Bladder CancerNCT03597087
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
A study testing Anesthesia before transurethral resection of the bladder tumor and Anesthesia in people with Bladder Cancer, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Anesthesia before transurethral resection of the bladder tumor and Anesthesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 289 participants
- Where
- 1 siteSouth Korea
- Study dates
- 19 Jul 2018to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- 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
- Conditions
- Bladder Cancer
- Being tested
- Anesthesia before transurethral resection of the bladder tumor, Anesthesia
- Keywords
- Anesthesia, Bladder cancer, Recurrence rate, Transurethral resection of bladder mass
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anesthesia before transurethral resection of the bladder tumorProcedure or surgery
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
AnesthesiaDrug
General anaesthesia : propopol
Spinal anaesthesia : bupibacaine
| Study group | Role | What they receive |
|---|---|---|
| General anesthesia | Experimental | Group of general anesthesia before transurethral resection of the bladder tumor anesthesia: propopol Receives: Procedure: Anesthesia before transurethral resection of the bladder tumor; Drug: Anesthesia |
| Spinal anesthesia | Experimental | Group of spinal anesthesia before transurethral resection of the bladder tumor anesthesia: bupibacaine Receives: Procedure: Anesthesia before transurethral resection of the bladder tumor; Drug: Anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Follow up every 3 months until 2 years after surgery
Secondary outcomes (1)
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.
Measured: Follow up every 3 months until 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start19 Jul 2018 (estimated)
- Primary completion1 Jul 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (24)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 289 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ja Hyeon Ku, Seoul National University Hospital
- Investigators
- Jin Tae Kim, PhD, Study director, Professor, Department of Anesthesiology, Seoul National University HospitalJa Hyeon Ku, PhD, Study chair, Professor, Department of Urology, Seoul National University HospitalHyeong Dong Yuk, MD, Principal investigator, Clinical fellow, Department of Urology, Seoul National University HospitalSong Hee Kim, Bacheolor, Principal investigator, Researcher, Department of Urology, Seoul National University HospitalJae Hyun Jung, MD, Principal investigator, Clinical fellow, Department of Urology, Seoul National University HospitalJung Hoon Lee, MD, Principal investigator, Clinical fellow, Department of Urology, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03597087
- Sponsor's protocol ID
- SeoulNUH_2018_TURBT
- Status last verified
- Jul 2018
- First submitted
- 2 Jul 2018
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Herr HW, Faulkner JR, Grossman HB, Natale RB, deVere White R, Sarosdy MF, Crawford ED. Surgical factors influence bladder cancer outcomes: a cooperative group report. J Clin Oncol. 2004 Jul 15;22(14):2781-9. doi: 10.1200/JCO.2004.11.024. Epub 2004 Jun 15.
PubMed 15199091Christodouleas JP, Baumann BC, He J, Hwang WT, Tucker KN, Bekelman JE, Tangen CM, Lerner SP, Guzzo TJ, Malkowicz SB, Herr H. Optimizing bladder cancer locoregional failure risk stratification after radical cystectomy using SWOG 8710. Cancer. 2014 Apr 15;120(8):1272-80. doi: 10.1002/cncr.28544. Epub 2014 Jan 3.
PubMed 24390799Witjes JA, Comperat E, Cowan NC, De Santis M, Gakis G, Lebret T, Ribal MJ, Van der Heijden AG, Sherif A; European Association of Urology. EAU guidelines on muscle-invasive and metastatic bladder cancer: summary of the 2013 guidelines. Eur Urol. 2014 Apr;65(4):778-92. doi: 10.1016/j.eururo.2013.11.046. Epub 2013 Dec 12.
PubMed 24373477Pollack A, Zagars GK, Cole CJ, Dinney CP, Swanson DA, Grossman HB. The relationship of local control to distant metastasis in muscle invasive bladder cancer. J Urol. 1995 Dec;154(6):2059-63; discussion 2063-4.
PubMed 7500458Jensen JB, Ulhoi BP, Jensen KM. Extended versus limited lymph node dissection in radical cystectomy: impact on recurrence pattern and survival. Int J Urol. 2012 Jan;19(1):39-47. doi: 10.1111/j.1442-2042.2011.02887.x. Epub 2011 Nov 3.
PubMed 22050425Zaghloul MS, Awwad HK, Akoush HH, Omar S, Soliman O, el Attar I. Postoperative radiotherapy of carcinoma in bilharzial bladder: improved disease free survival through improving local control. Int J Radiat Oncol Biol Phys. 1992;23(3):511-7. doi: 10.1016/0360-3016(92)90005-3.
PubMed 1612951Lawton CA, Michalski J, El-Naqa I, Buyyounouski MK, Lee WR, Menard C, O'Meara E, Rosenthal SA, Ritter M, Seider M. RTOG GU Radiation oncology specialists reach consensus on pelvic lymph node volumes for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2009 Jun 1;74(2):383-7. doi: 10.1016/j.ijrobp.2008.08.002. Epub 2008 Oct 22.
PubMed 18947938Baumann BC, Guzzo TJ, He J, Keefe SM, Tucker K, Bekelman JE, Hwang WT, Vaughn DJ, Malkowicz SB, Christodouleas JP. A novel risk stratification to predict local-regional failures in urothelial carcinoma of the bladder after radical cystectomy. Int J Radiat Oncol Biol Phys. 2013 Jan 1;85(1):81-8. doi: 10.1016/j.ijrobp.2012.03.007. Epub 2012 Apr 28.
PubMed 22543204Baumann BC, Guzzo TJ, He J, Vaughn DJ, Keefe SM, Vapiwala N, Deville C, Bekelman JE, Tucker K, Hwang WT, Malkowicz SB, Christodouleas JP. Bladder cancer patterns of pelvic failure: implications for adjuvant radiation therapy. Int J Radiat Oncol Biol Phys. 2013 Feb 1;85(2):363-9. doi: 10.1016/j.ijrobp.2012.03.061. Epub 2012 May 30.
PubMed 22658217Ku JH, Kim M, Jeong CW, Kwak C, Kim HH. Risk prediction models of locoregional failure after radical cystectomy for urothelial carcinoma: external validation in a cohort of korean patients. Int J Radiat Oncol Biol Phys. 2014 Aug 1;89(5):1032-1037. doi: 10.1016/j.ijrobp.2014.04.049. Epub 2014 Jul 8.
PubMed 25035206Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
PubMed 25220842Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
PubMed 25651787Babjuk M, Burger M, Comperat E, Palou J, Roupret M, van Rhijn B, Shariat S, Sylvester R, Zigeuner R, Gontero P, Mostafid H. Reply to Harry Herr's Letter to the Editor re: Marko Babjuk, Andreas Bohle, Maximilian Burger, et al. EAU Guidelines on Non-muscle-invasive Urothelial Carcinoma of the Bladder: Update 2016. Eur Urol 2017;71:447-61. Eur Urol. 2017 Jun;71(6):e173-e174. doi: 10.1016/j.eururo.2016.11.029. Epub 2016 Dec 7. No abstract available.
PubMed 27939074Burger M, Catto JW, Dalbagni G, Grossman HB, Herr H, Karakiewicz P, Kassouf W, Kiemeney LA, La Vecchia C, Shariat S, Lotan Y. Epidemiology and risk factors of urothelial bladder cancer. Eur Urol. 2013 Feb;63(2):234-41. doi: 10.1016/j.eururo.2012.07.033. Epub 2012 Jul 25.
PubMed 22877502Kamat AM, Witjes JA, Brausi M, Soloway M, Lamm D, Persad R, Buckley R, Bohle A, Colombel M, Palou J. Defining and treating the spectrum of intermediate risk nonmuscle invasive bladder cancer. J Urol. 2014 Aug;192(2):305-15. doi: 10.1016/j.juro.2014.02.2573. Epub 2014 Mar 25.
PubMed 24681333
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03597087
- Acronym / sponsor ID
- SeoulNUH_2018_TURBT
- Conditions
- Bladder Cancer
- Keywords
- Anesthesia, Bladder cancer, Recurrence rate, Transurethral resection of bladder mass
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 289 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 19 Jul 2018 (estimated)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| General anesthesia | Experimental | Procedure: Anesthesia before transurethral resection of the bladder tumor, Drug: AnesthesiaGroup of general anesthesia before transurethral resection of the bladder tumor anesthesia: propopol |
| Spinal anesthesia | Experimental | Procedure: Anesthesia before transurethral resection of the bladder tumor, Drug: AnesthesiaGroup of spinal anesthesia before transurethral resection of the bladder tumor anesthesia: bupibacaine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anesthesia before transurethral resection of the bladder tumorGeneral 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 | Procedure or surgery | General anesthesia, Spinal anesthesia |
| AnesthesiaGeneral anaesthesia : propopol Spinal anaesthesia : bupibacaine | Drug | General anesthesia, Spinal anesthesia |
Primary outcome
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.
1 secondary outcome
2-year progression-free survival
Time frame: Follow up every 3 months until 2 years after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Results publication: PubMed 15199091Herr HW, Faulkner JR, Grossman HB, Natale RB, deVere White R, Sarosdy MF, Crawford ED. Surgical factors influence bladder cancer outcomes: a cooperative group report. J Clin Oncol. 2004 Jul 15;22(14):2781-9. doi: 10.1200/JCO.2004.11.024. Epub 2004 Jun 15.
- Results publication: PubMed 24390799Christodouleas JP, Baumann BC, He J, Hwang WT, Tucker KN, Bekelman JE, Tangen CM, Lerner SP, Guzzo TJ, Malkowicz SB, Herr H. Optimizing bladder cancer locoregional failure risk stratification after radical cystectomy using SWOG 8710. Cancer. 2014 Apr 15;120(8):1272-80. doi: 10.1002/cncr.28544. Epub 2014 Jan 3.
- Results publication: PubMed 24373477Witjes JA, Comperat E, Cowan NC, De Santis M, Gakis G, Lebret T, Ribal MJ, Van der Heijden AG, Sherif A; European Association of Urology. EAU guidelines on muscle-invasive and metastatic bladder cancer: summary of the 2013 guidelines. Eur Urol. 2014 Apr;65(4):778-92. doi: 10.1016/j.eururo.2013.11.046. Epub 2013 Dec 12.
- Results publication: PubMed 7500458Pollack A, Zagars GK, Cole CJ, Dinney CP, Swanson DA, Grossman HB. The relationship of local control to distant metastasis in muscle invasive bladder cancer. J Urol. 1995 Dec;154(6):2059-63; discussion 2063-4.
- Results publication: PubMed 22050425Jensen JB, Ulhoi BP, Jensen KM. Extended versus limited lymph node dissection in radical cystectomy: impact on recurrence pattern and survival. Int J Urol. 2012 Jan;19(1):39-47. doi: 10.1111/j.1442-2042.2011.02887.x. Epub 2011 Nov 3.
- Results publication: PubMed 1612951Zaghloul MS, Awwad HK, Akoush HH, Omar S, Soliman O, el Attar I. Postoperative radiotherapy of carcinoma in bilharzial bladder: improved disease free survival through improving local control. Int J Radiat Oncol Biol Phys. 1992;23(3):511-7. doi: 10.1016/0360-3016(92)90005-3.
- Results publication: PubMed 18947938Lawton CA, Michalski J, El-Naqa I, Buyyounouski MK, Lee WR, Menard C, O'Meara E, Rosenthal SA, Ritter M, Seider M. RTOG GU Radiation oncology specialists reach consensus on pelvic lymph node volumes for high-risk prostate cancer. Int J Radiat Oncol Biol Phys. 2009 Jun 1;74(2):383-7. doi: 10.1016/j.ijrobp.2008.08.002. Epub 2008 Oct 22.
- Results publication: PubMed 22543204Baumann BC, Guzzo TJ, He J, Keefe SM, Tucker K, Bekelman JE, Hwang WT, Vaughn DJ, Malkowicz SB, Christodouleas JP. A novel risk stratification to predict local-regional failures in urothelial carcinoma of the bladder after radical cystectomy. Int J Radiat Oncol Biol Phys. 2013 Jan 1;85(1):81-8. doi: 10.1016/j.ijrobp.2012.03.007. Epub 2012 Apr 28.
- Results publication: PubMed 22658217Baumann BC, Guzzo TJ, He J, Vaughn DJ, Keefe SM, Vapiwala N, Deville C, Bekelman JE, Tucker K, Hwang WT, Malkowicz SB, Christodouleas JP. Bladder cancer patterns of pelvic failure: implications for adjuvant radiation therapy. Int J Radiat Oncol Biol Phys. 2013 Feb 1;85(2):363-9. doi: 10.1016/j.ijrobp.2012.03.061. Epub 2012 May 30.
- Results publication: PubMed 25035206Ku JH, Kim M, Jeong CW, Kwak C, Kim HH. Risk prediction models of locoregional failure after radical cystectomy for urothelial carcinoma: external validation in a cohort of korean patients. Int J Radiat Oncol Biol Phys. 2014 Aug 1;89(5):1032-1037. doi: 10.1016/j.ijrobp.2014.04.049. Epub 2014 Jul 8.
- Results publication: PubMed 25220842Ferlay J, Soerjomataram I, Dikshit R, Eser S, Mathers C, Rebelo M, Parkin DM, Forman D, Bray F. Cancer incidence and mortality worldwide: sources, methods and major patterns in GLOBOCAN 2012. Int J Cancer. 2015 Mar 1;136(5):E359-86. doi: 10.1002/ijc.29210. Epub 2014 Oct 9.
- Results publication: PubMed 25651787Torre LA, Bray F, Siegel RL, Ferlay J, Lortet-Tieulent J, Jemal A. Global cancer statistics, 2012. CA Cancer J Clin. 2015 Mar;65(2):87-108. doi: 10.3322/caac.21262. Epub 2015 Feb 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jin Tae Kim, PhD study director
Professor, Department of Anesthesiology, Seoul National University Hospital
Ja Hyeon Ku, PhD study chair
Professor, Department of Urology, Seoul National University Hospital
Hyeong Dong Yuk, MD principal investigator
Clinical fellow, Department of Urology, Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anesthesia before transurethral resection of the bladder tumor and Anesthesia in people with Bladder Cancer, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hyeong Dong Yuk, MD (+82-2-2072-1968, hinayuk@naver.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
2-year recurrence-free survival rate (time frame: Follow up every 3 months until 2 years after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03597087, which also lists 24 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.