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Single dose of Gemcitabine versus Mitomycin C in NMIBC patients after TURBT

Role of Intravesical Gemcitabine versus Mitomycin C as Immediate Intravesical Therapy post TURBT in Non-Muscle Invasive Bladder Cancer: A Prospective Exploratory Observational Study - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/01/079010
Enrollment
100
Registered
2025-01-20
Start date
Unknown
Completion date
Unknown
Last updated
2025-02-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C67- Malignant neoplasm of bladder

Interventions

Intervention1: Intravesical Gemcitabine: Immediate single time Intravesical instillation with a hold up time of 1 hour post TURBT in the post operative period in Non-Muscle Invasive Bladder Cancer Co

Sponsors

Akhilesh Sharma
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: More than equal to 18 years of age Patient providing written informed consent Cystoscopically looking NMIBC Cystoscopically complete resection of tumour done

Exclusion criteria

Exclusion criteria: Active significant Haematuria in the post operative period Bladder Perforation Extensive Resection done Previously proven MIBC patients Any high grade or more than two low grade NMIBC in the last 18 months Previous or concurrent upper urinary tract or prostatic urethral cancer Pregnant or lactating women

Design outcomes

Primary

MeasureTime frame
To evaluate the recurrence rates at the end of 6 months with Intravesical Gemcitabine and Mitomycin C as Immediate Intravesical Therapy post TURBT in Non-Muscle Invasive Bladder Cancer patients.Timepoint: At the end of 6 months after single dose of Intravesical Gemcitabine and Mitomycin C post TURBT in Non-Muscle Invasive Bladder Cancer patients

Secondary

MeasureTime frame
To study the treatment related Adverse effects with the use of Intravesical Gemcitabine & Mitomycin C as Immediate Intravesical Therapy post TURBTTimepoint: Post instillation of drug on Post Operative Day One & subsequent follow up till 6 months

Countries

India

Contacts

Public ContactAkhilesh Sharma

AIIMS Rishikesh

vikas.uro@aiimsrishikesh.edu.in8427040755

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026