Status:
COMPLETED
Value of Immediate Post-operative Intravesical Epirubicin in Intermediate&High Risk Non Muscle Invasive Bladder Cancer
Lead Sponsor:
Mansoura University
Conditions:
Carcinoma of Urinary Bladder, Superficial
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The aim of the study is to test the value of immediate post-operative intravesical instillation of epirubicin in patients with intermediate and high risk non muscle invasive bladder cancer (NMIBC).
Detailed Description
Preoperative evaluation will be carried out in the form of routine laboratory investigations, abdominal and pelvic US and computed tomography (CT) or magnetic resonance imaging (MRI) abdomen and pelvi...
Eligibility Criteria
Inclusion
- Ability to give informed consent.
- Patients with primary or recurrent papillary Non muscle invasive bladder cancer (NMIBC).
- Complete transurethral resection of bladder tumor(TURBT).
- Normal cardiac, hematological, and renal functions.
- Patients with intermediate and high risk NMIBC confirmed by histopathology.
Exclusion
- Inability to give informed consent.
- Patients with history of previous radiotherapy or systemic chemotherapy.
- Patients suffering from immuno-deficiency or other malignancies.
- Patients with history of hypersensitivity reaction to epirubicin.
- Examination under anesthesia (EUA) reveals palpable bladder mass.
- Patients with primary, single, less than 1cm papillary bladder tumor (high likelihood of being low risk).
- Suspicion of perforation of the bladder during TURBT.
- Patients who develop hematuria in the recovery room necessitating continuous bladder wash or endoscopic haemostasis.
- Patients with proven low risk NMIBC on histopathology.
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2017
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT02214602
Start Date
July 1 2014
End Date
May 1 2017
Last Update
March 22 2018
Active Locations (1)
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1
Urology and Nephrology Center
Al Mansurah, Egypt, 35516