Comparing laser and traditional methods for bladder tumor removal

Safety Analysis and Oncological Outcomes in Endoscopic Bladder Tumor Resection With Laser Holmium Compared With Transurethral Resection: a Prospective and Randomized Study

This study is testing whether using a laser to remove bladder tumors is safer and more effective than the traditional method for people with bladder cancer.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Instituto do Cancer do Estado de São Paulo (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (São Paulo)
• Trial ID: NCT05833997 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and oncological outcomes of Holmium Laser En-bloc Resection of Bladder Tumors (HoLERBT) compared to traditional Transurethral Resection of Bladder Tumors (TURBT) in patients with bladder urothelial carcinoma. It involves a randomized, single-blinded design with 100 participants divided into two groups, each undergoing their respective procedures. The study aims to improve resection quality, reduce complications, and lower recurrence rates by utilizing modern laser technology for tumor removal. Pathological samples will be analyzed to assess the effectiveness of each method.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with bladder tumors larger than 3cm and no signs of muscle-invasive bladder cancer.

Not a fit: Patients with a history of muscle-invasive bladder cancer or those who have had previous bladder surgeries in the last five years may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved surgical outcomes and reduced recurrence rates for patients with bladder cancer.

How similar studies have performed: Other studies have shown promising results with laser techniques in urology, suggesting potential benefits of this approach.

Eligibility criteria

Inclusion Criteria:

* Patients aged between 18 and 80 years old;
* Presence of bladder tumor \> 3cm without signals of MIBC or advanced disease (US, CT scan or MRI 3 months before surgery)
* Able to understand and willing to sign a written informed consent document
* Satisfactory clinical pre operatory conditions for surgery with regional or general anesthesia.

Exclusion Criteria:

* Previous diagnosis of muscle-invasive bladder cancer;
* Tumor's Invasive aspect (T2 or more) on image (US, TC or RNM);
* Previous TURBT in the last 5 years;
* Urethral stenosis;
* Previous intra-vesical os systemic chemotherapy or radiotherapy;
* Previous treatment with intravesical BCG
* No clinical conditions for regional or general anesthesia;
* Any other significant disease or disorder which, in the opinion of the investigator may either put the participant at risk because of trial participation or may influence the trial result, or the participant's ability ti participate in the trial.

Where this trial is running

São Paulo

• Instituto do Cancer do Estado de São Paulo (ICESP) — São Paulo, Brazil (RECRUITING)

Study contacts

• Principal investigator: William Nahas, MD, PhD — Instituto do Cancer do Estado de São Paulo
• Study coordinator: Alexandre Iscaife, MD, PhD

Conditions: Bladder Urothelial Carcinoma, Bladder Cancer, Bladder urothelial cancer, bladder cancer, transurethral resection of bladder tumor, En-bloc Resection of Bladder Tumors