En Bloc Bladder Tumor Resection: Prospective Randomized Study

NCT ID: NCT04712201

Last Updated: 2021-01-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2026-04-01

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.

Conditions

Urothelial Carcinoma Bladder; Bladder Cancer

Study Design

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

Study Groups

En bloc

En bloc transurethral resection of the bladder

Group Type: EXPERIMENTAL

En bloc transurethral resection of bladder tumor (TURBT)

Intervention Type: PROCEDURE

En bloc transurethral resection of bladder tumor using thulium:yttrium aluminium garnet, monopolar and bipolar energy

Conventional

Conventional transurethral resection of the bladder

Group Type: ACTIVE_COMPARATOR

Conventional TURBT

Intervention Type: PROCEDURE

Conventional transurethral resection of bladder tumor using monopolar and bipolar energy

Interventions

En bloc transurethral resection of bladder tumor (TURBT)

En bloc transurethral resection of bladder tumor using thulium:yttrium aluminium garnet, monopolar and bipolar energy

Intervention Type: PROCEDURE

Conventional TURBT

Conventional transurethral resection of bladder tumor using monopolar and bipolar energy

Intervention Type: PROCEDURE

Eligibility 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

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

Sponsors

KARL STORZ Endoscopy-America, Inc.

INDUSTRY

Sponsor Role: collaborator

Fundacio Puigvert

OTHER

Sponsor Role: lead

Responsible Party

Alberto Breda

Chief of the Uro-Oncology Division and Kidney Transplant Unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Fundacio Puigvert

Barcelona, , Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Andrea Gallioli, MD

Role: CONTACT

agallioli@fundacio-puigvert.es

0034934169730

Facility Contacts

Andrea Gallioli, MD

Role: primary

agallioli@fundacio-puigvert.es

0034934169730

References

Gallioli A, Diana P, Fontana M, Territo A, Rodriguez-Faba O, Gaya JM, Sanguedolce F, Huguet J, Mercade A, Piana A, Aumatell J, Bravo-Balado A, Algaba F, Palou J, Breda A. En Bloc Versus Conventional Transurethral Resection of Bladder Tumors: A Single-center Prospective Randomized Noninferiority Trial. Eur Urol Oncol. 2022 Aug;5(4):440-448. doi: 10.1016/j.euo.2022.05.001. Epub 2022 May 23.

Reference Type: DERIVED

PMID: 35618567 (View on PubMed)

Other Identifiers

2017/09c

Identifier Type: -

Identifier Source: org_study_id