Actively Recruiting

Phase Not Applicable
Age: 18Years - 100Years
All Genders
NCT03108196

Comparison of Safety and Efficacy of Detaenial Sigmoid Neobladder and Ileal Neobladder

Led by Zhujiang Hospital · Updated on 2024-12-04

96

Participants Needed

1

Research Sites

386 weeks

Total Duration

On this page

Sponsors

Z

Zhujiang Hospital

Lead Sponsor

S

Sun Yat-Sen University Cancer Center

Collaborating Sponsor

AI-Summary

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 1988, Hautmann firstly reported an orthotopic urinary diversion method: Hautmann neobladder. As the urine can be controlled from the original urethra, the patient's quality of life has been greatly improved, so the new bladder surgery gradually accepted and welcomed by urologists and patients. However, in order to achieve low-pressure and large-volume storage capacity of the urine reservoir, the 40-70cm long interception of terminal ileum need to be detubularized. Only after split, folded, re-stitched and a series of treatment, the intestinal can be used. Such complicated procedures make so many urologists give it up. In addition, the interception of the long ileum may lead to reduced absorption of vitamin B12 which caused anemia, metabolic acidosis, intestinal dysfunction. Not only that, as time goes by, this kind of neobladder will be unlimited expansion and resulting in a serious increase in residual urine volume, hydronephrosis, or even the occurrence of neobladder spontaneous rupture. 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 600 cases in Zhujiang hospital, the age of patients range from 9 months (bladder rhabdomyosarcoma) to 84 years old. So far as now, no multicenter prospective clinical study on orthotopic urinary diversion has been performed worldwide, neither the head-to-head studies on detaenial sigmoid neobladder and ileal neobladder. Our project is going to perform a multicenter randomized controlled trial for these two neobladder methods and look forward to assess the safety and efficacy of these two procedures which provide an objective basis for the patients undergoing orthotopic urinary diversion in the future.

CONDITIONS

Official Title

Comparison of Safety and Efficacy of Detaenial Sigmoid Neobladder and Ileal Neobladder

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Bladder carcinoma in situ, including CIS and T1G3 tumor, muscle invasive bladder cancer (T2/T3N0-1M0)
  • Recurrent bladder cancer
  • Other conditions approved by a urologist for new bladder surgery
  • Previous intravesical chemotherapy, intra-arterial infusion chemotherapy, or systemic chemotherapy
  • Voluntarily signed informed consent
Not Eligible

You will not qualify if you...

  • Preoperative serum creatinine more than 2.26 mg/dl (or 200 bcmol/L)
  • Cancer invasion of urethra confirmed by pathology
  • Patients without bladder cancer who underwent neobladder
  • History of other malignant tumors within five years
  • Chronic inflammation of ileum or sigmoid, such as ulcerative colitis or intestinal tuberculosis
  • Other conditions approved by a urologist as unsuitable for new bladder surgery

AI-Screening

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Trial Site Locations

Total: 1 location

1

Zhujiang Hospital

Guangzhou, Guangdong, China, 510282

Actively Recruiting

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Research Team

A

Abai Xu, doctor

CONTACT

P

Peng Xu, doctor

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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