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

Menoufia University

Status: Active, not recruiting

Conditions: Bladder Cancer

Treatments: Procedure: Bipolar enbloc resection of bladder tumor; Procedure: Thulium laser enbloc resection of bladder tumor

Study type: Interventional

Funder types: Other

Identifiers

NCT06119724

Bipolar and Thulium-Yag Enbloc

Details and patient eligibility

About

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

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 25 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Bipolar enbloc resection of bladder tumors

Active Comparator group

Description:

Patients who have odd number will be in the first group which will be enrolled in bipolar enbloc group

Treatment:

Procedure: Bipolar enbloc resection of bladder tumor

Thulium enbloc resection of bladder tumors

Active Comparator group

Description:

patients who have even number will be in the second group which will be Thulium-Yag laser enbloc group

Treatment:

Procedure: Thulium laser enbloc resection of bladder tumor