Bipolar Enbloc Versus Thulium-Yag Enbloc Resection of Bladder Tumors

Bladder Cancer Clinical Trial

— TURBT-Enbloc  

Official title:

Bipolar Enbloc Versus Thulium-Yag Enbloc Resection Of Bladder Tumors: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06119724
• Other study ID #: Bipolar and Thulium-Yag Enbloc
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 11, 2023
• Est. completion date: December 2024

Study information

• Verified date: November 2023
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prospective controlled study randomized comparing bipolar enbloc versus thulium enbloc for bladder tumours

Description:

Bladder cancer is the ninth most prevalent cancer worldwide and the 2nd most common urologic cancer in the last two decades after cancer prostate . Most bladder cancers attributed to exposure to environmental and occupational chemicals, the largest of which by far is tobacco smoke. Greater tobacco smoke and occupational exposure in men may help in the explanation of the 4-fold gender difference in bladder cancer incidence . Approximately 75-85% of patients with bladder cancer present with disease confined to the mucosa or submucosa , which is referred to as nonmuscle invasive bladder cancer (NMIBC). Transurethral resection of bladder tumor (TURBT) is still considered the gold standard treatment for primary nonmuscle invasive bladder cancer. There are many drawbacks for conventional TURBT procedure such as such as the deficiency of the bladder detrusor muscle In the specimen , the obturator jerk, thermal damage to surrounding tissues, and the technique of( incise and scatter). These drawbacks may lead to difficulty in performing an accurate pathological evaluation of fragment tissue and increase the risk of recurrence. Laser therapy for bladder cancer was first reported in Germany in the 1970s and was approved to clinical use in the USA in 1984. Modern laser technology has led to new alternatives to conventional transurethral resection of bladder tumor (TURBT) due to its efficacy and good control of bleeding. With the introduction of en-bloc resection of urinary bladder tumors, Laser come back into focus. The two most commonly used lasers at present are thulium and holmium Laser. In 2018 PA Geavlete, declared that the enbloc bipolar resection of bladder tumors using mushroom loop provide the advantages of superior surgical safety, decreased perioperative morbidity and faster postoperative recovery, when compared to the standard monopolar TURBT but showed no superiority in oncological outcome.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 50
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 80 Years

Eligibility

• Inclusion criteria:

1. Patients with NMIBC

2. Bladder tumors<4 cm in CT.

3. Resectable bladder tumors.

4. Age <80 years.

• Exclusion criteria :

1. Bladder tumours > 4cm .

2. Metastatic bladder tumors.

3. Patients with carcinoma in situ CIS .

4. Patients with coagulopathies.

5. Domal bladder tumors.

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Bipolar enbloc resection of bladder tumor
Enbloc retrival of bladder tumor entoto using cystoscopy using bipolar
• Thulium laser enbloc resection of bladder tumor
Enbloc retrival of bladder tumor entoto using cystoscopy using thulium laser

Locations

Country	Name	City	State
Egypt	Menoufia university hospital	Shibin Al Kawm	Menoufia

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enbloc technique effectiveness in obtaining muscle in the speciment	Assessed by presence of muscles in histopathological specimen.	3 months
Primary	Duration of cancer free survival post enbloc resection	Duration of Cancer free survival post resection measured by weeks.	1year
Primary	Staging of bladder cancer post enbloc resection	Clinical staging using bimanual examination under anesthesia.	1year
Primary	Presence of residual tumors post resection	Assessed by visualization of any residual mass during second look cystoscopy	3-6 months
Primary	Blood loss	Assessed by comparing between Hemoglobin level pre and post operative	Immediate postoperative