NCT03221062

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

Comparison of the Pathological Stage and Clinical Outcome of en Bloc Transurethral Resection by HybridKnife or Laser Versus Conventional Transurethral Resection for NMIBC: a Prospective, Single Centre, Randomized Study

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Tongji Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Urothelial bladder cancer (UBC) represents a major worldwide healthcare challenge in western countries as well as in developing countries, both oncologically and economically. Initially, most patients present with nonmuscle invasive bladder cancer (NMIBC) with disease confined to the mucosa (stage Ta, carcinoma in situ) or submucosa (T1) characterized by a far lower mortality rate compared with muscle invasive bladder cancer (MIBC).The vast majority of newly diagnosed are non-muscle bladder cancers (NMIBC) which represents about 75% and can be treated with transurethral resection of bladder tumors (TURBT). Therefore, correct initial staging is critical. The quality of TURBT strongly determines patient prognosis and overall treatment. Conventional transurethral resection of bladder tumors (cTURBT) causes fragmentation. Possible consequences include cell seeding and poor specimen quality, including missing detrusor muscle, thermal tissue damage, and tissue fragmentation. ERBT is developing concept as an alternative to conventional TURBT. En bloc is identified by using various energy sources or modified resection loops as a promising technique. Such as HybridKnife or laser. The question has been raised as to whether ERBT is ready for guideline implementation. Only two prospective, randomized trials on ERBT have been published. However, there are details on statistical preparation, patient selection, and definitions of primary and secondry goals are missing. Thus, there is still an urgent need to compare ERBT with cTURBT in a thoroughly planned trial. This study will be conducted in a single centre at Department of Urology, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. Eligible patient presented with papillary bladder tumor will be asked to participate in this study and will be provided with an informed consent form in line with Good Clinical Practise and the Declaration of Helsinki.

Conditions

• Non-muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
DEVICE	Laser en Bloc Resection	Procedure: Laser en Bloc Resection of bladder tumor Procedure: Hydroknife transurethral resection of bladder tumor Procedure: conventional transurethral resection

Timeline

• Start date: 2017-08-01
• Primary completion: 2019-07-31
• Completion: 2021-07-31
• First posted: 2017-07-18
• Last updated: 2017-07-21