En Bloc Bladder Tumor Resection: Prospective Randomized Study

January 13, 2021 updated by: Alberto Breda, Fundacio Puigvert

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: En bloc
En bloc transurethral resection of the bladder
Procedure: En bloc transurethral resection of bladder tumor (TURBT)
En bloc transurethral resection of bladder tumor using thulium:yttrium aluminium garnet, monopolar and bipolar energy
Active Comparator: Conventional
Conventional transurethral resection of the bladder
Procedure: Conventional TURBT
Conventional transurethral resection of bladder tumor using monopolar and bipolar energy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Staging of bladder tumor
Time Frame: Three years
Evaluation of muscle presence in the specimen
Three years

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacio Puigvert

Collaborators

KARL STORZ Endoscopy-America, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Anticipated)

June 1, 2021

Study Completion (Anticipated)

April 1, 2026

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 13, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/09c

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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