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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
Sponsor:
Information provided by (Responsible Party):
Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University

Tracking Information
First Submitted Date  ICMJE September 25, 2019
First Posted Date  ICMJE October 1, 2019
Last Update Posted Date February 18, 2020
Actual Study Start Date  ICMJE January 1, 2015
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 14, 2020)
Recurrence-free survival rate [ Time Frame: 3 month ]
Absence of cancer at the site of previous resection on histological examination after re-biopsy
Original Primary Outcome Measures  ICMJE
 (submitted: September 27, 2019)
Recurrence-free survival rate [ Time Frame: 3 month ]
Tumor regrowth rate at the site of previous resection
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 14, 2020)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2019)
  • Detrusor presence in the specimen [ Time Frame: 1 day after the surgery ]
    The presence of muscle fibers in specimens
  • Complications [ Time Frame: up to 1 year ]
    Postoperative complications
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Thulium Fiber Laser En-bloc Resection vs Conventional Transurethral Resection of Non-muscle-invasive Bladder Cancer
Official Title  ICMJE Safety and Short-term Oncological Outcomes of Thulium Fiber Laser En-bloc Resection of Non-muscle-invasive Bladder Cancer
Brief Summary

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.

Detailed Description En bloc resection of bladder tumor (ERBT) was first employed by Kawada T. et al. in 1997. The technique showed promising results in terms of safety and tumor staging. Development of laser surgery and emergence of the holmium (Ho:YAG) and later thulium (Tm:YAG) lasers in the 1990s enabled laser ERBT with subsequent studies demonstrating high efficacy and safety of the new techniques. Ho:YAG and Tm:YAG ERBT have distinct advantages over conventional TURBT such as the complete absence of the obturator nerve reflex and hence, lower risks of perforation or bleeding as well as a higher quality specimens for pathologic examination, due to lack of the cautery effect. Recently, a new type of thulium laser was developed - that allows to decrease the penetration depth less than 0.15 mm, which is two times less than that of Tm:YAG. Another advantage is the decreased carbonization compared to Tm:YAG due to better water absorption of laser energy. All these aspects make Tm:YAG a precise tool that may improve the resection quality resulting in better management. Data on laser ERBT of NMIBC with Tm:YAG is limited and that on Tm-fiber laser ERBT is absent altogether. The investigators hypothesized that Tm-fiber laser ERBT would result in a lower probability of adverse events and better recurrence-free survival compared to conventional TURBT.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Bladder Cancer
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Transurethral resection of non-muscle-invasive bladder cancer
  • 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.
    Intervention: Procedure: Thulium fiber laser en-bloc resection of non-muscle-invasive bladder cancer
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2019)
130
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 31, 2018
Actual Primary Completion Date December 31, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

• Primary Ta or T1 bladder cancer (NMIBC)

Exclusion Criteria:

• Pure carcinoma in situ

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04110483
Other Study ID Numbers  ICMJE Sechenov-ERBT-16
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dmitry Enikeev, MD, PhD, I.M. Sechenov First Moscow State Medical University
Study Sponsor  ICMJE I.M. Sechenov First Moscow State Medical University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dmitry Enikeev, M.D., Ph.D. Sechenov University
PRS Account I.M. Sechenov First Moscow State Medical University
Verification Date February 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP