Clinical trial NCT03597087: The Difference of Two Year Recurrence Rate According to Anesthetic Method During Transurethral Resection of Bladder Mass in Patients With Non-muscle Invasive Bladder Cancer: Prospective, Randomized, Clinical Phase II Study
Official title: The Difference of Two Year Recurrence Rate According to Anesthetic Method During Transurethral Resection of Bladder Mass in Patients With Non-muscle Invasive Bladder Cancer: Prospective, Randomized, Clinical Phase II Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bladder Cancer
Keywords: Anesthesia, Bladder cancer, Recurrence rate, Transurethral resection of bladder mass
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-07-24
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: After randomization, they were divided into two parallel groups 289 patients were randomly assigned to a spinal anesthesia group and a general anesthesia group 1: 1.
Primary purpose: TREATMENT

Brief summary: The investigators compare the recurrence rate difference between two years after transurethral resection of the bladder tumor according to the method of anesthesia. Anesthetic methods are general anesthesia and spinal anesthesia. Assessment of recurrence is assessed by bladder endoscopy, CT, and pathological examination of surgical specimens.

Detailed description: 1. Research Background Most of the bladder cancer (approximately 85%) has histologic features of urothelial carcinoma. Approximately 75% of the patients initially diagnosed as non-invasive bladder cancer (stage I, CIS) or submucosal stage T1 -muscle invasive bladder cancer - NMIBC). However, it has been reported that about 60% to 70% of patients experience recurrence and 20% to 30% of relapsed cancers require radical cystectomy or chemotherapy It is known to progress to high-grade or high grade cancer.

   There are studies that involve surgical factors such as volatile anesthetics, narcotic analgesics, anti-body temperature, blood transfusion, and cancer recurrence. Minimizing the use of volatile anesthetics and narcotic analgesics reduces spinal anesthesia before and after surgery, It has been reported that there is a correlation with maintenance of immune cell function
2. Research hypothesis and purpose The aim of this study was to evaluate the recurrence rate, recurrence - free survival rate, and recurrence - free survival rate of non - muscle invasive bladder carcinoma in patients undergoing bladder resection.
3. Research Method

   * Preoperative screening: Physical examination, Blood test, CT urography, Urine analysis, Urine culture, Urine cytology, Cystoscopy. Enforced
   * Randomization on the day before surgery: 289 patients were randomly assigned to a spinal anesthesia group and a general anesthesia group 1: 1.

Urine analysis, urine culture, urine cytology, and cystoscopy were performed every 3 months up to 2 years postoperatively. CT urography performed once a year

* Follow-up procedure: Follow-up procedure according to bladder cancer standard.

  4. Observation items, clinical examination items and observational examination methods
* Screening: CT urography, Urine analysis, Urine culture, Urine cytology, Cystoscopy. Observe
* Follow up: Urine analysis, Urine culture, Urine cytology, Cystoscopy every 3 months after the operation, CT urography every year

Eligibility criteria: Inclusion Criteria:

1. 18 years old or older
2. Patients with suspected Ta / T1 non-muscle invasive bladder cancer
3. Patients who were not previously treated with other cancers
4. Normal range creatinine, AST, ALT patients
5. Patients with both spinal anesthesia and general anesthesia

Exclusion Criteria:

1. Patients with urinary tract carcinoma not invading the renal pelvis, ureter or urethra
2. Patients with cancer other than bladder cancer or a history of treatment
3. Patients with clinical evidence of muscle-invasive bladder cancer
4. Patients taking immunosuppressive drugs and immunosuppressive drugs

Primary outcomes:
measure: 2-year recurrence-free survival rate
timeFrame: Follow up every 3 months until 2 years after surgery
Secondary outcomes:
measure: 2-year progression-free survival
timeFrame: Follow up every 3 months until 2 years after surgery
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Professor, Department of Anesthesiology, Seoul National University Hospital
name: Jin Tae Kim, PhD
role: STUDY_DIRECTOR
affiliation: Professor, Department of Urology, Seoul National University Hospital
name: Ja Hyeon Ku, PhD
role: STUDY_CHAIR
affiliation: Clinical fellow, Department of Urology, Seoul National University Hospital
name: Hyeong Dong Yuk, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Researcher, Department of Urology, Seoul National University Hospital
name: Song Hee Kim, Bacheolor
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical fellow, Department of Urology, Seoul National University Hospital
name: Jae Hyun Jung, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical fellow, Department of Urology, Seoul National University Hospital
name: Jung Hoon Lee, MD
role: PRINCIPAL_INVESTIGATOR
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