Clinical trial NCT06119724: Bipolar Enbloc Versus Thulium-Yag Enbloc Resection of Bladder Tumors
Official title: Bipolar Enbloc Versus Thulium-Yag Enbloc Resection Of Bladder Tumors: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Bladder Cancer
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 50
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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.

Primary outcomes:
measure: Enbloc technique effectiveness in obtaining muscle in the speciment
timeFrame: 3 months
measure: Duration of cancer free survival post enbloc resection
timeFrame: 1year
measure: Staging of bladder cancer post enbloc resection
timeFrame: 1year
measure: Presence of residual tumors post resection
timeFrame: 3-6 months
measure: Blood loss
timeFrame: Immediate postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Shibīn Al Kawm
country: Egypt
facility: Menoufia university hospital
state: Menoufia
Study officials:
References: