CompletedNot Applicable

pCLE in the Detection of Esophageal and Gastric Lesions and Intestinal Metaplasia or Dysplasia in Patients After Endoscopic Treatment of BORN

Czechia67 participantsStarted 2016-04

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

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

Trial details

NCT IDNCT02922049

SponsorInstitute for Clinical and Experimental Medicine

Sponsor typeOTHER_GOV

Study typeINTERVENTIONAL

Primary completion2019-04

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