En Bloc Bladder Tumor Resection: Prospective Randomized Study

NCT04712201 | Recruiting

• 1 other identifier: 2017/09c
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

TURBT; En bloc; Urothelial cancer

Outcome Measures

Primary Outcomes (1)

• Staging of bladder tumor

  Evaluation of muscle presence in the specimen

  Three years

Secondary Outcomes (8)

• Intraoperative complications

  Three years

• Rate of planned adjuvant treatment

  Three years

• Post-operative complications

  Three years

• Substaging T1 bladder cancer

  Three years

• Recurrence-free survival

  Through study completion, an average of five years

Study Arms (2)

En bloc

EXPERIMENTAL

En bloc transurethral resection of the bladder

Procedure: En bloc transurethral resection of bladder tumor (TURBT)

Conventional

ACTIVE COMPARATOR

Conventional transurethral resection of the bladder

Procedure: Conventional TURBT

Interventions

En bloc transurethral resection of bladder tumor (TURBT) PROCEDURE

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

En bloc

Conventional TURBT PROCEDURE

Conventional transurethral resection of bladder tumor using monopolar and bipolar energy

Conventional

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundacio Puigvert: lead
• KARL STORZ Endoscopy-America, Inc.: collaborator

Study Sites (1)

Fundacio Puigvert

Barcelona, 08025, Spain

RECRUITING

Related Publications (1)

• 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.

  PMID: 35618567 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Central Study Contacts

Andrea Gallioli, MD

CONTACT

0034934169730; agallioli@fundacio-puigvert.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Uro-Oncology Division and Kidney Transplant Unit

Study Record Dates

• First Submitted: January 12, 2021
• First Posted: January 15, 2021
• Study Start: April 1, 2018
• Primary Completion: June 1, 2021
• Study Completion: April 1, 2026
• Last Updated: January 15, 2021

Record last verified: 2021-01

Locations

ES (1)