Bladder CancerTURBT-EnblocNCT06119724
Bipolar Enbloc Versus Thulium-Yag Enbloc Resection of Bladder Tumors
A study testing Bipolar enbloc resection of bladder tumor and Thulium laser enbloc resection of bladder tumor in people with Bladder Cancer, run by Menoufia University at 1 site in Egypt.
Trial summary
Prospective controlled study randomized comparing bipolar enbloc versus thulium enbloc for bladder tumours Read more about this study
- Who is it for?
- Ages 25 to 80 years
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Bipolar enbloc resection of bladder tumor and Thulium laser enbloc resection of bladder tumor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Jun 2023to 29 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with NMIBC
- Bladder tumors<4 cm in CT.
- Resectable bladder tumors.
- Age <80 years.
Who cannot join
- Bladder tumours > 4cm .
- Metastatic bladder tumors.
- Patients with carcinoma in situ CIS .
- Patients with coagulopathies.
- Domal bladder tumors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Conditions
- Bladder Cancer
- Being tested
- Bipolar enbloc resection of bladder tumor, Thulium laser enbloc resection of bladder tumor
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar enbloc resection of bladder tumorProcedure or surgery
Enbloc retrival of bladder tumor entoto using cystoscopy using bipolar
Thulium laser enbloc resection of bladder tumorProcedure or surgery
Enbloc retrival of bladder tumor entoto using cystoscopy using thulium laser
| Study group | Role | What they receive |
|---|---|---|
| Bipolar enbloc resection of bladder tumors | Active comparator | Patients who have odd number will be in the first group which will be enrolled in bipolar enbloc group Receives: Procedure: Bipolar enbloc resection of bladder tumor |
| Thulium enbloc resection of bladder tumors | Active comparator | patients who have even number will be in the second group which will be Thulium-Yag laser enbloc group Receives: Procedure: Thulium laser enbloc resection of bladder tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enbloc technique effectiveness in obtaining muscle in the speciment
Assessed by presence of muscles in histopathological specimen.
Measured: 3 months
Duration of cancer free survival post enbloc resection
Duration of Cancer free survival post resection measured by weeks.
Measured: 1year
Staging of bladder cancer post enbloc resection
Clinical staging using bimanual examination under anesthesia.
Measured: 1year
Presence of residual tumors post resection
Assessed by visualization of any residual mass during second look cystoscopy
Measured: 3-6 months
Blood loss
Assessed by comparing between Hemoglobin level pre and post operative
Measured: Immediate postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start11 Jun 2023
- Primary completion10 Nov 2025 (estimated)
- Study completion29 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Menoufia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Kamal Omar, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119724
- Sponsor's protocol ID
- Bipolar and Thulium-Yag Enbloc
- Acronym
- TURBT-Enbloc
- Status last verified
- Nov 2024
- First submitted
- 17 Jun 2023
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Enbloc Versus Thulium-Yag Enbloc Resection Of Bladder Tumors: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06119724
- Acronym / sponsor ID
- TURBT-Enbloc / Bipolar and Thulium-Yag Enbloc
- Conditions
- Bladder Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 11 Jun 2023 (actual)
- Primary completion
- 10 Nov 2025 (estimated)
- Study completion
- 29 Dec 2025 (estimated)
- First posted
- 7 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar enbloc resection of bladder tumors | Active comparator | Procedure: Bipolar enbloc resection of bladder tumorPatients who have odd number will be in the first group which will be enrolled in bipolar enbloc group |
| Thulium enbloc resection of bladder tumors | Active comparator | Procedure: Thulium laser enbloc resection of bladder tumorpatients who have even number will be in the second group which will be Thulium-Yag laser enbloc group |
Who may qualify
- Ages
- 25 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bipolar enbloc resection of bladder tumorEnbloc retrival of bladder tumor entoto using cystoscopy using bipolar | Procedure or surgery | Bipolar enbloc resection of bladder tumors |
| Thulium laser enbloc resection of bladder tumorEnbloc retrival of bladder tumor entoto using cystoscopy using thulium laser | Procedure or surgery | Thulium enbloc resection of bladder tumors |
Primary outcome
Enbloc technique effectiveness in obtaining muscle in the speciment
Time frame: 3 months
Assessed by presence of muscles in histopathological specimen.
Duration of cancer free survival post enbloc resection
Time frame: 1year
Duration of Cancer free survival post resection measured by weeks.
Staging of bladder cancer post enbloc resection
Time frame: 1year
Clinical staging using bimanual examination under anesthesia.
Presence of residual tumors post resection
Time frame: 3-6 months
Assessed by visualization of any residual mass during second look cystoscopy
Blood loss
Time frame: Immediate postoperative
Assessed by comparing between Hemoglobin level pre and post operative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Individual participant dataSharing planned: Undecided. Yes
Related trials for Bladder Cancer
RecruitingPhase 2
Testing the Addition of the Immunotherapy Drug, Pembrolizumab, to Radiation Therapy Compared to the Usual Chemotherapy Treatment During Radiation Therapy for Bladder Cancer, PARRC Trial
Non-Muscle Invasive Bladder Urothelial Carcinoma, Recurrent Non-Muscle Invasive Bladder Urothelial Carcinoma
Not yet recruiting
Diagnostic Performance of Multiparametric Magnetic Resonance Imaging After Transurethral Resection of Bladder Tumour for Prediction of Muscle Invasion and Detection of Residual Tumour in Non-muscle-invasive Bladder Cancer Patients
Urinary Bladder Cancer, NMIBC
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
RecruitingObservational study
Collection of Serum and Tissue Samples From Patients With Biopsy-Proved or Suspected Malignant Disease
Malignant Neoplasms, Hereditary Neoplastic Syndromes
Recruiting
Evaluation of the Clinical Utility of Online Adaptive Radiotherapy in Bladder Cancer (BLADAPT-GETUG V11)
Bladder Cancer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar enbloc resection of bladder tumor and Thulium laser enbloc resection of bladder tumor in people with Bladder Cancer, run by Menoufia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enbloc technique effectiveness in obtaining muscle in the speciment (time frame: 3 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.