Comparison Capsule Sparing Cystectomy and Radical Cystoprostatectomy in Men with Bladder Cancer
NCT ID: NCT05067101
Last Updated: 2024-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
126 participants
INTERVENTIONAL
2024-09-10
2026-12-01
Brief Summary
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In 2000, professor Chunxiao Liu invented "detaenial sigmoid neobladder", this surgical method overset the traditional intestinal detubularization approach, which detached the serosal layer with smooth muscle from the bowel without split it. This kind of neobladder is easier to construct and have less impact on intestinal function. So far, it has been implemented for more than 700 cases in Zhujiang hospital, the age of patients range from 9 months (bladder rhabdomyosarcoma) to 88 years old.
The filed of standard radical bladder cancer resection includes the structure of the prostate and seminal vesicles. More and more studies and long-term clinical experience in our hospital have confirmed that capsule sparing cystectomy can achieve good tumor control and excellent functional recovery.
Our project is going to perform a randomized controlled trial for capsule sparing cystectomy and conventional radical cystoprostatectomy and look forward to assess the oncology outcome and functional recovery of these two procedures which provide an objective basis for the patients undergoing orthotopic urinary diversion in the future.
Detailed Description
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CRC group：patients undergoing conventional radical cystoprostatectomy. All the patients undergoing detaenial sigmoid neobladder after cystectomy and accept at least 36 months follow up.
Followup: Patients were followed up at every 3-6 mo after surgery in the first 2 yr. The last follow-up was in the 36th month. Biochemical examination、blood and urine routine tests were done every 3 to 12 months. Urodynamic investigation, cystoscopic examination, pelvic computerized tomography, renal dynamic imaging and retro-cystogram were also performed every 3 to 12 months postoperatively.
Postoperative complications were classified as early (90 days or less) and late (greater than 90 days). Early and late complications were subdivided into those related and not related to the neobladder. Complication grade was classified according to the Clavien-Dindo system. Major complications were defined as grade III or higher.
During the follow-up period, patients were asked about daytime and night-time continence and erectile function (EF). Bladder Cancer Index and International Index of Erectile Function-5 (IIEF-5) are designed to evaluate patients' urinary control and sexual function
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Capsule Sparing Cystectomy
Patients undergoing transurethral resection and enucleation of the prostate before laparoscopic cystectomy
Capsule Sparing Cystectomy (CSC)
Adopt endoscopic enucleation technology to preserve the prostate capsule and part of the urinary control support structure to help restore urinary control and erectile functions
Conventional Radical Cystoprostatectomy
Patients undergoing conventional radical cystoprostatectomy
Conventional Radical Cystoprostatectomy (CRC)
According to the consensus standard program, remove the accessory tissues including the bladder, prostate and seminal vesicles
Interventions
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Capsule Sparing Cystectomy (CSC)
Adopt endoscopic enucleation technology to preserve the prostate capsule and part of the urinary control support structure to help restore urinary control and erectile functions
Conventional Radical Cystoprostatectomy (CRC)
According to the consensus standard program, remove the accessory tissues including the bladder, prostate and seminal vesicles
Eligibility Criteria
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Inclusion Criteria
* Recurrent bladder cancer: recurrent NMIBC after treatment and Carcinoma in situ that does not respond to BCG vaccine treatment.
* ECOG score is 0 or 1.
* Voluntarily signed the informed consent.
Exclusion Criteria
* Cancer invaded prostate or urethral (confirmed by the pathology).
* Patients with distant metastasis.
* Abnormal PSA level, or suspected patients with unconfirmed prostate cancer .
* A history of other malignant tumors within three years.
* sigmoid chronic inflammation, like ulcerative colitis or intestinal tuberculosis, and so on.
* Severe cardiopulmonary and liver dysfunction, combined with other serious diseases
* Other conditions that have been approved by a urologist for not suitable for neobladder surgery.
20 Years
MALE
No
Sponsors
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Zhujiang Hospital
OTHER
Responsible Party
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Chunxiao Liu
Professor;Chief Surgeon
Principal Investigators
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Chunxiao Liu, doctor
Role: PRINCIPAL_INVESTIGATOR
Southern Medical University, China
Locations
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Chunxiao Liu
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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Siegel RL, Miller KD, Fuchs HE, Jemal A. Cancer statistics, 2022. CA Cancer J Clin. 2022 Jan;72(1):7-33. doi: 10.3322/caac.21708. Epub 2022 Jan 12.
Witjes JA, Bruins HM, Cathomas R, Comperat EM, Cowan NC, Gakis G, Hernandez V, Linares Espinos E, Lorch A, Neuzillet Y, Rouanne M, Thalmann GN, Veskimae E, Ribal MJ, van der Heijden AG. European Association of Urology Guidelines on Muscle-invasive and Metastatic Bladder Cancer: Summary of the 2020 Guidelines. Eur Urol. 2021 Jan;79(1):82-104. doi: 10.1016/j.eururo.2020.03.055. Epub 2020 Apr 29.
Xu K, Liu CX, Zheng SB, Li HL, Xu YW, Xu AB, Chen BS, Shen HY. Orthotopic detaenial sigmoid neobladder after radical cystectomy: technical considerations, complications and functional outcomes. J Urol. 2013 Sep;190(3):928-34. doi: 10.1016/j.juro.2013.03.072. Epub 2013 Mar 26.
Xu A, Li B, Li H, Zheng S, Du W, Xu Y, Zou Y, Luo Q, Liu C. Comparison of seromuscular tunnel and split-cuff nipple antireflux ureteroenteral anastomosis techniques in orthotopic taenia myectomy sigmoid neobladder: a prospective, randomized study. Urology. 2013 Mar;81(3):669-74. doi: 10.1016/j.urology.2012.11.018. Epub 2013 Jan 3.
Xu P, Chen C, Chen B, Bi E, Du W, Jiang N, Liu Z, Lan H, Cao M, Liu Y, Huang J, Shen H, Liu C, Liu C, Xu A. Long-term Follow-up of Detaenial Sigmoid Neobladder Reconstruction for Paediatric Patients with Bladder and Prostate Rhabdomyosarcoma: Technique and Results from a Single High-volume Centre. Eur Urol. 2022 Nov;82(5):543-550. doi: 10.1016/j.eururo.2022.08.015. Epub 2022 Aug 30.
Jacobs BL, Daignault S, Lee CT, Hafez KS, Montgomery JS, Montie JE, Humrich JE, Hollenbeck BK, Wood DP Jr, Weizer AZ. Prostate capsule sparing versus nerve sparing radical cystectomy for bladder cancer: results of a randomized, controlled trial. J Urol. 2015 Jan;193(1):64-70. doi: 10.1016/j.juro.2014.07.090. Epub 2014 Jul 24.
Hernandez V, Espinos EL, Dunn J, MacLennan S, Lam T, Yuan Y, Comperat E, Cowan NC, Gakis G, Lebret T, van der Heijden AG, Witjes JA, Ribal MJ. Oncological and functional outcomes of sexual function-preserving cystectomy compared with standard radical cystectomy in men: A systematic review. Urol Oncol. 2017 Sep;35(9):539.e17-539.e29. doi: 10.1016/j.urolonc.2017.04.013. Epub 2017 May 8.
Liu C, Zheng S, Li H, Xu K. Transurethral enucleation and resection of prostate in patients with benign prostatic hyperplasia by plasma kinetics. J Urol. 2010 Dec;184(6):2440-5. doi: 10.1016/j.juro.2010.08.037. Epub 2010 Oct 16.
Chen P, Xu P, Liu C. Long-term outcomes of bipolar transurethral enucleation and resection of the prostate on patients with benign prostatic obstruction: a 10-year follow-up. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2023 Dec;167(4):340-346. doi: 10.5507/bp.2022.034. Epub 2022 Jul 18.
Gilbert SM, Wood DP, Dunn RL, Weizer AZ, Lee CT, Montie JE, Wei JT. Measuring health-related quality of life outcomes in bladder cancer patients using the Bladder Cancer Index (BCI). Cancer. 2007 May 1;109(9):1756-62. doi: 10.1002/cncr.22556.
Gilbert SM, Dunn RL, Hollenbeck BK, Montie JE, Lee CT, Wood DP, Wei JT. Development and validation of the Bladder Cancer Index: a comprehensive, disease specific measure of health related quality of life in patients with localized bladder cancer. J Urol. 2010 May;183(5):1764-9. doi: 10.1016/j.juro.2010.01.013. Epub 2010 Mar 17.
Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.
Other Identifiers
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ZJH-CSC003
Identifier Type: -
Identifier Source: org_study_id