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

NCT ID: NCT03221062

Last Updated: 2017-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-08-01
• Study Completion Date: 2021-07-31

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.

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Laser en Bloc Resection

Laser en Bloc Resection of bladder tumor(laser ERBT)

Group Type: EXPERIMENTAL

Laser en Bloc Resection

Intervention Type: DEVICE

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

Hydroknife en Bloc Resection

Hydroknife en Bloc Resection of bladder tumor (Hydroknife ERBT)

Group Type: EXPERIMENTAL

Laser en Bloc Resection

Intervention Type: DEVICE

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

conventional transurethral resection

conventional transurethral resection of bladder tumor(cTURBT)

Group Type: EXPERIMENTAL

Laser en Bloc Resection

Intervention Type: DEVICE

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

Interventions

Laser en Bloc Resection

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

Intervention Type: DEVICE

Other Intervention Names

Hydroknife en Bloc Resection; conventional transurethral resection

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tongji Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jia Hu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Jia Hu, MD PhD

Role: CONTACT

jiahutjm@163.com

+86 13986089626

Other Identifiers

JHu

Identifier Type: -

Identifier Source: org_study_id