En-Bloc Resection of Bladder Tumors

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2022-07-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Observational data shows that "en bloc" resection of bladder tumor (EBR-BT) may entail advantages when compared with conventional transurethral bladder tumor resection (TURBT). EBR-BT has the potential to increase the rate of correct staging and accurate assignment of risk-classification in non-muscle-invasive bladder cancer (NMIBC) and to avoid re-TURBT in a considerable number of high-grade NMIBC by demonstrating total macro and microscopic eradication of the primary tumor and to provide the basis for a correct treatment based on a correct stage.

Following the rules of the IDEAL collaboration evaluation and stages of surgical innovation and considering EBR-BT as a surgical technical innovation, the investigators designed a multi-institutional, stage 2a/b study on feasibility (procedural success), safety (including pathology features), and short-term efficacy of EBR-BT and as proof of concept on the reliability of NMIBC staging.

Main objective: to prospectively assess the pathological efficacy of EBR-BT in the staging of bladder cancer and the clinical efficacy at short-term recurrence-free survival.

Secondary objectives: To assess the clinical efficacy at short-term (3-months) of EBR-BT, and to compare efficacy in the staging of the EBR-BT with the conventional TURBT.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

En Bloc Bladder Tumor Resection: Prospective Randomized Study

NCT04712201

Urothelial Carcinoma Bladder Bladder Cancer

RECRUITING NA

Transurethral En Bloc Versus Standard Resection of Bladder Tumour

NCT02993211

Bladder Cancer

COMPLETED NA

Histopathological Findings in En-Bloc vs Conventional Transurethral Resection of Bladder Tumors.

NCT07259798

Urinary Bladder Cancer

COMPLETED NA

Transurethral Modified En Bloc Resection For Large Bladder Tumours.

NCT04081246

Bladder Cancer Bladder Neoplasm Bladder Tumor

RECRUITING NA

En-bloc Transurethral Resection of Bladder Tumor (En-bloc TURBT) Specimens Using a Redesigned Surgical Resectoscope Device

NCT04235764

Bladder Cancer

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

En-bloc resection of bladder tumors (EBR-BT) has been showing certain advantages over conventional transurethral resection technique (TURBT) in non-muscle-invasive bladder cancer. These advantages consist mainly in the reduction of obturator nerve reflex and obtention of surgical samples according to oncological principles. Advantages in terms of tumor recurrence in the short-term, when compared with TURBT, remain uncertain. Herein several randomized control trials aim to assess comparative outcomes in the short and long term.

A higher rate of detrusor muscle is found in the EBR-BT samples than in the conventional samples resulting in a better staging and at least theoretically the need for fewer re-TURBT indications. However, a detailed and scrupulous description of the histopathological samples is lacking and, it is assumed that the presence of detrusor in the sample without solution of continuity with submucosa and tumor is sufficient to stage. As in surgical samples of other organs, the objective of EBR-RT is not only to obtain detrusor, but also clean margins that ensure the radicality of the tumor.

The hypothesis of the investigators' is that EBR-BT will results in an increased rate of pathological specimen with the presence of detrusor muscle and free-tumor margins, hence a more accurate stage than TURBT and a decrease in 3-months recurrence at short-term (3 months)

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bladder Neoplasm

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

En Bloc Resection Bladder Tumor (Any energy source)

Patients with suspicion of NMIBC (primary or recurrent) that underwent en bloc resection (EBRT

Group Type EXPERIMENTAL

En Bloc Resection

Intervention Type PROCEDURE

En bloc transurethral resection of bladder tumor (EBR-BT) using any energy source (laser and bipolar or monopolar energy)

Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)

Patients with suspicion of NMIBC (primary or recurrent) that underwent conventional TURBT

Group Type ACTIVE_COMPARATOR

Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)

Intervention Type PROCEDURE

Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

En Bloc Resection

En bloc transurethral resection of bladder tumor (EBR-BT) using any energy source (laser and bipolar or monopolar energy)

Intervention Type PROCEDURE

Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age: 18 years old and older (adult, older adult) Sexes: All Accepts healthy volunteers: No

* Patients aged 18 and older presenting with suspicion of primary or recurrent Non-muscle invasive bladder cancer (NMIBC)
* Tumor size estimated by cystoscopy ≤ 3 cm
* Solitary or multiple tumors (up to 3 in number)

Exclusion Criteria

* Tumor size \> 3 cm of maximum dimeter
* Patient with severe systemic disease (ASA III+)
* Location on the anterior bladder wall and/ or anterior bladder neck (relative contraindication depending on accessibility)
* Pregnancy
* Histological diagnosis other than NMIBC urothelial bladder cancer
* Presence or history of previous upper-tract urinary cancer (UTUC)
* Presence of positive cytology without macroscopic identifiable bladder tumor
* Life expectancy \< 1 year
* Non-reversible coagulopathy
* Bladder tumor detected during intravesical BCG therapy
* Tumor multiplicity (\> 3 tumors)

Contacts and locations:

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No