NCT05067101Recruiting
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
Source: ClinicalTrials.gov · Last updated 9 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 126 (estimated)
- First submitted
- 22 Sept 2021
- Start date
- 10 Sept 2024
- Primary completion date
- 1 Dec 2028
- Lead sponsor
- Zhujiang Hospital
- Diseases
- Bladder cancer
- NCT number
- NCT05067101
What you commit to
- Study type: Interventional
- Planned participants: 126
- From 10 Sept 2024 to the primary completion date, 1 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Cancer invaded prostate or urethral (confirmed by the pathology).
- 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.
Lab values
- Preoperative serum creatinine more than 2.26mg/dl Or 200μmol/L.
Other
- Patients with distant metastasis.
Who the study is looking for
- 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.
Age in the registry: 20 years to - · Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Chunxiao Liu Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.