En Bloc Bladder Tumor Resection: Prospective Randomized Study

• ClinicalTrials.gov Identifier: NCT04712201
• Recruitment Status: Recruiting
• First Posted: January 15, 2021
• Last Update Posted: January 15, 2021
• Sponsor: Fundacio Puigvert
• Collaborator: KARL STORZ Endoscopy-America, Inc.
• Information provided by (Responsible Party): Alberto Breda, Fundacio Puigvert

Study Description

Brief Summary:

INTRODUCTION Bladder tumor is the second most common neoplasm in the genitourinary tract. Most cases of ex novo diagnosis of bladder cancers are present as non-invasive muscle tumors, which are treatable through endourological procedures. The current standard is based on conventional transurethral resection of bladder tumor, although high rates of recurrence have been reported following resection of the primary tumor. Given the importance of a correct initial diagnosis in these cases, en bloc transurethral resection has developed over the past 2 decades. This technique was born, according to the literature, with 3 main objectives: to improve the quality of the surgical piece for its anatomopathological reading, reduce the rate of postoperative complications and reduce the rate of relapses in the surgical bed. This technique is used as a common practice of tumor resection in other centers and has been shown in multiple publications that it does not increase surgical risk or negatively affect cancer results.

OBJECTIVE The objective of our study is to compare feasibility, perioperative complication rate, accuracy of staging and recurrence/progression rates when performing en bloc resection by means of different energies: monopolar, bipolar and laser energy.

MATERIAL AND METHODS Between April 2018 and June 2021, a prospective randomized study will be conducted including patients undergoing a transurethral resection of initial or recurrent bladder tumor, either unifocal or multifocal. Patients with tumors less than 3 cm and with less than 3 tumors shall be included if multiple. Patients with more than 3 tumors or tumors over 3cm, those with evidence of invasive muscle tumor(cT2) or those with evidence of remote metastasis, whether lymphatic or organic, will be excluded.

Patients will be randomized into two groups:

• Group 1 (test): en bloc resection (n-180). It will be divided into 3 subgroups according to the energy used (monopolar, bipolar, laser energy).
• Group 2 (control): Conventional transurethral resection (n-120). It will be divided into 2 subgroups depending on the energy used (monopolar or bipolar).

A fact sheet will be given to the patient about the study and the signature of the informed consent will be requested in order to be included. The patient will be free to leave the study at any time without having to provide any justification and without affecting the treatment, intervention and follow-up that must be carried out.

The processing and storage of samples will be carried out in the pathological anatomy laboratory, according to standard clinical practice.

Patients will be monitored according to the usual clinical practice protocol (minimum 5-year follow-up), included in the non-muscle invasive bladder tumor protocols of the Puigvert Foundation.

Condition or disease	Intervention/treatment	Phase
Urothelial Carcinoma Bladder; Bladder Cancer	Procedure: En bloc transurethral resection of bladder tumor (TURBT); Procedure: Conventional TURBT	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 300 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Diagnostic
• Official Title: En Bloc Bladder Tumor Resection: Prospective Randomized Evaluation of Monopolar, Bipolar and Laser Energy
• Actual Study Start Date: April 1, 2018
• Estimated Primary Completion Date: June 1, 2021
• Estimated Study Completion Date: April 1, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: En bloc; En bloc transurethral resection of the bladder	Procedure: En bloc transurethral resection of bladder tumor (TURBT); En bloc transurethral resection of bladder tumor using thulium:yttrium aluminium garnet, monopolar and bipolar energy
Active Comparator: Conventional; Conventional transurethral resection of the bladder	Procedure: Conventional TURBT; Conventional transurethral resection of bladder tumor using monopolar and bipolar energy

Outcome Measures

Primary Outcome Measures :

1. Staging of bladder tumor [ Time Frame: Three years ]
   Evaluation of muscle presence in the specimen

Secondary Outcome Measures :

1. Intraoperative complications [ Time Frame: Three years ]
   Bladder perforation grading, obturatory reflex, conversions to conventional TURB
2. Rate of planned adjuvant treatment [ Time Frame: Three years ]
   Rate of planned postoperative single instillation of mitomycin/epirubicin
3. Post-operative complications [ Time Frame: Three years ]
   Post-operative complications according to Clavien-Dindo System
4. Substaging T1 bladder cancer [ Time Frame: Three years ]
   T1a, T1b and T1c
5. Recurrence-free survival [ Time Frame: Through study completion, an average of five years ]
   Recurrence of bladder cancer
6. Progression-free survival [ Time Frame: Through study completion, an average of five years ]
   Progression of bladder cancer
7. Disease-free survival [ Time Frame: Through study completion, an average of five years ]
   Disease-free survival
8. Cancer specific survival [ Time Frame: Through study completion, an average of five years ]
   Cancer specific survival

Eligibility Criteria

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

Criteria

Inclusion Criteria:

• Unifocal primary or recurrent bladder cancer with size less or equal than 3 cm
• Multifocal primary or recurrent bladder cancer less or equal than 3 lesions and with size less or equal than 3 cm

Exclusion Criteria:

• Evidence of > 3 tumors or > 3 cm
• Computed tomography/cystoscopy suspect of muscle-invasive bladder cancer (cT2 or higher)
• Computed tomography/magnetic resonance evidence of distant metastases

Contacts and Locations

Contacts

Contact: Andrea Gallioli, MD; 0034934169730; agallioli@fundacio-puigvert.es

Locations

Spain

Fundacio Puigvert; Recruiting

Barcelona, Spain, 08025

Contact: Andrea Gallioli, MD 0034934169730 agallioli@fundacio-puigvert.es

Sponsors and Collaborators

Fundacio Puigvert

KARL STORZ Endoscopy-America, Inc.

More Information

• Responsible Party: Alberto Breda, Chief of the Uro-Oncology Division and Kidney Transplant Unit, Fundacio Puigvert
• ClinicalTrials.gov Identifier: NCT04712201
• Other Study ID Numbers: 2017/09c
• First Posted: January 15, 2021
• Last Update Posted: January 15, 2021
• Last Verified: January 2021

• 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

Keywords provided by Alberto Breda, Fundacio Puigvert:

TURBT; En bloc; Urothelial cancer

Additional relevant MeSH terms:

Urinary Bladder Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Urinary Bladder Diseases; Urologic Diseases