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

ConditionBladder Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age20+
SponsorZhujiang Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 .

Trial design

Design model

Parallel

Treatments tested in this trial

  • Capsule Sparing Cystectomy (CSC)

    Procedure/Surgery

    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

  • Conventional Radical Cystoprostatectomy (CRC)

    Procedure/Surgery

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

Treatment groups

126 Participants
are divided into 2 treatment groups
Group A: Capsule Sparing CystectomyExperimental treatment 1 intervention
Group B: Conventional Radical CystoprostatectomyPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Post-operative urinary function

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

Time frame
At the 12th month after surgery

Secondary outcomes

1

bladder cancer specific survival rate

Determine bladder cancer control with CSC compared to CRC as measured by margin status and time to disease recurrence

Time frame
36 months
2

Sexual function

Assess post-operative sexual function using IIEF-5 score

Time frame
36 months
3

Intraoperative conditions

Including surgical time, bleeding volume, blood transfusion volume, etc.

Time frame
24 hour
4

Early postoperative rehabilitation indicators

Including intensive care time, time to restore full flow diet, hospitalization time, drainage tube removal time, visual pain score, etc

Time frame
30 days after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zhujiang Hospital

Lead sponsor

Source ClinicalTrials.gov
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