Thulium Fiber Laser En-bloc Resection vs Conventional Transurethral Resection of Non-muscle-invasive Bladder Cancer
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|ClinicalTrials.gov Identifier: NCT04110483|
Recruitment Status : Completed
First Posted : October 1, 2019
Last Update Posted : February 18, 2020
Ongoing efforts aim at overcoming the challenges of conventional transurethral resection of bladder tumor (TURBT) such as the high recurrence rate, difficulty of pathologic interpretation and complications including wall injury. Possible advantages may have en bloc resection of bladder tumor which was previously shown to be effective and safe technique. Use of novel thulium-fiber laser may also provide additional safety and efficacy of the resection.
Objective. To prospective assess the safety and efficacy of Thulium-fiber en bloc resection of bladder tumor (Tm-fiber-ERBT) compared to TURBT.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Procedure: Thulium fiber laser en-bloc resection of non-muscle-invasive bladder cancer Procedure: Transurethral resection of non-muscle-invasive bladder cancer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Short-term Oncological Outcomes of Thulium Fiber Laser En-bloc Resection of Non-muscle-invasive Bladder Cancer|
|Actual Study Start Date :||January 1, 2015|
|Actual Primary Completion Date :||December 31, 2018|
|Actual Study Completion Date :||December 31, 2018|
Active Comparator: TURBT
A step-by-step resection of a tumor. Firstly, visible tumor is resected, then resection continues to the apparently normal mucosa on the border of the tumor, than resection of the muscle layer at the base of the tumor is performed until normal muscle fibers are visible.
Procedure: Transurethral resection of non-muscle-invasive bladder cancer
After cystoscopy and determining tumor topography, a step-by-step resection of a tumor is done. Firstly, visible tumor is resected, then resection continues to the apparently normal mucosa on the border of the tumor, than resection of the muscle layer at the base of the tumor is performed until normal muscle fibers are visible.
Experimental: Tm-fiber ERBT
A circumferential incision around the tumor is made in the visually intact bladder mucosa. After that, the incision is continued deeper into the muscular layer. Than the surgeon resects the base of the tumor with the muscular layer using traction and incisions of the muscle fibers.
Procedure: Thulium fiber laser en-bloc resection of non-muscle-invasive bladder cancer
After cystoscopy and determining tumor topography, a circumferential incision around the tumor is made in the visually intact bladder mucosa (approximately 10 mm from the edges of the tumor). It allows for accurate morphological evaluation of the surgical margin. After that, the incision is continued deeper into the muscular layer. Having identified the layer, the surgeon resects the base of the tumor with the muscular layer using traction and incisions of the muscle fibers. Making incisions in the muscular layer requires precision, a full bladder and adequate guidance with visualization techniques. Traction may be employed with the help of the tip of the resectoscope or working element. After complete tumor resection, local hemostasis was performed.
- Recurrence-free survival rate [ Time Frame: 3 month ]Absence of cancer at the site of previous resection on histological examination after re-biopsy
- Detrusor presence in the specimen [ Time Frame: 1 day after the surgery ]The presence of muscle fibers in specimens on histological investigation
- Complications [ Time Frame: up to 1 year ]Rate of postoperative complications, their severity according Clavien-Dindo score
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04110483
|Clinic of Urology, Sechenov University|
|Moscow, Russian Federation, 119991|
|Principal Investigator:||Dmitry Enikeev, M.D., Ph.D.||Sechenov University|