NMIBCNCT06982690
Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial
A study testing Spinal Anesthesia and General Anesthesia in people with NMIBC and TURBT, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
To demonstrate the superior efficacy of spinal anesthesia (SA) versus general anesthesia (GA) according to the delay of time to recurrence in high-risk NMIBC patients up to Week 104 after TURBT. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- NMIBC, TURBT, Bladder (Urothelial, Transitional Cell) Cancer
- What is being tested?
- Spinal Anesthesia and General Anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 370 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Aug 2025to 30 Nov 2029
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥40 years for male subjects or postmenopausal female subjects
- ECOG performance status 0-2
- Patients with suspected or newly diagnosed UBUC
- ASA I or II
- Patients with any other adequately treated Stage I or II cancer except UC, from which the subject has been disease free for 5 years
- Adequate renal function, defined as a serum creatinine (Cre) concentration ≤ the institutional ULN
- Adequate hepatic function, defined as total bilirubin ≤ the institutional ULN and alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ the institutional upper limit of normal (ULN)
Who cannot join
- Patients with prior or concurrent UC involving the renal pelvis, ureter or urethra
- Patients with clinical evidence of MIBC or mUC
- Immunocompromised or immunosuppressed patients
- Patients with chronic use of anti-inflammatory agents or beta-blockers
- Patients with difficult airways or other significant cardiovascular comorbidities (severe aortic stenosis, significant pulmonary disease, CHF) who are intolerant to GA
- Patients with elevated intracranial pressure (ICP), primarily due to intracranial mass and trauma or infection at the site of SA
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- Patients with a serious uncontrolled medical disorder (e.g., trauma, fracture) or active infection that would impair their ability to receive spinal or GA
- Patients with known allergies to propofol, fentanyl, sevoflurane, or bupivacaine
- Subjects with a known history or family history of malignant hyperthermia
- Subjects with bleeding diathesis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Department of Urology, College of Medicine, National Taiwan University
Taipei, Taipei, 100
About this study
Official title: Impact of Anesthesia Modality on Recurrence and Progression in High-Risk Non-Muscle Invasive Bladder Cancer: A Randomized Controlled Trial Comparing Spinal Versus General Anesthesia
To demonstrate the superior efficacy of spinal anesthesia (SA) versus general anesthesia (GA) according to the delay of time to recurrence in high-risk NMIBC patients up to Week 104 after TURBT.
- Conditions
- NMIBC, TURBT, Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer Recurrence, Anesthesia, General, Anesthesia,Spinal
- Being tested
- Spinal Anesthesia, General Anesthesia
- Keywords
- bladder cancer, general anesthesia, spinal anesthesia, recurrence, TURBT
- Medical subject headings
- Non-Muscle Invasive Bladder Neoplasms, Neoplasms, Urinary Bladder Neoplasms, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal AnesthesiaProcedure or surgery
A total of 10-12 mg of 0.5% bupivacaine will be administered into the cerebrospinal fluid of the subarachnoid space using a 25-gauge Quincke spinal needle via an 18-gauge introducer (adjusted by body height). Midazolam (2-5 mg) may be used to decrease anxiety.
General AnesthesiaProcedure or surgery
Induction will be performed with propofol (0.5-1.5 mg/kg) and fentanyl (1-2 µg/kg), and anesthesia will be maintained with sevoflurane (1-3 vol %) via a laryngeal mask or endotracheal intubation. Rocuronium (0.5-0.6 mg/kg) will be used for induction, maintenance and occurrence of obturator jerk.
| Study group | Role | What they receive |
|---|---|---|
| General Anesthesia | Placebo comparator | Not described Receives: Procedure: General Anesthesia |
| Spinal Anesthesia | Active comparator | Not described Receives: Procedure: Spinal Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrence in high risk NMIBC patients
The time to recurrence is defined as the number of days from TURBT to the day on which the subject presents with gross hematuria, positive urine cytology, all-risk bladder tumor relapse or newly diagnosed upper tract UC with pathological confirmation, radiographically detected tumor metastasis, or cancer-specific death beyond 90 days after diagnosis, whichever occurs first.
Measured: From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks
Secondary outcomes (1)
Time to event in high-risk NMIBC patients up to Week 104
An event is defined as a composite variable reflecting the recurrence of a high-risk disease (any high-grade disease, any T1 tumor, multifocal disease, >3 cm, variant histology, lymphovascular invasion, or CIS), disease progression or metastasis, BCG unresponsiveness, or cancer-specific death, whichever occurs first.
Measured: From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Aug 2025 (estimated)
- Primary completion30 Nov 2029 (estimated)
- Study completion30 Nov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NMIBCStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe 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
- Outcomes assessor
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, National Taiwan University Clinical Trial Center, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982690
- Sponsor's protocol ID
- 202411115RINE
- Status last verified
- Apr 2025
- First submitted
- 6 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fang CW, Shau WY, Fan SZ, Chueh JS. Comparison of spinal versus general anaesthesia in high-risk non-muscle invasive bladder cancer: study protocol for a randomised controlled trial. BMJ Open. 2025 Nov 28;15(11):e107824. doi: 10.1136/bmjopen-2025-107824.
PubMed 41314851
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Anesthesia Modality on Recurrence and Progression in High-Risk Non-Muscle Invasive Bladder Cancer: A Randomized Controlled Trial Comparing Spinal Versus General Anesthesia
- ClinicalTrials.gov ID
- NCT06982690
- Acronym / sponsor ID
- 202411115RINE
- Conditions
- NMIBC, TURBT, Bladder (Urothelial, Transitional Cell) Cancer, Bladder Cancer Recurrence, Anesthesia, General, Anesthesia,Spinal
- Keywords
- bladder cancer, general anesthesia, spinal anesthesia, recurrence, TURBT
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 30 Nov 2029 (estimated)
- Study completion
- 30 Nov 2029 (estimated)
- First posted
- 21 May 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.
To demonstrate the superior efficacy of spinal anesthesia (SA) versus general anesthesia (GA) according to the delay of time to recurrence in high-risk NMIBC patients up to Week 104 after TURBT.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anesthesia | Placebo comparator | Procedure: General Anesthesia |
| Spinal Anesthesia | Active comparator | Procedure: Spinal Anesthesia |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥40 years for male subjects or postmenopausal female subjects
- ECOG performance status 0-2
- Patients with suspected or newly diagnosed UBUC
- ASA I or II
- Patients with any other adequately treated Stage I or II cancer except UC, from which the subject has been disease free for 5 years
Key exclusion criteria (10 listed)
- Patients with prior or concurrent UC involving the renal pelvis, ureter or urethra
- Patients with clinical evidence of MIBC or mUC
- Immunocompromised or immunosuppressed patients
- Patients with chronic use of anti-inflammatory agents or beta-blockers
- Patients with difficult airways or other significant cardiovascular comorbidities (severe aortic stenosis, significant pulmonary disease, CHF) who are intolerant to GA
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 |
|---|---|---|
| Spinal AnesthesiaA total of 10-12 mg of 0.5% bupivacaine will be administered into the cerebrospinal fluid of the subarachnoid space using a 25-gauge Quincke spinal needle via an 18-gauge introducer (adjusted by body height). Midazolam (2-5 mg) may be used to decrease anxiety. | Procedure or surgery | Spinal Anesthesia |
| General AnesthesiaInduction will be performed with propofol (0.5-1.5 mg/kg) and fentanyl (1-2 µg/kg), and anesthesia will be maintained with sevoflurane (1-3 vol %) via a laryngeal mask or endotracheal intubation. Rocuronium (0.5-0.6 mg/kg) will be used for induction, maintenance and occurrence of obturator jerk. | Procedure or surgery | General Anesthesia |
Primary outcome
Time to recurrence in high risk NMIBC patients
Time frame: From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks
The time to recurrence is defined as the number of days from TURBT to the day on which the subject presents with gross hematuria, positive urine cytology, all-risk bladder tumor relapse or newly diagnosed upper tract UC with pathological confirmation, radiographically detected tumor metastasis, or cancer-specific death beyond 90 days after diagnosis, whichever occurs first.
1 secondary outcome
Time to event in high-risk NMIBC patients up to Week 104
Time frame: From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks
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 21 May 2025.
- Derived from this study: PubMed 41314851Fang CW, Shau WY, Fan SZ, Chueh JS. Comparison of spinal versus general anaesthesia in high-risk non-muscle invasive bladder cancer: study protocol for a randomised controlled trial. BMJ Open. 2025 Nov 28;15(11):e107824. doi: 10.1136/bmjopen-2025-107824.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal Anesthesia and General Anesthesia in people with NMIBC and TURBT, run by National Taiwan University Hospital at 1 site in Taiwan.
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 7 inclusion and 10 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: opening soon, as of the sponsor's last update on 21 May 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 Taiwan. 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. Some participants in this study may receive a placebo. 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?
Contact Jeff Shih-Chieh Chueh, MD, PhD (+886-2312-3456 ext. 262135, jeffchueh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to recurrence in high risk NMIBC patients (time frame: From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06982690, which also lists 1 linked publication.
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 21 May 2025.