Bladder CancerNCT06796413
Loop Resection or Cold-cup Biopsy? A Study Comparing the Accuracy of Muscle Samples During Bladder Tumor Surgery
A study testing Loop Resection or Cold-cup biopsy in people with Bladder Cancer and Bladder Cancer Stage I, run by University of Stellenbosch at 1 site in South Africa.
Trial summary
In this report the investigators compared two deep muscle sampling methods (Loop resection and Cold-Cup Biopsy) during endoscopic resection of bladder tumors for patients with suspected bladder cancer in Tygerberg hospital. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bladder Cancer, Bladder Cancer Stage I, TURBT
- What is being tested?
- Loop Resection or Cold-cup biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSouth Africa
- Study dates
- 14 Jul 2022to 1 Jul 2024
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • All patients requiring cystoscopy plus loop resection of bladder tumor.
Who cannot join
- • Patients who underwent cystoscopy and no loop resection
- Patients who underwent cystoscopy and only cold-cup biopsy
Trial locations and contacts
1 site in 1 country.
South Africa1 site
Stellenbosch University - Faculty of Health Sciences - Department of Urology
Cape Town, Western Cape, 7500
About this study
Official title: Loop Resection or Cold-cup Biopsy? A Prospective Randomized Study Evaluating the Accuracy of Detrusor Muscle Representation During Transurethral Resection of Bladder Tumors
In this report the investigators compared two deep muscle sampling methods (Loop resection and Cold-Cup Biopsy) during endoscopic resection of bladder tumors for patients with suspected bladder cancer in Tygerberg hospital. The investigators found that both sampling methods are equal effective with regards to muscle representation, regardless of surgeon experience. An important finding is that Loop Resection produced less tissue artefacts in the deep muscle specimen for the more experienced surgeons, while there was no difference for less experienced surgeons. The investigators thus conclude that - from a practical point of view - Loop Resection should be the deep muscle sampling method of choice.
- Conditions
- Bladder Cancer, Bladder Cancer Stage I, TURBT
- Being tested
- Loop Resection or Cold-cup biopsy
- Keywords
- Bladder Cancer, Detrusor Muscle Sampling, Detrusor Muscle Representation, Loop Resection, Cold-Cup Biopsy, Artifacts
- 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.
Loop Resection or Cold-cup biopsyProcedure or surgery
Also called Loop Cautery, Cold-cup Biopsy
Loop Resection or cold-cup biopsy of bladder tumor base - thus after the tumor has been resected and the deep muscle specimen needed to be obtained, the Loop Cautery or Lowsley Forceps (for cold-cup biopsy) was used to obtain the deep muscle specimen
| Study group | Role | What they receive |
|---|---|---|
| Cold-Cup Biopsy | Active comparator | Cold-Cup Biopsy of bladder tumor base Receives: Procedure: Loop Resection or Cold-cup biopsy |
| Loop Resection of bladder tumor base | Experimental | Loop Resection of bladder tumor base Receives: Procedure: Loop Resection or Cold-cup biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detrusor Muscle Representation
Histopathological confirmation of detrusor muscle representation in the Deep Muscle Specimen obtained by either the Loop Resection method or Cold-Cup Biopsy method
Measured: From enrollment to the end of treatment at 2-4 weeks when histology results are available
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start14 Jul 2022
- Primary completion23 May 2024
- Study completion1 Jul 2024
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.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Stellenbosch
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Eduan Delport, University of Stellenbosch
- Investigators
- Eduan Delport, MB, ChB, Principal investigator, University of Stellenbosch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796413
- Sponsor's protocol ID
- 17234
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Some of the personal detail of the participants may have changed or may not be so easily attainable.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Loop Resection or Cold-cup Biopsy? A Prospective Randomized Study Evaluating the Accuracy of Detrusor Muscle Representation During Transurethral Resection of Bladder Tumors
- ClinicalTrials.gov ID
- NCT06796413
- Acronym / sponsor ID
- 17234
- Conditions
- Bladder Cancer, Bladder Cancer Stage I, TURBT
- Keywords
- Bladder Cancer, Detrusor Muscle Sampling, Detrusor Muscle Representation, Loop Resection, Cold-Cup Biopsy, Artifacts
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of StellenboschUniversity, hospital or other
- Study start
- 14 Jul 2022 (actual)
- Primary completion
- 23 May 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 28 Jan 2025 (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.
In this report the investigators compared two deep muscle sampling methods (Loop resection and Cold-Cup Biopsy) during endoscopic resection of bladder tumors for patients with suspected bladder cancer in Tygerberg hospital. The investigators found that both sampling methods are equal effective with regards to muscle representation, regardless of surgeon experience. An important finding is that Loop Resection produced less tissue artefacts in the deep muscle specimen for the more experienced surgeons, while there was no difference for less experienced surgeons. The investigators thus conclude that - from a practical point of view - Loop Resection should be the deep muscle sampling method of choice.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cold-Cup Biopsy | Active comparator | Procedure: Loop Resection or Cold-cup biopsyCold-Cup Biopsy of bladder tumor base |
| Loop Resection of bladder tumor base | Experimental | Procedure: Loop Resection or Cold-cup biopsyLoop Resection of bladder tumor base |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- • All patients requiring cystoscopy plus loop resection of bladder tumor.
Key exclusion criteria (2 listed)
- • Patients who underwent cystoscopy and no loop resection
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 |
|---|---|---|
| Loop Resection or Cold-cup biopsyAlso: Loop Cautery, Cold-cup BiopsyLoop Resection or cold-cup biopsy of bladder tumor base - thus after the tumor has been resected and the deep muscle specimen needed to be obtained, the Loop Cautery or Lowsley Forceps (for cold-cup biopsy) was used to obtain the deep muscle specimen | Procedure or surgery | Cold-Cup Biopsy, Loop Resection of bladder tumor base |
Primary outcome
Detrusor Muscle Representation
Time frame: From enrollment to the end of treatment at 2-4 weeks when histology results are available
Histopathological confirmation of detrusor muscle representation in the Deep Muscle Specimen obtained by either the Loop Resection method or Cold-Cup Biopsy method
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: Undecided. Some of the personal detail of the participants may have changed or may not be so easily attainable.
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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.
Eduan Delport, MB, ChB principal investigator
University of Stellenbosch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loop Resection or Cold-cup biopsy in people with Bladder Cancer and Bladder Cancer Stage I, run by University of Stellenbosch at 1 site in South Africa.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 28 Jan 2025. 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 South Africa. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Detrusor Muscle Representation (time frame: From enrollment to the end of treatment at 2-4 weeks when histology results are available). 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 28 Jan 2025.