Comparison of Pathological Outcome and Recurrence Rate Between En Bloc and Conventional Transurethral Resection of Bladder Tumor

NCT ID: NCT07347132

Last Updated: 2026-01-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-11-30

Brief Summary

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.

Conditions

Urinary Bladder Neoplasms; Non-muscle Invasive Bladder Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

En Bloc Transurethral Resection of Bladder Tumor

Intervention Type: PROCEDURE

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.

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.

Group Type: ACTIVE_COMPARATOR

Conventional Transurethral Resection of Bladder Tumor

Intervention Type: PROCEDURE

Piecemeal endoscopic resection of a non-muscle invasive bladder tumour by removing the lesion in multiple pieces, as per standard conventional technique.

Interventions

En Bloc Transurethral Resection of Bladder Tumor

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.

Intervention Type: PROCEDURE

Conventional Transurethral Resection of Bladder Tumor

Piecemeal endoscopic resection of a non-muscle invasive bladder tumour by removing the lesion in multiple pieces, as per standard conventional technique.

Intervention Type: PROCEDURE

Other Intervention Names

En bloc resection of bladder tumour (ERBT); Conventional transurethral resection of bladder tumour (cTURBT)

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lahore General Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Muhammad Irfan Jamil

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dr Ijaz

Role: PRINCIPAL_INVESTIGATOR

Lahore General Hospital, Lahore

Locations

Lahore General Hospital, Lahore

Lahore, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

LahoreGeneralH12

Identifier Type: -

Identifier Source: org_study_id