The Accuracy of Optic Biopsies Versus Conventional Biopsies for the Diagnosis of Superficial Bladder Neoplasia
NCT ID: NCT02841904
Last Updated: 2018-03-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
189 participants
INTERVENTIONAL
2018-06-30
2019-12-31
Brief Summary
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Detailed Description
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This study evaluates the ability of CLE to assess tissue in the bladder. The ability to diagnose normal mucosa, inflammation and tumors of the bladder by the CLE is compared to the histopathological examination of selected tissues (biopsies).
Patients scheduled for cystoscopy with biopsies in general anesthesia are recruited for the study. After standard cystoscopy where suspicious mucosal areas are located and marked, A contrast agent (Fluorescein) is administrated intravenously. CLE fiber is introduced through the cystoscope and the marked mucosal areas are examined by direct contact with the laser fiber. The pathologist assesses the CLE video and registers the results. Biopsies are then taken from the selected, suspicious areas. The results of CLE assessment are compared with the histopathological results.
Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
SINGLE
Study Groups
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CLE
CLE assessed by the pathologist
Confocal LASER Endomicroscopy
Patients scheduled for bladder endoscopic surgery under general anesthesia are offered to be included in our study. The suspicious mucosal areas are marked then examined with CLE. Tissue samples are taken based on the usual standard criterias. The samples are evaluated microscopically and compared with the results of the CLE technique. A single surgeon performs all surgeries. Biopsies are anlysed by a pathologist from Herlev and Gentofte Hospital's Pathology Department, which is affiliated CLE- study.
Biopsy
Histology assessed by the pathologist
Confocal LASER Endomicroscopy
Patients scheduled for bladder endoscopic surgery under general anesthesia are offered to be included in our study. The suspicious mucosal areas are marked then examined with CLE. Tissue samples are taken based on the usual standard criterias. The samples are evaluated microscopically and compared with the results of the CLE technique. A single surgeon performs all surgeries. Biopsies are anlysed by a pathologist from Herlev and Gentofte Hospital's Pathology Department, which is affiliated CLE- study.
Interventions
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Confocal LASER Endomicroscopy
Patients scheduled for bladder endoscopic surgery under general anesthesia are offered to be included in our study. The suspicious mucosal areas are marked then examined with CLE. Tissue samples are taken based on the usual standard criterias. The samples are evaluated microscopically and compared with the results of the CLE technique. A single surgeon performs all surgeries. Biopsies are anlysed by a pathologist from Herlev and Gentofte Hospital's Pathology Department, which is affiliated CLE- study.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Suspicious mucosa / Carcinoma in situ
* Recurrent pTa
* Positive cytology with normal flexible cystoscopy
* Control after Bacille Calmette Guérin (BCG) treatment
Exclusion Criteria
* Pregnant and lactating women.
* Renal failure (eGFR \<20 ml / min)
18 Years
ALL
No
Sponsors
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Herlev Hospital
OTHER
Responsible Party
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Sami Beji, MD
Medical doctor
Principal Investigators
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Sami Beji, MD
Role: PRINCIPAL_INVESTIGATOR
Herlev Hospital
Locations
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Urology department
Herlev, , Denmark
Countries
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Central Contacts
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Other Identifiers
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H-15020548
Identifier Type: -
Identifier Source: org_study_id
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