Clinical trial · Interventional
Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial
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
NCT06982690CI-TRIAL-00089994not yet recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Anesthesia, General | — | UNRESOLVED | — |
| Anesthesia,Spinal | — | UNRESOLVED | — |
| Bladder Cancer Recurrence | — | UNRESOLVED | — |
| Bladder (Urothelial, Transitional Cell) Cancer | — | UNRESOLVED | — |
| NMIBC | Non-Muscle Invasive Bladder Carcinoma | ALIAS | 0.90 |
| TURBT | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| General Anesthesia | Procedure | — | UNRESOLVED |
| Spinal Anesthesia | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- PLACEBO_COMPARATOR
- label
- General Anesthesia
- interventionNames
- Procedure: General Anesthesia
- type
- ACTIVE_COMPARATOR
- label
- Spinal Anesthesia
- interventionNames
- Procedure: Spinal Anesthesia
Primary outcomes (1)
- measure
- Time to recurrence in high risk NMIBC patients
- timeFrame
- From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * 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) Exclusion Criteria: * 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 * 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
References
Publications (1)
- DERIVEDFang 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. PMID 41314851