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

March 11, 2024 updated by: Chunxiao Liu, Zhujiang Hospital

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

CSC group：patients undergoing transurethral resection and enucleation of the prostate first, do not open the bladder neck to maintain the integrity of the bladder neck. The enucleated prostate capsule is preserved under laparoscopic surgery, and the urinary catheter is stretched during the operation to avoid implantation and metastasis.

CRC group：patients undergoing conventional radical cystoprostatectomy. All the patients undergoing detaenial sigmoid neobladder after cystectomy and accept at least 36 months follow up.

Followup: Patients were followed up at every 3-6 mo after surgery in the first 2 yr. The last follow-up was in the 36th month. Biochemical examination、blood and urine routine tests were done every 3 to 12 months. Urodynamic investigation, cystoscopic examination, pelvic computerized tomography, renal dynamic imaging and retro-cystogram were also performed every 3 to 12 months postoperatively.

Postoperative complications were classified as early (90 days or less) and late (greater than 90 days). Early and late complications were subdivided into those related and not related to the neobladder. Complication grade was classified according to the Clavien-Dindo system. Major complications were defined as grade III or higher.

During the follow-up period, patients were asked about daytime and night-time continence and erectile function (EF). Bladder Cancer Index and International Index of Erectile Function-5 (IIEF-5) are designed to evaluate patients' urinary control and sexual function

Study Type

Interventional

Enrollment (Estimated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510282
        • Recruiting
        • Chunxiao Liu
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Capsule Sparing Cystectomy
Patients undergoing transurethral resection and enucleation of the prostate before laparoscopic cystectomy
Procedure: Capsule 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
Placebo Comparator: Conventional Radical Cystoprostatectomy
Patients undergoing conventional radical cystoprostatectomy
Procedure: Conventional Radical Cystoprostatectomy (CRC)
According to the consensus standard program, remove the accessory tissues including the bladder, prostate and seminal vesicles

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative urinary function
Time Frame: At the 12th month after surgery
Assess post-operative urinary function using the bladder cancer index (BCI) at the 12th month after surgery
At the 12th month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bladder cancer specific survival rate
Time Frame: 36 months
Determine bladder cancer control with CSC compared to CRC as measured by margin status and time to disease recurrence
36 months
Sexual function
Time Frame: 36 months
Assess post-operative sexual function using IIEF-5 score
36 months
Intraoperative conditions
Time Frame: 24 hour
Including surgical time, bleeding volume, blood transfusion volume, etc.
24 hour
Early postoperative rehabilitation indicators
Time Frame: 30 days after surgery
Including intensive care time, time to restore full flow diet, hospitalization time, drainage tube removal time, visual pain score, etc
30 days after surgery
Rate of serious complications
Time Frame: 36 months
Assess rate of serious complications using Clavien Dindo Complication Grading System
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zhujiang Hospital

Investigators

  • Principal Investigator: Chunxiao Liu, doctor, Southern Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2024

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

September 22, 2021

First Submitted That Met QC Criteria

September 22, 2021

First Posted (Actual)

October 5, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 11, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ZJH-CSC003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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