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

Bladder Cancer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03597087
• Other study ID #: SeoulNUH_2018_TURBT
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 19, 2018
• Est. completion date: December 31, 2022

Study information

• Verified date: July 2018
• Source: Seoul National University Hospital
• Contact: Hyeong Dong Yuk, MD
• Phone: +82-2-2072-1968
• Email: hinayuk[@]naver.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 289
• Est. completion date: December 31, 2022
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Recurrence
• Urinary Bladder Neoplasms

Intervention

Procedure:
• Anesthesia before transurethral resection of the bladder tumor
General anaesthesia or general anesthesia (see spelling differences) is a medically induced coma with loss of protective reflexes, resulting from the administration of one or more general anaesthetic agents. Spinal anaesthesia is a form of regional anaesthesia involving the injection of a local anaesthetic into the subarachnoid space, generally through a fine needle

Drug:
• Anesthesia
General anaesthesia : propopol Spinal anaesthesia : bupibacaine

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (23)

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* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	2-year recurrence-free survival rate	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.	Follow up every 3 months until 2 years after surgery
Secondary	2-year progression-free survival	The progression-free survival rate and progression rate of bladder cancer for 2 years postoperatively include both T stage and tumor grade progression.	Follow up every 3 months until 2 years after surgery