Comparison Capsule Sparing Cystectomy and Radical Cystoprostatectomy in Men with Bladder Cancer
Recruiting · NCT05067101 · Interventional (participants receive a specific treatment) · Lead sponsor: Zhujiang Hospital
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
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.
Where it is running
1 location listed.
- Chunxiao Liu - Guangzhou, Guangdong, China