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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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ClinicalTrials.gov Identifier: NCT03597087
Recruitment Status : Not yet recruiting
First Posted : July 24, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Ja Hyeon Ku, 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.

Condition or disease Intervention/treatment Phase
Bladder Cancer Procedure: Anesthesia before transurethral resection of the bladder tumor Drug: Anesthesia Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 289 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
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.
Primary Purpose: Treatment
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
Estimated Study Start Date : July 19, 2018
Estimated Primary Completion Date : July 1, 2021
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

Arm Intervention/treatment
Experimental: General anesthesia
Group of general anesthesia before transurethral resection of the bladder tumor anesthesia: propopol
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


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





Primary Outcome Measures :
  1. 2-year recurrence-free survival rate [ Time Frame: 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 :
  1. 2-year progression-free survival [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03597087


Contacts
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Contact: Hyeong Dong Yuk, MD +82-2-2072-1968 hinayuk@naver.com
Contact: Song Hee Kim, Bacheolo +82-2-2072-1968 songheekim0506@gmail.com

Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Jin Tae Kim, PhD Professor, Department of Anesthesiology, Seoul National University Hospital
Study Chair: Ja Hyeon Ku, PhD Professor, Department of Urology, Seoul National University Hospital
Principal Investigator: Hyeong Dong Yuk, MD Clinical fellow, Department of Urology, Seoul National University Hospital
Principal Investigator: Song Hee Kim, Bacheolor Researcher, Department of Urology, Seoul National University Hospital
Principal Investigator: Jae Hyun Jung, MD Clinical fellow, Department of Urology, Seoul National University Hospital
Principal Investigator: Jung Hoon Lee, MD Clinical fellow, Department of Urology, Seoul National University Hospital

Publications of Results:

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Responsible Party: Ja Hyeon Ku, Professor, MD., PHD., Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03597087     History of Changes
Other Study ID Numbers: SeoulNUH_2018_TURBT
First Posted: July 24, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ja Hyeon Ku, Seoul National University Hospital:
Anesthesia, Bladder cancer, Recurrence rate, Transurethral resection of bladder mass

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Recurrence
Urologic Diseases
Disease Attributes
Pathologic Processes
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs