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En-Bloc Resection of Bladder Tumors

NCT04784507 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-04-12

No results posted yet for this study

Summary

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.

Conditions

  • Bladder Neoplasm

Interventions

PROCEDURE

En Bloc Resection

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

PROCEDURE

Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)

Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)

Sponsors & Collaborators

  • Bağcılar Eğitim ve Araştırma Hastanesi

    collaborator UNKNOWN

  • Betul Kartal

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-01
Primary Completion
2022-05-31
Completion
2022-07-30

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04784507 on ClinicalTrials.gov