Anesthesia Modality and Oncologic Outcomes in High-Risk NMIBC: A Randomized Trial

Not Applicable

Not yet recruiting

• Conditions: NMIBC; TURBT; Bladder (Urothelial, Transitional Cell) Cancer; Bladder Cancer Recurrence; Anesthesia, General; Anesthesia,Spinal

• Registration Number: NCT06982690
• Lead Sponsor: National Taiwan University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-06
• Study First Submitted QC: 2025-05-13
• Last Update Submitted: 2025-05-13
• Study First Posted: 2025-05-21
• Last Update Posted: 2025-05-21
• Study Start: 2025-08-01
• Primary Completion: 2029-11-30
• Study Completion: 2029-11-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 370

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to recurrence in high risk NMIBC patients	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.

Secondary Outcome Measures

Name	Time	Method
Time to event in high-risk NMIBC patients up to Week 104	From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks	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.

Trial Locations

Locations (1)

Department of Urology, College of Medicine, National Taiwan University; 🇨🇳 Taipei, Taiwan