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

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ClinicalTrials.gov Identifier: NCT03221062
Recruitment Status : Not yet recruiting
First Posted : July 18, 2017
Last Update Posted : July 21, 2017
Sponsor:
Information provided by (Responsible Party):
Jia Hu, Tongji Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Non-muscle Invasive Bladder Cancer Device: Laser en Bloc Resection Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Estimated Study Start Date : August 1, 2017
Estimated Primary Completion Date : July 31, 2019
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: Laser en Bloc Resection
Laser en Bloc Resection of bladder tumor(laser ERBT)
Device: Laser en Bloc Resection
Procedure: Laser en Bloc Resection of bladder tumor Procedure: Hydroknife transurethral resection of bladder tumor Procedure: conventional transurethral resection
Other Names:
  • Hydroknife en Bloc Resection
  • conventional transurethral resection

Experimental: Hydroknife en Bloc Resection
Hydroknife en Bloc Resection of bladder tumor (Hydroknife ERBT)
Device: Laser en Bloc Resection
Procedure: Laser en Bloc Resection of bladder tumor Procedure: Hydroknife transurethral resection of bladder tumor Procedure: conventional transurethral resection
Other Names:
  • Hydroknife en Bloc Resection
  • conventional transurethral resection

Experimental: conventional transurethral resection
conventional transurethral resection of bladder tumor(cTURBT)
Device: Laser en Bloc Resection
Procedure: Laser en Bloc Resection of bladder tumor Procedure: Hydroknife transurethral resection of bladder tumor Procedure: conventional transurethral resection
Other Names:
  • Hydroknife en Bloc Resection
  • conventional transurethral resection




Primary Outcome Measures :
  1. The pathological staging assessment [ Time Frame: one week ]
    The pathological staging assessment for ERBT or cTURBT procedure

  2. The recurrence rate assessment at resection sites [ Time Frame: two year ]
    The recurrence rate assessment at resection sites for ERBT or cTURBT procedure


Secondary Outcome Measures :
  1. periprocedure complications [ Time Frame: 2 days ]
    Modified Clavien scale will be used for reporting and comparison of periprocedure complications(obturator nerve reflection;bladder perforation)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pathological or histological diagnosis by cystoscopy of primary non-muscle invasive bladder urothelial carcinoma (Ta, T1);
  2. Imaging examinations showed the bladder muscle has not been affected, no lymph node metastasis or distant metastasis;
  3. Diameter of tumor 1-3cm
  4. Number of lesions≤3 (The position of small lesions relatively concentrated as one place)
  5. Patients who agree to ERBT or cTURBT surgery, and will be effected to the postoperative follow-up treatment such as conventional infusion after the operation

Exclusion Criteria:

  1. Tis or non-transitional epithelial tumors
  2. Pathological or imaging examinations showed the bladder muscle has not been affected
  3. There has surgery contraindications, such as bladder fibrosis
  4. Diameter of tumor >3cm or <1cm
  5. Number of lesions>3
  6. Anteriorly located tumor
  7. Received chemotherapy or BCG perfusion therapy in the nearly 3 months
  8. Poor performance status is difficult to tolerate surgery
  9. The patient refused to sign a consent form

Information from the National Library of Medicine

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): NCT03221062


Contacts
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Contact: Jia Hu, MD PhD +86 13986089626 jiahutjm@163.com

Sponsors and Collaborators
Tongji Hospital

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Responsible Party: Jia Hu, Principal Investigator, Tongji Hospital
ClinicalTrials.gov Identifier: NCT03221062    
Other Study ID Numbers: JHu
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: July 21, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases