CClinicalTrials.gg
Status unknownNCT03597087Updated Jul 24, 2018

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

An interventional study of Anesthesia before transurethral resection of the bladder tumor and Anesthesia in Bladder Cancer, sponsored by Seoul National University Hospital. Status unknown at 1 site in Korea, Republic of. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-07-24.

Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2018), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
289
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

    1. 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
02

Conditions studied

  • Bladder Cancer

Keywords

  • Anesthesia, Bladder cancer, Recurrence rate, Transurethral resection of bladder mass
03

In context

Urinary Bladder Neoplasms

1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.

This study's planned enrollment of 289 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.

Browse Urinary Bladder Neoplasms studies →

Lead sponsor

Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
289 participants (estimated)

Study arms

  • 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 · Drug: Anesthesia

  • 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 · Drug: Anesthesia

Interventions

  • ProcedureAnesthesia 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

  • DrugAnesthesia

    General anaesthesia : propopol Spinal anaesthesia : bupibacaine

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Follow up every 3 months until 2 years after surgery

07

Study locations

1 site
  • Seoul National University Hospital
    Seoul, 110-744, Korea, Republic of
08

References and documents

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 15199091 ↗
  • Christodouleas 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. Erratum In: Cancer. 2015 Jan 1;121(1):162. Herr, Harry [added]. PubMed 24390799 ↗
  • Witjes 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 24373477 ↗
  • Pollack 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 7500458 ↗
  • Jensen 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 22050425 ↗
  • Zaghloul 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 1612951 ↗
  • Lawton 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 18947938 ↗
  • Baumann 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 22543204 ↗
  • Baumann 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 22658217 ↗
  • Ku 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 25035206 ↗
  • Ferlay 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 25220842 ↗
  • Torre 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 25651787 ↗
  • Babjuk 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 27939074 ↗
  • Burger 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 22877502 ↗
  • Kamat 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 ↗
  • Hall MC, Chang SS, Dalbagni G, Pruthi RS, Seigne JD, Skinner EC, Wolf JS Jr, Schellhammer PF. Guideline for the management of nonmuscle invasive bladder cancer (stages Ta, T1, and Tis): 2007 update. J Urol. 2007 Dec;178(6):2314-30. doi: 10.1016/j.juro.2007.09.003. No abstract available. PubMed 17993339 ↗
  • Morales A, Eidinger D, Bruce AW. Intracavitary Bacillus Calmette-Guerin in the treatment of superficial bladder tumors. J Urol. 1976 Aug;116(2):180-3. doi: 10.1016/s0022-5347(17)58737-6. PubMed 820877 ↗
  • Balkwill F, Mantovani A. Inflammation and cancer: back to Virchow? Lancet. 2001 Feb 17;357(9255):539-45. doi: 10.1016/S0140-6736(00)04046-0. PubMed 11229684 ↗
  • Grivennikov SI, Greten FR, Karin M. Immunity, inflammation, and cancer. Cell. 2010 Mar 19;140(6):883-99. doi: 10.1016/j.cell.2010.01.025. PubMed 20303878 ↗
  • Kim HS, Ku JH. Systemic Inflammatory Response Based on Neutrophil-to-Lymphocyte Ratio as a Prognostic Marker in Bladder Cancer. Dis Markers. 2016;2016:8345286. doi: 10.1155/2016/8345286. Epub 2016 Jan 5. PubMed 26880857 ↗
  • Crumley AB, McMillan DC, McKernan M, Going JJ, Shearer CJ, Stuart RC. An elevated C-reactive protein concentration, prior to surgery, predicts poor cancer-specific survival in patients undergoing resection for gastro-oesophageal cancer. Br J Cancer. 2006 Jun 5;94(11):1568-71. doi: 10.1038/sj.bjc.6603150. PubMed 16685271 ↗
  • Dutta S, Crumley AB, Fullarton GM, Horgan PG, McMillan DC. Comparison of the prognostic value of tumour and patient related factors in patients undergoing potentially curative resection of gastric cancer. Am J Surg. 2012 Sep;204(3):294-9. doi: 10.1016/j.amjsurg.2011.10.015. Epub 2012 Mar 22. PubMed 22444831 ↗
  • Kweon TD, Lee KY. Spinal anesthesia is associated with lower recurrence rates after resection of non-muscle invasive bladder cancer. Transl Androl Urol. 2018 Apr;7(2):283-286. doi: 10.21037/tau.2018.03.13. No abstract available. PubMed 29733090 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03597087
Lead sponsor
Seoul National University Hospital
Responsible party
Ja Hyeon Ku (Professor, MD., PHD., Seoul National University Hospital) — Principal investigator
First posted
Jul 24, 2018
Start date
Jul 19, 2018 (estimated)
Primary completion
Jul 1, 2021 (estimated)
Completion
Dec 31, 2022 (estimated)
Last update
Jul 24, 2018

Study contacts

Hyeong Dong Yuk, MD
Contact
hinayuk@naver.com
+82-2-2072-1968
Song Hee Kim, Bacheolo
Contact
songheekim0506@gmail.com
+82-2-2072-1968
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
Song Hee Kim, Bacheolor
principal investigator · Researcher, Department of Urology, Seoul National University Hospital
Jae Hyun Jung, MD
principal investigator · Clinical fellow, Department of Urology, Seoul National University Hospital
Jung Hoon Lee, MD
principal investigator · Clinical fellow, Department of Urology, Seoul National University Hospital

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion