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

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.

Timeline

Start

2018-07-19

Primary completion

2021-07-01

Completion

2022-12-31

Outcome

Met primary endpoint

paper Time-to-event analysis showed a significantly lower recurrence of NMIBC in the SA group than in the GA group PMID 39740955 ↗

Publications

• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Results 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.
• Han JH, Yuk HD, Jeong SH, Jeong CW, Kwak C, Kim JT, Ku JH. Anesthetic approaches and 2-year recurrence rates in non-muscle invasive bladder cancer: a randomized clinical trial. Reg Anesth Pain Med. 2026 Apr 2;51(4):379-384. doi: 10.1136/rapm-2024-105949.

Drugs

Indications