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

Seoul National University

Status: Unknown

Conditions: Bladder Cancer

Treatments: Drug: Anesthesia; Procedure: Anesthesia before transurethral resection of the bladder tumor

Study type: Interventional

Funder types: Other

Identifiers

NCT03597087

SeoulNUH_2018_TURBT

Details and patient eligibility

About

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.

Full 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

Enrollment: 289 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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289 participants in 2 patient groups

General anesthesia

Experimental group

Description:

Group of general anesthesia before transurethral resection of the bladder tumor anesthesia: propopol

Treatment:

Procedure: Anesthesia before transurethral resection of the bladder tumor

Drug: Anesthesia

Spinal anesthesia

Experimental group

Description:

Group of spinal anesthesia before transurethral resection of the bladder tumor anesthesia: bupibacaine

Treatment:

Procedure: Anesthesia before transurethral resection of the bladder tumor

Drug: Anesthesia