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

NCT03221062 | Unknown Phase 4

• 1 other identifier: JHu
• Study Type: interventional
• Target: 180
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Non-muscle Invasive Bladder Cancer

Outcome Measures

Primary Outcomes (2)

• The pathological staging assessment

  The pathological staging assessment for ERBT or cTURBT procedure

  one week

• The recurrence rate assessment at resection sites

  The recurrence rate assessment at resection sites for ERBT or cTURBT procedure

  two year

Secondary Outcomes (1)

• periprocedure complications

  2 days

Study Arms (3)

Laser en Bloc Resection

EXPERIMENTAL

Laser en Bloc Resection of bladder tumor(laser ERBT)

Device: Laser en Bloc Resection

Hydroknife en Bloc Resection

EXPERIMENTAL

Hydroknife en Bloc Resection of bladder tumor (Hydroknife ERBT)

Device: Laser en Bloc Resection

conventional transurethral resection

EXPERIMENTAL

conventional transurethral resection of bladder tumor(cTURBT)

Device: Laser en Bloc Resection

Interventions

Laser en Bloc Resection DEVICE

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

Also known as: Hydroknife en Bloc Resection, conventional transurethral resection

Hydroknife en Bloc Resection; Laser en Bloc Resection; conventional transurethral resection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Pathological or histological diagnosis by cystoscopy of primary non-muscle invasive bladder urothelial carcinoma (Ta, T1);
• Imaging examinations showed the bladder muscle has not been affected, no lymph node metastasis or distant metastasis;
• Diameter of tumor 1-3cm
• Number of lesions≤3 (The position of small lesions relatively concentrated as one place)
• 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

You may not qualify if:

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

Sponsors & Collaborators

• Tongji Hospital: lead

MeSH Terms

Conditions

Non-Muscle Invasive Bladder Neoplasms

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Jia Hu, MD PhD

CONTACT

+86 13986089626; jiahutjm@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 18, 2017
• Study Start: August 1, 2017
• Primary Completion: July 31, 2019
• Study Completion: July 31, 2021
• Last Updated: July 21, 2017

Record last verified: 2017-07