NCT05067101 Comparison Capsule Sparing Cystectomy and Radical Cystoprostatectomy in Men with Bladder Cancer
| NCT ID | NCT05067101 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhujiang Hospital |
| Condition | Bladder Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 126 participants |
| Start Date | 2024-09-10 |
| Primary Completion | 2025-12-01 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 126 participants in total. It began in 2024-09-10 with a primary completion date of 2025-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * Adult males aged 20 and above and healthy volunteers are not accepted; * Bladder carcinoma in situ、T1G3 tumor、muscle invasive bladder cancer with clinical stage of cT2-T3N0M0 (If the clinical staging before neoadjuvant therapy meets the inclusion criteria, patients who have decreased to below cT2 after neoadjuvant therapy can also choose to be included according to the patient's wishes). * 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: * 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.
Contact & Investigator
Chunxiao Liu, doctor
PRINCIPAL INVESTIGATOR
Southern Medical University, China
Frequently Asked Questions
Who can join the NCT05067101 clinical trial?
This trial is open to male participants only, aged 20 Years or older, studying Bladder Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05067101 currently recruiting?
Yes, NCT05067101 is actively recruiting participants. Contact the research team at liuchx888@163.com for enrollment information.
Where is the NCT05067101 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT05067101 clinical trial?
NCT05067101 is sponsored by Zhujiang Hospital. The principal investigator is Chunxiao Liu, doctor at Southern Medical University, China. The trial plans to enroll 126 participants.
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