En Bloc Bladder Tumor Resection: Prospective Randomized Study
Primary Purpose
Urothelial Carcinoma Bladder, Bladder Cancer
Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
En bloc transurethral resection of bladder tumor (TURBT)
Conventional TURBT
Sponsored by
About this trial
This is an interventional diagnostic trial for Urothelial Carcinoma Bladder focused on measuring TURBT, En bloc, Urothelial cancer
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
Sites / Locations
- Fundacio PuigvertRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
En bloc
Conventional
Arm Description
En bloc transurethral resection of the bladder
Conventional transurethral resection of the bladder
Outcomes
Primary Outcome Measures
Staging of bladder tumor
Evaluation of muscle presence in the specimen
Secondary Outcome Measures
Intraoperative complications
Bladder perforation grading, obturatory reflex, conversions to conventional TURB
Rate of planned adjuvant treatment
Rate of planned postoperative single instillation of mitomycin/epirubicin
Post-operative complications
Post-operative complications according to Clavien-Dindo System
Substaging T1 bladder cancer
T1a, T1b and T1c
Recurrence-free survival
Recurrence of bladder cancer
Progression-free survival
Progression of bladder cancer
Disease-free survival
Disease-free survival
Cancer specific survival
Cancer specific survival
Full Information
NCT ID
NCT04712201
First Posted
January 12, 2021
Last Updated
January 13, 2021
Sponsor
Fundacio Puigvert
Collaborators
KARL STORZ Endoscopy-America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT04712201
Brief Title
En Bloc Bladder Tumor Resection: Prospective Randomized Study
Official Title
En Bloc Bladder Tumor Resection: Prospective Randomized Evaluation of Monopolar, Bipolar and Laser Energy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
June 1, 2021 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fundacio Puigvert
Collaborators
KARL STORZ Endoscopy-America, Inc.
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urothelial Carcinoma Bladder, Bladder Cancer
Keywords
TURBT, En bloc, Urothelial cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
En bloc
Arm Type
Experimental
Arm Description
En bloc transurethral resection of the bladder
Arm Title
Conventional
Arm Type
Active Comparator
Arm Description
Conventional transurethral resection of the bladder
Intervention Type
Procedure
Intervention Name(s)
En bloc transurethral resection of bladder tumor (TURBT)
Intervention Description
En bloc transurethral resection of bladder tumor using thulium:yttrium aluminium garnet, monopolar and bipolar energy
Intervention Type
Procedure
Intervention Name(s)
Conventional TURBT
Intervention Description
Conventional transurethral resection of bladder tumor using monopolar and bipolar energy
Primary Outcome Measure Information:
Title
Staging of bladder tumor
Description
Evaluation of muscle presence in the specimen
Time Frame
Three years
Secondary Outcome Measure Information:
Title
Intraoperative complications
Description
Bladder perforation grading, obturatory reflex, conversions to conventional TURB
Time Frame
Three years
Title
Rate of planned adjuvant treatment
Description
Rate of planned postoperative single instillation of mitomycin/epirubicin
Time Frame
Three years
Title
Post-operative complications
Description
Post-operative complications according to Clavien-Dindo System
Time Frame
Three years
Title
Substaging T1 bladder cancer
Description
T1a, T1b and T1c
Time Frame
Three years
Title
Recurrence-free survival
Description
Recurrence of bladder cancer
Time Frame
Through study completion, an average of five years
Title
Progression-free survival
Description
Progression of bladder cancer
Time Frame
Through study completion, an average of five years
Title
Disease-free survival
Description
Disease-free survival
Time Frame
Through study completion, an average of five years
Title
Cancer specific survival
Description
Cancer specific survival
Time Frame
Through study completion, an average of five years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Gallioli, MD
Phone
0034934169730
Email
agallioli@fundacio-puigvert.es
Facility Information:
Facility Name
Fundacio Puigvert
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Gallioli, MD
Phone
0034934169730
Email
agallioli@fundacio-puigvert.es
12. IPD Sharing Statement
Citations:
PubMed Identifier
35618567
Citation
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.
Results Reference
derived
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En Bloc Bladder Tumor Resection: Prospective Randomized Study
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