HYbrid Knife in Bladder Cancer Resection Initially Detected by Hexvix based BLUe-Light Enhancement

Not Applicable

• Conditions: C67; D09.0; Malignant neoplasm of bladder; Bladder

• Registration Number: DRKS00004414
• Lead Sponsor: niversitätsklinikum Tübingen Universitätsklinik für Urologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-07
• Study Completion: 2016-08-01
• Results First Posted: 2020-06-23
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 115

Inclusion Criteria

Non muscle-invasive bladder cancer
Diagnosed by cystoscopy, imaging technique or cytology
min. 1 lesion > 0,5 cm

Exclusion Criteria

- Age under 18 years.
- Persons who are incapable of giving consent.
- Pregnancy.
- Muscle-invasive cancer.
- Multifocal cancer > 5 lesions exceeding 0,5 cm
- Tumours which could not be resected completely with both methods (due to technical problems).
- Tumours too big to be retrieved endoscopically in one piece.
- In case of spacious CIS: Tumours which cannot be completely removed endoscopically
- Recent (6-8 weeks) instillation therapy (chemotherapeutics, BCG)
- pronounced fibrosis of the bladder (contracted bladder)
- Patients who will be treated with early installation therapy

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of specimen which can be reliably evaluated pathologically concerning muscle-invasiveness. Data will be gathered on e-questionnaires

Secondary Outcome Measures

Name	Time	Method
Percentage of en-bloc resections<br>Number each group of proven R0-status<br>In case of Re-TURB: Percentage of tumour-free Re-TURB specimen<br>Percentage of specimen of T1-tumours for which an histological subclassification was possible<br>Determination of Hexvix® tissue penetration<br>Correlation of the spatial expansion of fluorescent marked tissue and tumour-specific histological findings in the cross-sections<br>Data collection: All resected specimen will be investigated by the study-pathologist, data will be gathered on e-questionnaires. <br><br>After 12 months a PDD-cystoscopy will be conducted, recurrence and progression rate will be documented on e-questionnaires.<br>