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

ConditionsNMIBCTURBTBladder (Urothelial, Transitional Cell) CancerBladder Cancer RecurrenceAnesthesia, GeneralAnesthesia,Spinal
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-80
SponsorNational Taiwan University Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Spinal Anesthesia

    Procedure/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 Anesthesia

    Procedure/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.

Treatment groups

370 Participants
are divided into 2 treatment groups
Group A: General AnesthesiaPlacebo comparator 1 intervention
Group B: Spinal AnesthesiaActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
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.

Time frame
From date of TURBT (Study Day 0) until documented recurrence or last follow-up, up to 104 weeks

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Department of Urology, College of Medicine, National Taiwan University Status unavailable 100, Taipei, TaipeiTaiwanTaiwan

Sponsors and contacts

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National Taiwan University Hospital

Lead sponsor

Source ClinicalTrials.gov

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