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

July 13, 2018 updated by: Ja Hyeon Ku, Seoul National University Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

289

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Follow up every 3 months until 2 years after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Follow up every 3 months until 2 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

July 19, 2018

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

December 31, 2022

Study Registration Dates

First Submitted

July 2, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (Actual)

July 24, 2018

Study Record Updates

Last Update Posted (Actual)

July 24, 2018

Last Update Submitted That Met QC Criteria

July 13, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SeoulNUH_2018_TURBT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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