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

Not Applicable

• Conditions: Bladder Cancer
• Interventions: Procedure: Anesthesia before transurethral resection of the bladder tumor; Drug: Anesthesia

• Registration Number: NCT03597087
• Lead Sponsor: Seoul National University Hospital

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

Study Timeline

• Status Verified: 2018-07
• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-07-13
• Last Update Submitted: 2018-07-13
• Study Start: 2018-07-19
• Study First Posted: 2018-07-24
• Last Update Posted: 2018-07-24
• Primary Completion: 2021-07-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 289

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General anesthesia	Anesthesia	Group of general anesthesia before transurethral resection of the bladder tumor anesthesia: propopol
General anesthesia	Anesthesia before transurethral resection of the bladder tumor	Group of general anesthesia before transurethral resection of the bladder tumor anesthesia: propopol
Spinal anesthesia	Anesthesia before transurethral resection of the bladder tumor	Group of spinal anesthesia before transurethral resection of the bladder tumor anesthesia: bupibacaine
Spinal anesthesia	Anesthesia	Group of spinal anesthesia before transurethral resection of the bladder tumor anesthesia: bupibacaine

Primary Outcome Measures

Name	Time	Method
2-year recurrence-free survival rate	Follow up every 3 months until 2 years after surgery	The criteria for recurrence-free survival and recurrence of bladder cancer for 2 years postoperatively are based on pathological histology. If the recurrence is suspected in the radiological examination but pathological histological examination is difficult, the reference is based on the day of the imaging examination suspected of recurrence.

Secondary Outcome Measures

Name	Time	Method
2-year progression-free survival	Follow up every 3 months until 2 years after surgery	The progression-free survival rate and progression rate of bladder cancer for 2 years postoperatively include both T stage and tumor grade progression.

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of