TURBT-Enbloc: Bipolar Enbloc Versus Thulium-Yag Enbloc Resection of Bladder Tumors

• Sponsor: Menoufia University (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT06119724
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 17.7
• Patients Per Site Per Month: 2.8

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Procedure: Bipolar enbloc resection of bladder tumor; Procedure: Thulium laser enbloc resection of bladder tumor	N/A

Detailed 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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Bipolar Enbloc Versus Thulium-Yag Enbloc Resection Of Bladder Tumors: A Randomized Controlled Trial
• Actual Study Start Date: Jun 11, 2023
• Anticipated Primary Completion Date: Jun 1, 2024
• Anticipated Study Completion Date: Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Bipolar enbloc resection of bladder tumors Patients who have odd number will be in the first group which will be enrolled in bipolar enbloc group	Procedure: Bipolar enbloc resection of bladder tumor; Enbloc retrival of bladder tumor entoto using cystoscopy using bipolar
Active Comparator: Thulium enbloc resection of bladder tumors patients who have even number will be in the second group which will be Thulium-Yag laser enbloc group	Procedure: Thulium laser enbloc resection of bladder tumor; Enbloc retrival of bladder tumor entoto using cystoscopy using thulium laser

Outcome Measures

Primary Outcome Measures

1. Enbloc technique effectiveness in obtaining muscle in the speciment [3 months]

   Assessed by presence of muscles in histopathological specimen.

2. Duration of cancer free survival post enbloc resection [1year]

   Duration of Cancer free survival post resection measured by weeks.

3. Staging of bladder cancer post enbloc resection [1year]

   Clinical staging using bimanual examination under anesthesia.

4. Presence of residual tumors post resection [3-6 months]

   Assessed by visualization of any residual mass during second look cystoscopy

5. Blood loss [Immediate postoperative]

   Assessed by comparing between Hemoglobin level pre and post operative

Eligibility Criteria

Criteria

• Ages Eligible for Study: 25 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

• 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Menoufia university hospital	Shibīn Al Kawm	Menoufia	Egypt

Sponsors and Collaborators

• Menoufia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mohamed Kamal Omar, Associate professor of urology, Menoufia University
• ClinicalTrials.gov Identifier: NCT06119724
• Other Study ID Numbers: Bipolar and Thulium-Yag Enbloc
• First Posted: Nov 7, 2023
• Last Update Posted: Nov 7, 2023
• Last Verified: Nov 1, 2023

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

No Results Posted as of Nov 7, 2023