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Trial Title:
Bipolar Enbloc Versus Thulium-Yag Enbloc Resection of Bladder Tumors
NCT ID:
NCT06119724
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Single (Participant)
Intervention:
Intervention type:
Procedure
Intervention name:
Bipolar enbloc resection of bladder tumor
Description:
Enbloc retrival of bladder tumor entoto using cystoscopy using bipolar
Arm group label:
Bipolar enbloc resection of bladder tumors
Intervention type:
Procedure
Intervention name:
Thulium laser enbloc resection of bladder tumor
Description:
Enbloc retrival of bladder tumor entoto using cystoscopy using thulium laser
Arm group label:
Thulium enbloc resection of bladder tumors
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.
Criteria for 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.
Gender:
All
Minimum age:
25 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Menoufia university hospital
Address:
City:
Shibīn Al Kawm
Country:
Egypt
Start date:
June 11, 2023
Completion date:
December 2024
Lead sponsor:
Agency:
Menoufia University
Agency class:
Other
Source:
Menoufia University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06119724
