Bipolar Enbloc Versus Thulium-Yag Enbloc Resection of Bladder Tumors (TURBT-Enbloc)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Bladder Cancer
• Intervention / Treatment: Procedure: Bipolar enbloc resection of bladder tumor; Procedure: Thulium laser enbloc resection of bladder tumor

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Menoufia
    • Shibīn Al Kawm, Menoufia, Egypt
      • Menoufia University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2023
• Primary Completion (Estimated): November 10, 2025
• Study Completion (Estimated): December 29, 2025

Study Registration Dates

• First Submitted: June 17, 2023
• First Submitted That Met QC Criteria: November 1, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 29, 2024
• Last Update Submitted That Met QC Criteria: November 26, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Neoplasms; Urinary Bladder Diseases; Urinary Bladder Neoplasms
• Other Study ID Numbers: Bipolar and Thulium-Yag Enbloc

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No