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"En Bloc" Resection of NMIBC: a Prospective， Single Centre，Randomized Study

NCT03221062 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2017-07-21

No results posted yet for this study

Summary

The traditional method of choice for intravesical resection of bladder tumors is conventional transurethral resection of bladder tumor (cTURBT). However, there has long been an ambition to overcome its biggest limitation, tumor fragmentation. Possible consequences include cell seeding and poor specimen quality, including missing detrusor muscle, thermal tissue damage, and tissue fragmentation. En bloc resection of bladder tumor (ERBT) represents an alternative technique for resection of bladder tumors. There is no doubt that ERBT has huge potential. ERBT provides specimens of high quality that are easy for pathologists to read. In theory, this may sustainably change the view on secondary resection, lead to faster decisions on subsequent treatments, and influence patient prognosis. Thus, there is an urgent need to compare ERBT with cTURBT in a thoroughly planned trial.

Conditions

Interventions

DEVICE

Laser en Bloc Resection

Procedure: Laser en Bloc Resection of bladder tumor Procedure: Hydroknife transurethral resection of bladder tumor Procedure: conventional transurethral resection

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-08-01
Primary Completion
2019-07-31
Completion
2021-07-31

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03221062 on ClinicalTrials.gov