- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07347132
Comparison of Pathological Outcome and Recurrence Rate Between En Bloc and Conventional Transurethral Resection of Bladder Tumor
Bladder cancer that has not invaded the bladder muscle often returns after treatment, creating repeated procedures and ongoing anxiety for patients. The standard initial treatment is transurethral resection of bladder tumour (TURBT), in which visible tumours are removed through a telescope passed into the bladder. Conventional TURBT usually removes the tumour in multiple pieces, which may reduce specimen quality for laboratory assessment and may increase the chance that small tumour fragments remain or spread during removal. En bloc TURBT is a newer technique that aims to remove the tumour in one intact piece, which may improve the quality of the tissue specimen for accurate staging and grading, allow better assessment of surgical margins, and potentially reduce recurrence.
This randomized controlled trial was conducted in the Department of Urology, Lahore General Hospital and PGMI, Lahore. A total of 116 adults (18 to 60 years) with non-muscle invasive bladder cancer were enrolled and randomly assigned to en bloc TURBT or conventional TURBT (58 patients per group). Resected specimens were evaluated by pathologists who was not be informed of the surgical technique. The study was compare key pathological outcomes, including the presence of detrusor muscle in the specimen, histological grade, tumour stage accuracy, specimen integrity, and the ability to assess lateral and deep resection margins. Participants were followed for 15 months, with surveillance at 3-month intervals.
Study Overview
Status
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Lahore General Hospital, Lahore
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Both male and female patients between 18 years and 60 years of age.
- Patients diagnosed with non-muscle invasive bladder cancer (NMIBC).
- Willingness to participate in the study, as indicated by signed informed consent.
Exclusion Criteria:
- Patients with muscle-invasive bladder cancer (MIBC) or metastatic disease.
- Previous history of bladder cancer treatment, including surgical resection or chemotherapy.
- Patients with contraindications to anesthesia or those unable to undergo TURBT due to medical reasons. iv. Individuals who have not provided informed consent or are unable to comply with follow-up requirements.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: En Bloc Transurethral Resection of Bladder Tumor (En Bloc TURBT)
Participants were undergo complete removal of the bladder tumour as a single intact specimen (en bloc), including both exophytic and endophytic components, for tumours up to 1.5 cm in size.
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Complete en bloc endoscopic resection of a non-muscle invasive bladder tumour (≤1.5 cm) as one piece, aiming to preserve specimen integrity and allow assessment of deep and lateral margins.
Other Names:
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Active Comparator: Conventional Transurethral Resection of Bladder Tumor (Conventional TURBT)
Participants were undergo conventional piecemeal transurethral resection of the bladder tumour, in which the tumour is removed in multiple fragments.
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Piecemeal endoscopic resection of a non-muscle invasive bladder tumour by removing the lesion in multiple pieces, as per standard conventional technique.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Tumor Recurrence Rate
Time Frame: Up to 15 months after surgery, assessed at 3, 6, 9, 12 and 15 months
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Proportion of participants with histologically confirmed recurrence of non-muscle invasive bladder cancer detected by cystoscopy and biopsy after complete initial resection.
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Up to 15 months after surgery, assessed at 3, 6, 9, 12 and 15 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr Ijaz, Lahore General Hospital, Lahore
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Pathologic Processes
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Disease Attributes
- Neoplasms by Histologic Type
- Neoplasms, Glandular and Epithelial
- Urologic Neoplasms
- Carcinoma
- Urinary Bladder Diseases
- Pathological Conditions, Signs and Symptoms
- Non-Muscle Invasive Bladder Neoplasms
- Recurrence
- Urinary Bladder Neoplasms
Other Study ID Numbers
- LahoreGeneralH12
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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