Neoplasms

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

En bloc transurethral resection of the bladder

Conventional transurethral resection of the bladder

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

En bloc transurethral resection of bladder tumor (TURBT)

Conventional transurethral resection of bladder tumor using monopolar and bipolar energy

Conventional TURBT

Andrea Gallioli, MD

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.

En Bloc Bladder Tumor Resection: Prospective Randomized Study

En Bloc Bladder Tumor Resection: Prospective Randomized Evaluation of Monopolar, Bipolar and Laser Energy

Evaluation of muscle presence in the specimen

Bladder perforation grading, obturatory reflex, conversions to conventional TURB

Rate of planned postoperative single instillation of mitomycin/epirubicin

Post-operative complications according to Clavien-Dindo System

KARL STORZ Endoscopy-America, Inc.

Fundacio Puigvert

Chief of the Uro-Oncology Division and Kidney Transplant Unit

Non-Muscle Invasive Bladder Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

The bladder tumour will be resected en bloc and removed in total, if possible.

The bladder tumour will be removed by conventional piecemeal resection.

Tumour is resected and removed from the bladder in one piece, if possible.

En Bloc resection

Conventional TURB

Jørgen Bjerggaard J, Professor MD

Ninna Kjær Nielsen, MD

Knud Fabrin, MD

Gitte W Lam, MD

Kasper Olsen, MD

Per Holt, MD

Juan Luis Vásquez, MD

Egils Vjaters

Karlis Kaufmanis

Erik Haug, MD

Aim: To compare the surgical method of En Bloc resection to the conventional transurethral resection of non-muscle invasive bladder cancer (NMIBC) in terms of complete removal of tumour, specimen quality, and pathological certainty.

Background: NMIBC is a common disease with a 5-year recurrence rate reported as high as 64%. The cornerstone in the treatment of NMIBC is transurethral resection (TURB) where the tumour is dissected in pieces, removed from the bladder, and pathologically examined for potential muscle invasion. As the tumour is fragmented before removal, the method violates basic oncological principles and compromises pathological examination. Hence, TURB is possibly part of the mechanism causing recurrences. En Bloc resection (EBR), where the tumour is removed in toto, can potentially overcome the flaws of conventional TURB, but large randomized trials are needed.

Methods: This project will be a multicentre randomised controlled clinical trial comparing EBR to conventional TURB. Patients with suspected NMIBC tumours with largest tumour diameter ≥1cm and ≤6cm will be randomised to either the intervention group, thus undergoing EBR, or the control group, undergoing conventional TURB. The investigators intend to include 220 patients in total, 110 patients in each group. The RCT will be initiated in 2022.

Perspectives: If EBR can be shown to remove bladder tumours with better pathological quality and certainty, this could potentially spare patients from undergoing surgeries in the future, thereby reducing costs for both patients and society.

En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer

Proportion of patients with unaltered pathological T-stage following central pathology revision, reTURB, or cystectomy compared to initial T-stage description from TURB.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
En Bloc Bladder Tumor Resection: Prospective Randomized Study	NCT04712201	Urothelial Carc... Bladder Cancer	En bloc transur... Conventional TU...	18 Years -	Fundacio Puigvert
En Bloc Bladder Tumor Resection: Prospective Randomized Study	NCT04712201	Urothelial Carc... Bladder Cancer	En bloc transur... Conventional TU...	18 Years -	Fundacio Puigvert
En Bloc Transurethral Resection of Non-muscle Invasive Bladder Cancer	NCT05223491	Non-muscle Inva...	En Bloc resecti... Conventional TU...	18 Years -	Aarhus University Hospital
En Bloc Bladder Tumor Resection: Prospective Randomized Study	NCT04712201	Urothelial Carc... Bladder Cancer	En bloc transur... Conventional TU...	18 Years -	Fundacio Puigvert

Spots Global Cancer Trial Database for en bloc

Every month we try and update this database with for en bloc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for en bloc

Every month we try and update this database with for en bloc cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for en bloc cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.