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Laser En Bloc Resection in Bladder Cancer: Holmium vs. Thulium Trial

Safety and efficacy of Holmium Laser En Bloc resection of bladder tumor (HoLERBT) and Thulium Laser En Bloc resection of bladder tumor (ThuLERBT) in Non-Muscle Invasive Bladder Cancer: A Randomized Controlled Trial - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065452
Enrollment
80
Registered
2024-04-09
Start date
Unknown
Completion date
Unknown
Last updated
2025-12-08

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: Holmium Laser En Bloc resection of bladder tumor (HoLERBT): Procedure Overview: Preoperative Assessment: Patients meeting inclusion criteria are evaluated for fitness for anesthesia, i

Sponsors

Post Graduate Institute of Medical Education & Research, Chandigarh
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Patients with Urinary Bladder mass presenting for the first time with single tumor on imaging and the tumor size less than 4 cm.

Exclusion criteria

Exclusion criteria: 1) Patients who have received any form of intravesical/systemic chemotherapy elsewhere. 2) Patients with obvious extravesical disease on CECT (radiologically more than or equal to T3) 3) Tumor size more than 4 cm.

Design outcomes

Primary

MeasureTime frame
Efficacy of ThuLERBT in comparison with HoLERBT in tumor histopathological staging and detrusor muscle sampling for biopsy.Timepoint: operation time ,Number of growths,Morphology, Mean diameter of tumor (cm), Tumor location, Completion of resection Obturator jerk Bladder perforation (if any)

Secondary

MeasureTime frame
Periprocedural complications between ThuLERBT and HoLERBT in terms of bleeding and obturator nerve jerk.Timepoint: real-time as the interventions are being carried out;Incidence of residual tumour and tumour upstaging in restage HoLERBT / ThuLERBTTimepoint: During the postoperative period, specifically when the restaging procedures are performed

Countries

India

Contacts

Public ContactProf Dr Uttam K Mete

Postgraduate Institute of Medical Education and Research, Chandigarh, India

uttammetepgi@gmail.com7087009322

Outcome results

None listed

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