Bladder NeoplasmPhase 2NCT04784507
En-Bloc Resection of Bladder Tumors
A Phase 2 study testing En Bloc Resection and Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar) in people with Bladder Neoplasm, run by Betul Kartal at 2 sites in Turkey (Türkiye).
Trial summary
Observational data shows that "en bloc" resection of bladder tumor (EBR-BT) may entail advantages when compared with conventional transurethral bladder tumor resection (TURBT). EBR-BT has the potential to increase the rate of correct staging and accurate assignment of risk-classification in non-muscle-invasive bladder… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Neoplasm
- What is being tested?
- En Bloc Resection and Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 1 Apr 2020to 30 Jul 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18 years old and older (adult, older adult) Sexes: All Accepts healthy volunteers: No
- Patients aged 18 and older presenting with suspicion of primary or recurrent Non-muscle invasive bladder cancer (NMIBC)
- Tumor size estimated by cystoscopy ≤ 3 cm
- Solitary or multiple tumors (up to 3 in number)
Who cannot join
- Tumor size > 3 cm of maximum dimeter
- Patient with severe systemic disease (ASA III+)
- Location on the anterior bladder wall and/ or anterior bladder neck (relative contraindication depending on accessibility)
- Pregnancy
- Histological diagnosis other than NMIBC urothelial bladder cancer
- Presence or history of previous upper-tract urinary cancer (UTUC)
Show all 12Show fewer
- Presence of positive cytology without macroscopic identifiable bladder tumor
- Life expectancy < 1 year
- Non-reversible coagulopathy
- Bladder tumor detected during intravesical BCG therapy
- Tumor multiplicity (> 3 tumors)
- Contacts and locations:
Trial locations and contacts
2 sites in 1 country.
Betul Kartal contact
Turkey (Türkiye)2 sites, 2 recruiting
- Recruiting
Bagcilar Education and Research Hospital
Istanbul, Bagcilar, 34200
Bagcilar, (0212) 440 40 00
- Recruiting
Medipol Mega University Hospital
Istanbul, Bagcilar, 34214
Medipol, 444 7 044
About this study
Official title: En-Bloc Resection of Bladder Tumors: a Multicentric Safety and Feasibility Trial (IDEAL Phase II) vs Conventional Resection of Bladder Tumors?
Observational data shows that "en bloc" resection of bladder tumor (EBR-BT) may entail advantages when compared with conventional transurethral bladder tumor resection (TURBT). EBR-BT has the potential to increase the rate of correct staging and accurate assignment of risk-classification in non-muscle-invasive bladder cancer (NMIBC) and to avoid re-TURBT in a considerable number of high-grade NMIBC by demonstrating total macro and microscopic eradication of the primary tumor and to provide the basis for a correct treatment based on a correct stage.
Following the rules of the IDEAL collaboration evaluation and stages of surgical innovation and considering EBR-BT as a surgical technical innovation, the investigators designed a multi-institutional, stage 2a/b study on feasibility (procedural success), safety (including pathology features), and short-term efficacy of EBR-BT and as proof of concept on the reliability of NMIBC staging.
Read more
Main objective: to prospectively assess the pathological efficacy of EBR-BT in the staging of bladder cancer and the clinical efficacy at short-term recurrence-free survival.
Secondary objectives: To assess the clinical efficacy at short-term (3-months) of EBR-BT, and to compare efficacy in the staging of the EBR-BT with the conventional TURBT.
Read the detailed description
En-bloc resection of bladder tumors (EBR-BT) has been showing certain advantages over conventional transurethral resection technique (TURBT) in non-muscle-invasive bladder cancer. These advantages consist mainly in the reduction of obturator nerve reflex and obtention of surgical samples according to oncological principles. Advantages in terms of tumor recurrence in the short-term, when compared with TURBT, remain uncertain. Herein several randomized control trials aim to assess comparative outcomes in the short and long term.
A higher rate of detrusor muscle is found in the EBR-BT samples than in the conventional samples resulting in a better staging and at least theoretically the need for fewer re-TURBT indications. However, a detailed and scrupulous description of the histopathological samples is lacking and, it is assumed that the presence of detrusor in the sample without solution of continuity with submucosa and tumor is sufficient to stage. As in surgical samples of other organs, the objective of EBR-RT is not only to obtain detrusor, but also clean margins that ensure the radicality of the tumor.
The hypothesis of the investigators' is that EBR-BT will results in an increased rate of pathological specimen with the presence of detrusor muscle and free-tumor margins, hence a more accurate stage than TURBT and a decrease in 3-months recurrence at short-term (3 months)
- Conditions
- Bladder Neoplasm
- Being tested
- En Bloc Resection, Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)
- Keywords
- Urinary Bladder Neoplasms, Urologic Neoplasms, Urogenital Neoplasms
- Medical subject headings
- Urinary Bladder Neoplasms, Urologic Neoplasms, Urogenital Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
En Bloc ResectionProcedure or surgery
En bloc transurethral resection of bladder tumor (EBR-BT) using any energy source (laser and bipolar or monopolar energy)
Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)Procedure or surgery
Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)
| Study group | Role | What they receive |
|---|---|---|
| En Bloc Resection Bladder Tumor (Any energy source) | Experimental | Patients with suspicion of NMIBC (primary or recurrent) that underwent en bloc resection (EBRT Receives: Procedure: En Bloc Resection |
| Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar) | Active comparator | Patients with suspicion of NMIBC (primary or recurrent) that underwent conventional TURBT Receives: Procedure: Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological Staging
Staging of NMIBC is defined by the presence of sufficient detrusor in the EBR-BT specimens, the status of the margins, presence of a tumor and /or CIS in the mucosal margins, the status of the detrusor margin, and suspicion of instability in mucosa free of tumor.
Measured: Immediately after the intervention
Recurrence at 3 months
Recurrence free survival at 3-months (absence of visible tumors at the site of the previous resection
Measured: 3 months
Secondary outcomes (2)
Operative Complications
Rate of operative complications (estimated bleeding, bladder perforation, obturatory reflex, tumor fragmentation, conversion to conventional TURBT)
Measured: intraoperative
Perioperative Complications
Postoperative complications according to Clavien-Dindo classification
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2021
- Study start1 Apr 2020
- Primary completion31 May 2022 (estimated)
- Study completion30 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder NeoplasmStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Betul Kartal
- Sponsor type
- University, hospital or other
- Collaborators
- Bağcılar Eğitim ve Araştırma Hastanesi
- Responsible party
- Sponsor-investigator, Betul Kartal, Medipol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04784507
- Sponsor's protocol ID
- 10840098-604.01.01-E.55105
- Status last verified
- Apr 2022
- First submitted
- 26 Feb 2021
- Last updated
- 12 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data will be provided by request according to the primary objectives of the IPD study and according to the availability in the present trial
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- En-Bloc Resection of Bladder Tumors: a Multicentric Safety and Feasibility Trial (IDEAL Phase II) vs Conventional Resection of Bladder Tumors?
- ClinicalTrials.gov ID
- NCT04784507
- Acronym / sponsor ID
- 10840098-604.01.01-E.55105
- Conditions
- Bladder Neoplasm
- Keywords
- Urinary Bladder Neoplasms, Urologic Neoplasms, Urogenital Neoplasms
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Betul KartalUniversity, hospital or other
- Collaborators
- Bağcılar Eğitim ve Araştırma Hastanesi
- Study start
- 1 Apr 2020 (actual)
- Primary completion
- 31 May 2022 (estimated)
- Study completion
- 30 Jul 2022 (estimated)
- First posted
- 5 Mar 2021 (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.
Observational data shows that "en bloc" resection of bladder tumor (EBR-BT) may entail advantages when compared with conventional transurethral bladder tumor resection (TURBT). EBR-BT has the potential to increase the rate of correct staging and accurate assignment of risk-classification in non-muscle-invasive bladder cancer (NMIBC) and to avoid re-TURBT in a considerable number of high-grade NMIBC by demonstrating total macro and microscopic eradication of the primary tumor and to provide the basis for a correct treatment based on a correct stage.
Following the rules of the IDEAL collaboration evaluation and stages of surgical innovation and considering EBR-BT as a surgical technical innovation, the investigators designed a multi-institutional, stage 2a/b study on feasibility (procedural success), safety (including pathology features), and short-term efficacy of EBR-BT and as proof of concept on the reliability of NMIBC staging.
Main objective: to prospectively assess the pathological efficacy of EBR-BT in the staging of bladder cancer and the clinical efficacy at short-term recurrence-free survival.
Secondary objectives: To assess the clinical efficacy at short-term (3-months) of EBR-BT, and to compare efficacy in the staging of the EBR-BT with the conventional TURBT.
Detailed description
En-bloc resection of bladder tumors (EBR-BT) has been showing certain advantages over conventional transurethral resection technique (TURBT) in non-muscle-invasive bladder cancer. These advantages consist mainly in the reduction of obturator nerve reflex and obtention of surgical samples according to oncological principles. Advantages in terms of tumor recurrence in the short-term, when compared with TURBT, remain uncertain. Herein several randomized control trials aim to assess comparative outcomes in the short and long term.
A higher rate of detrusor muscle is found in the EBR-BT samples than in the conventional samples resulting in a better staging and at least theoretically the need for fewer re-TURBT indications. However, a detailed and scrupulous description of the histopathological samples is lacking and, it is assumed that the presence of detrusor in the sample without solution of continuity with submucosa and tumor is sufficient to stage. As in surgical samples of other organs, the objective of EBR-RT is not only to obtain detrusor, but also clean margins that ensure the radicality of the tumor.
The hypothesis of the investigators' is that EBR-BT will results in an increased rate of pathological specimen with the presence of detrusor muscle and free-tumor margins, hence a more accurate stage than TURBT and a decrease in 3-months recurrence at short-term (3 months)
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| En Bloc Resection Bladder Tumor (Any energy source) | Experimental | Procedure: En Bloc ResectionPatients with suspicion of NMIBC (primary or recurrent) that underwent en bloc resection (EBRT |
| Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar) | Active comparator | Procedure: Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)Patients with suspicion of NMIBC (primary or recurrent) that underwent conventional TURBT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age: 18 years old and older (adult, older adult) Sexes: All Accepts healthy volunteers: No
- Patients aged 18 and older presenting with suspicion of primary or recurrent Non-muscle invasive bladder cancer (NMIBC)
- Tumor size estimated by cystoscopy ≤ 3 cm
- Solitary or multiple tumors (up to 3 in number)
Key exclusion criteria (12 listed)
- Tumor size > 3 cm of maximum dimeter
- Patient with severe systemic disease (ASA III+)
- Location on the anterior bladder wall and/ or anterior bladder neck (relative contraindication depending on accessibility)
- Pregnancy
- Histological diagnosis other than NMIBC urothelial bladder cancer
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 |
|---|---|---|
| En Bloc ResectionEn bloc transurethral resection of bladder tumor (EBR-BT) using any energy source (laser and bipolar or monopolar energy) | Procedure or surgery | En Bloc Resection Bladder Tumor (Any energy source) |
| Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar)Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar) | Procedure or surgery | Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar) |
Primary outcome
Pathological Staging
Time frame: Immediately after the intervention
Staging of NMIBC is defined by the presence of sufficient detrusor in the EBR-BT specimens, the status of the margins, presence of a tumor and /or CIS in the mucosal margins, the status of the detrusor margin, and suspicion of instability in mucosa free of tumor.
Recurrence at 3 months
Time frame: 3 months
Recurrence free survival at 3-months (absence of visible tumors at the site of the previous resection
2 secondary outcomes
Operative Complications
Time frame: intraoperative
Perioperative Complications
Time frame: Up to 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2022.
- Individual participant dataSharing planned: Undecided. Data will be provided by request according to the primary objectives of the IPD study and according to the availability in the present trial
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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.
Betul Kartal contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing En Bloc Resection and Conventional Transurethral Resection Bladder Tumor (Mono/Bipolar) in people with Bladder Neoplasm, run by Betul Kartal at 2 sites in Turkey (Türkiye).
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 12 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: status not confirmed, as of the sponsor's last update on 12 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Turkey (Türkiye). 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rahim Horuz (+90533 934 38 50, rhoruz@medipol.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological Staging (time frame: Immediately after the intervention). The study lists 2 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 12 Apr 2022.