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

Trial details

Who runs it

Zhujiang Hospital

Trial code

NCT03108196

Record updated

9 October 2026

Original description

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.Read full original descriptionShow less

A Multicenter Randomized Controlled Study to Compare the Safety and Efficacy of Detaenial Sigmoid Neobladder and Hautmann Ileal Neobladder in Patients With 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 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.

Inclusion: Bladder carcinoma in situ, include CIS and T1G3 tumor, muscle invasive bladder cancer（T2/T3N0-1M0）; Recurrent bladder cancer; Other conditions that have been approved by a urologist for indications for new bladder surgery; Had been received intravesical chemotherapy, intra-arterial infusion chemotherapy or systemic chemotherapy in the past; Voluntarily signed the informed consent -.

Exclusion: Cancer invaded urethral (confirmed by the pathology); Non - bladder cancer patients underwent neobladder; A history of other malignant tumors within five years; Ileum / sigmoid chronic inflammation, like ulcerative colitis or intestinal tuberculosis, and so on; Other conditions that have been approved by a urologist for not suitable for new bladder surgery; -; Preoperative serum creatinine more than 2.26mg/dl（Or 200μmol/L）.

ClinicalTrials.gov NCT03108196