En-Bloc Resection of Bladder Tumors
1 other identifier
interventional
60
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Apr 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2020
CompletedFirst Submitted
Initial submission to the registry
February 26, 2021
CompletedFirst Posted
Study publicly available on registry
March 5, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
July 30, 2022
CompletedApril 12, 2022
April 1, 2022
2.2 years
February 26, 2021
April 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Pathological Staging
Staging of NMIBC is defined by the presence of sufficient detrusor in the EBR-BT specimens, the status of the margins, presence of a tumor and /or CIS in the mucosal margins, the status of the detrusor margin, and suspicion of instability in mucosa free of tumor.
Immediately after the intervention
Recurrence at 3 months
Recurrence free survival at 3-months (absence of visible tumors at the site of the previous resection
3 months
Secondary Outcomes (2)
Operative Complications
intraoperative
Perioperative Complications
Up to 90 days
Study Arms (2)
En Bloc Resection Bladder Tumor (Any energy source)
EXPERIMENTALPatients with suspicion of NMIBC (primary or recurrent) that underwent en bloc resection (EBRT
Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)
ACTIVE COMPARATORPatients with suspicion of NMIBC (primary or recurrent) that underwent conventional TURBT
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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:
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Betul Kartallead
- Bağcılar Eğitim ve Araştırma Hastanesicollaborator
Study Sites (2)
Bagcilar Education and Research Hospital
Istanbul, Bagcilar, 34200, Turkey (Türkiye)
Medipol Mega University Hospital
Istanbul, Bagcilar, 34214, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Coordinator
Study Record Dates
First Submitted
February 26, 2021
First Posted
March 5, 2021
Study Start
April 1, 2020
Primary Completion
May 31, 2022
Study Completion
July 30, 2022
Last Updated
April 12, 2022
Record last verified: 2022-04