Comparison Capsule Sparing Cystectomy and Radical Cystoprostatectomy in Men with Bladder Cancer

NCT05067101 | Recruiting

• 1 other identifier: ZJH-CSC003
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 1

Brief Summary

Bladder cancer is a common malignant tumor of the urinary system, radical resection plus urinary diversion is the first choice of treatment for muscle invasive bladder cancer. Urinary diversion of surgical options related to patient'survival and quality of life. 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.

Conditions

Bladder Cancer

Keywords

bladder cancer; detaenial sigmoid neobladder; prostate capsule sparing

Outcome Measures

Primary Outcomes (1)

• Post-operative urinary function

  Assess post-operative urinary function using the bladder cancer index (BCI) at the 12th month after surgery

  At the 12th month after surgery

Secondary Outcomes (5)

• bladder cancer specific survival rate

  36 months

• Sexual function

  36 months

• Intraoperative conditions

  24 hour

• Early postoperative rehabilitation indicators

  30 days after surgery

• Rate of serious complications

  36 months

Study Arms (2)

Capsule Sparing Cystectomy

EXPERIMENTAL

Patients undergoing transurethral resection and enucleation of the prostate before laparoscopic cystectomy

Procedure: Capsule Sparing Cystectomy (CSC)

Conventional Radical Cystoprostatectomy

PLACEBO COMPARATOR

Patients undergoing conventional radical cystoprostatectomy

Procedure: Conventional Radical Cystoprostatectomy (CRC)

Interventions

Capsule Sparing Cystectomy (CSC) PROCEDURE

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

Capsule Sparing Cystectomy

Conventional Radical Cystoprostatectomy (CRC) PROCEDURE

According to the consensus standard program, remove the accessory tissues including the bladder, prostate and seminal vesicles

Conventional Radical Cystoprostatectomy

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: only male patient have prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult males aged 20 and above and healthy volunteers are not accepted;
• 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.

You may not qualify if:

• Preoperative serum creatinine more than 2.26mg/dl Or 200μmol/L.
• 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.

Sponsors & Collaborators

• Zhujiang Hospital: lead

Study Sites (1)

Chunxiao Liu

Guangzhou, Guangdong, 510282, China

RECRUITING

Related Publications (12)

• 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.

  PMID: 35020204 BACKGROUND

• 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.

  PMID: 32360052 BACKGROUND

• 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.

  PMID: 23538237 BACKGROUND

• 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.

  PMID: 23290142 BACKGROUND

• 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.

  PMID: 36050131 BACKGROUND

• 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.

  PMID: 25066875 BACKGROUND

• 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.

  PMID: 28495555 BACKGROUND

• 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.

  PMID: 20952005 BACKGROUND

• 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.

  PMID: 35938386 BACKGROUND

• 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.

  PMID: 17366596 BACKGROUND

• 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.

  PMID: 20299056 BACKGROUND

• 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.

  PMID: 19638912 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Chunxiao Liu, doctor

  Southern Medical University, China

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chunxiao Liu, doctor

CONTACT

+86 13302296795; liuchx888@163.com

Peng Xu, doctor

CONTACT

+86 18665073650; yihuixp88@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor;Chief Surgeon

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: October 5, 2021
• Study Start: September 10, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 4, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)