En Bloc Bladder Tumor Resection: Prospective Randomized Study

Not Applicable

Recruiting

• Conditions: Urothelial Carcinoma Bladder; Bladder Cancer
• Interventions: Procedure: Conventional TURBT; Procedure: En bloc transurethral resection of bladder tumor (TURBT)

• Registration Number: NCT04712201
• Lead Sponsor: Fundacio Puigvert

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Status Verified: 2021-01
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-13
• Last Update Submitted: 2021-01-13
• Study First Posted: 2021-01-15
• Last Update Posted: 2021-01-15
• Primary Completion: 2021-06-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional	Conventional TURBT	Conventional transurethral resection of the bladder
En bloc	En bloc transurethral resection of bladder tumor (TURBT)	En bloc transurethral resection of the bladder

Primary Outcome Measures

Name	Time	Method
Staging of bladder tumor	Three years	Evaluation of muscle presence in the specimen

Secondary Outcome Measures

Name	Time	Method
Post-operative complications	Three years	Post-operative complications according to Clavien-Dindo System
Substaging T1 bladder cancer	Three years	T1a, T1b and T1c
Progression-free survival	Through study completion, an average of five years	Progression of bladder cancer
Intraoperative complications	Three years	Bladder perforation grading, obturatory reflex, conversions to conventional TURB
Disease-free survival	Through study completion, an average of five years	Disease-free survival
Cancer specific survival	Through study completion, an average of five years	Cancer specific survival
Recurrence-free survival	Through study completion, an average of five years	Recurrence of bladder cancer
Rate of planned adjuvant treatment	Three years	Rate of planned postoperative single instillation of mitomycin/epirubicin

Trial Locations

Locations (1)

Fundacio Puigvert; 🇪🇸 Barcelona, Spain