finishing the endoscopic treatment of BORN in detecting persistent/recurrent IM, recurrent neoplasia and buried glands.
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 Esophagus | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Biopsies with histopathology | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- pCLE vs. biopsies with histopathology
- description
- The investigators will compare diagnostic accuracy and sensitivity of pCLE with standard biopsies in patients with esophageal and gastric lesions and in patients after completed endoscopic treatment of BORN. All samples taken by biopsies will be correlated with the images taken by pCLE in the detection of lesions, intestinal metaplasia, dysplasia and buried glands.
- interventionNames
- Other: Biopsies with histopathology
Primary outcomes (1)
- measure
- Detection of persistent or recurrent intestinal metaplasia/dysplasia and esophageal and gastric lesions by confocal laser endomicroscopy and classic histopathology
- timeFrame
- till 3 day after procedure
Secondary outcomes (1)
- measure
- Sensitivity and specificity of the procedure
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age \> 18 * macroscopic lesion of esophagus or stomach (Project A) * pts after ER/ESD/RFA for BORN (Project B) * eradication of BORN and Barrett's esophagus macro- and microscopically (Project B) * sign agreement with study Exclusion Criteria: * macroscopic persistence of Barrett's esophagus (e.g. tongues) * esophageal varices * treatment with anticoagulants * allergy to fluorescein * polyvalent allergy * pregnancy
References
Publications (12)
- BACKGROUNDSharma P, Meining AR, Coron E, Lightdale CJ, Wolfsen HC, Bansal A, Bajbouj M, Galmiche JP, Abrams JA, Rastogi A, Gupta N, Michalek JE, Lauwers GY, Wallace MB. Real-time increased detection of neoplastic tissue in Barrett's esophagus with probe-based confocal laser endomicroscopy: final results of an international multicenter, prospective, randomized, controlled trial. Gastrointest Endosc. 2011 Sep;74(3):465-72. doi: 10.1016/j.gie.2011.04.004. Epub 2011 Jul 13. PMID 21741642
- BACKGROUNDMeining A, Shah RJ, Slivka A, Pleskow D, Chuttani R, Stevens PD, Becker V, Chen YK. Classification of probe-based confocal laser endomicroscopy findings in pancreaticobiliary strictures. Endoscopy. 2012 Mar;44(3):251-7. doi: 10.1055/s-0031-1291545. Epub 2012 Jan 19. PMID 22261749
- BACKGROUNDShahid MW, Buchner AM, Coron E, Woodward TA, Raimondo M, Dekker E, Fockens P, Wallace MB. Diagnostic accuracy of probe-based confocal laser endomicroscopy in detecting residual colorectal neoplasia after EMR: a prospective study. Gastrointest Endosc. 2012 Mar;75(3):525-33. doi: 10.1016/j.gie.2011.08.024. Epub 2011 Nov 1. PMID 22051243
- BACKGROUNDMusquer N, Coquenlorge S, Bourreille A, Aubert P, Matysiak-Budnik T, des Varannes SB, Lauwers G, Neunlist M, Coron E. Probe-based confocal laser endomicroscopy: a new method for quantitative analysis of pit structure in healthy and Crohn's disease patients. Dig Liver Dis. 2013 Jun;45(6):487-92. doi: 10.1016/j.dld.2013.01.018. Epub 2013 Mar 7. PMID 23466186
- BACKGROUNDMannath J, Subramanian V, Kaye PV, Ragunath K. Life-threatening bleeding following Barrett's surveillance biopsies. Endoscopy. 2010;42 Suppl 2:E211-2. doi: 10.1055/s-0030-1255717. Epub 2010 Sep 15. No abstract available. PMID 20845277
- BACKGROUNDKopacova M, Bures J, Osterreicher J, Kvetina J, Pejchal J, Tacheci I, Kunes M, Spelda S, Rejchrt S. Confocal laser endomicroscopy in experimental pigs. Methods of ex vivo imaging. Cas Lek Cesk. 2009;148(6):249-53.