Status:
UNKNOWN
En-Bloc Resection of Bladder Tumors
Lead Sponsor:
Betul Kartal
Collaborating Sponsors:
Bağcılar Eğitim ve Araştırma Hastanesi
Conditions:
Bladder Neoplasm
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 potentia...
Detailed Description
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 con...
Eligibility Criteria
Inclusion
- Age: 18 years old and older (adult, older adult) Sexes: All Accepts healthy volunteers: No
- Inclusion criteria:
- 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
- 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:
Key Trial Info
Start Date :
April 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04784507
Start Date
April 1 2020
End Date
July 30 2022
Last Update
April 12 2022
Active Locations (2)
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1
Bagcilar Education and Research Hospital
Istanbul, Bagcilar, Turkey (Türkiye), 34200
2
Medipol Mega University Hospital
Istanbul, Bagcilar, Turkey (Türkiye), 34214