Overview

Value of Immediate Post-operative Intravesical Epirubicin in Intermediate&High Risk Non Muscle Invasive Bladder Cancer

Status:
Completed
Trial end date:
2017-05-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mansoura University
Treatments:
Doxorubicin
Epirubicin
Criteria
Inclusion Criteria:

- 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 Criteria:

- 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.