RecruitingNot ApplicableNCT05067101

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

A Randomized Controlled Study to Compare the Oncology Outcome and Functional Recovery of Capsule Sparing Cystectomy and Radical Cystoprostatectomy with Detaenial Sigmoid Neobladder in Men Suffering from Bladder Cancer


Sponsor

Zhujiang Hospital

Enrollment

126 participants

Start Date

Sep 10, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: MALEMin Age: 20 Years

Inclusion Criteria4

  • 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.

Exclusion Criteria8

  • 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.

Interventions

PROCEDURECapsule 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

PROCEDUREConventional Radical Cystoprostatectomy (CRC)

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


Locations(1)

Chunxiao Liu

Guangzhou, Guangdong, China

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NCT05067101


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