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
Primary Purpose
Bladder Cancer
Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Anesthesia before transurethral resection of the bladder tumor
Anesthesia
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Cancer focused on measuring Anesthesia, Bladder cancer, Recurrence rate, Transurethral resection of bladder mass
Eligibility Criteria
Inclusion Criteria:
- 18 years old or older
- Patients with suspected Ta / T1 non-muscle invasive bladder cancer
- Patients who were not previously treated with other cancers
- Normal range creatinine, AST, ALT patients
- Patients with both spinal anesthesia and general anesthesia
Exclusion Criteria:
- Patients with urinary tract carcinoma not invading the renal pelvis, ureter or urethra
- Patients with cancer other than bladder cancer or a history of treatment
- Patients with clinical evidence of muscle-invasive bladder cancer
- Patients taking immunosuppressive drugs and immunosuppressive drugs
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
General anesthesia
Spinal anesthesia
Arm Description
Group of general anesthesia before transurethral resection of the bladder tumor anesthesia: propopol
Group of spinal anesthesia before transurethral resection of the bladder tumor anesthesia: bupibacaine
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT03597087
First Posted
July 2, 2018
Last Updated
July 13, 2018
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03597087
Brief 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
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
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 19, 2018 (Anticipated)
Primary Completion Date
July 1, 2021 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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
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.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer
Keywords
Anesthesia, Bladder cancer, Recurrence rate, Transurethral resection of bladder mass
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
None (Open Label)
Masking Description
Using a web site, and creating a randomized list at Sealedenvalop.com. Patients are randomly assigned to receive an anesthetic consent, and no masking is performed.
Allocation
Randomized
Enrollment
289 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
General anesthesia
Arm Type
Experimental
Arm Description
Group of general anesthesia before transurethral resection of the bladder tumor anesthesia: propopol
Arm Title
Spinal anesthesia
Arm Type
Experimental
Arm Description
Group of spinal anesthesia before transurethral resection of the bladder tumor anesthesia: bupibacaine
Intervention Type
Procedure
Intervention Name(s)
Anesthesia before transurethral resection of the bladder tumor
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Anesthesia
Intervention Description
General anaesthesia : propopol
Spinal anaesthesia : bupibacaine
Primary Outcome Measure Information:
Title
2-year recurrence-free survival rate
Description
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.
Time Frame
Follow up every 3 months until 2 years after surgery
Secondary Outcome Measure Information:
Title
2-year progression-free survival
Description
The progression-free survival rate and progression rate of bladder cancer for 2 years postoperatively include both T stage and tumor grade progression.
Time Frame
Follow up every 3 months until 2 years after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
18 years old or older
Patients with suspected Ta / T1 non-muscle invasive bladder cancer
Patients who were not previously treated with other cancers
Normal range creatinine, AST, ALT patients
Patients with both spinal anesthesia and general anesthesia
Exclusion Criteria:
Patients with urinary tract carcinoma not invading the renal pelvis, ureter or urethra
Patients with cancer other than bladder cancer or a history of treatment
Patients with clinical evidence of muscle-invasive bladder cancer
Patients taking immunosuppressive drugs and immunosuppressive drugs
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hyeong Dong Yuk, MD
Phone
+82-2-2072-1968
Email
hinayuk@naver.com
First Name & Middle Initial & Last Name or Official Title & Degree
Song Hee Kim, Bacheolo
Phone
+82-2-2072-1968
Email
songheekim0506@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jin Tae Kim, PhD
Organizational Affiliation
Professor, Department of Anesthesiology, Seoul National University Hospital
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Ja Hyeon Ku, PhD
Organizational Affiliation
Professor, Department of Urology, Seoul National University Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hyeong Dong Yuk, MD
Organizational Affiliation
Clinical fellow, Department of Urology, Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Song Hee Kim, Bacheolor
Organizational Affiliation
Researcher, Department of Urology, Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jae Hyun Jung, MD
Organizational Affiliation
Clinical fellow, Department of Urology, Seoul National University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jung Hoon Lee, MD
Organizational Affiliation
Clinical fellow, Department of Urology, Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
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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
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