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

NCT03108196 | Recruiting

• 1 other identifier: LC2016PY030
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

Brief Summary

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

Bladder Cancer; Urinary Diversion

Keywords

bladder cancer， neobladder, detaenial sigmoid, ileal

Outcome Measures

Primary Outcomes (1)

• Post void residual volume of neobladder

  Residual urine volume after spontaneous urination with urinary diversion in the 36th month

  the 36th month

Secondary Outcomes (3)

• Time cost

  24 hour

• EBL

  24 hour

• Short term complications

  90 day postoperative

Study Arms (2)

sigmoid

EXPERIMENTAL

Use 15 cm detaenial sigmoid colon to reconstructed a "U" shape neobladder after radical cystectomy.

Procedure: sigmoid

ileal

EXPERIMENTAL

Use 70 cm distal ileal segment to reconstructed a "spherical" shape neobladder after radical cystectomy.

Procedure: ileal

Interventions

sigmoid PROCEDURE

The serosal layer with smooth muscle was detached from a 15 cm sigmoid segment submucosal layer and removed continuously. Only the mucosal and submucosal layers were preserved. Approximately 2 cm of the taeniae and serosal layer were preserved to strengthen the urethra-neobladder anastomosis at the central portion of the isolated sigmoid and at the two ends for the ureter-neobladder anastomosis. The ureters were subsequently implanted in antirefluxing fashion in a submucosal tunnel. The ureter-neobladder anastomoses were protected with a 6Fr Single J® stent. The two ends of the sigmoid were closed with the embedded seromuscular layer. The neobladder was anastomosed to the urethra after that.

sigmoid

ileal PROCEDURE

The isolated 70 cm terminal ileum segment is arranged in either an M or W shape and is opened along the antimesenteric border except for a 5 cm section where the incision is curved to make a U-shaped flap. The four limbs of the M or W are then sutured to one another with a running absorbable suture. A small full-thickness segment of bowel is excised for the urethral anastomosis. Once the ileal neobladder is situated and the urethral sutures are tied, the ureters are implanted from inside the neobladder through a small incision in the ileum. The remaining portion of the anterior wall is then closed with a running absorbable suture. Ureteroileal anastomosis were performed with a freely refluxing, open end-to-side method at each end of the W.

ileal

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• Preoperative serum creatinine more than 2.26mg/dl（Or 200μmol/L）
• 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

Sponsors & Collaborators

• Zhujiang Hospital: lead
• Sun Yat-sen University: collaborator
• The Third Affiliated Hospital of Southern Medical University: collaborator
• Fourth Affiliated Hospital of Guangxi Medical University: collaborator
• Ludwig-Maximilians - University of Munich: collaborator

Study Sites (1)

Zhujiang Hospital

Guangzhou, Guangdong, 510282, China

RECRUITING

Related Publications (12)

• Siegel RL, Miller KD, Jemal A. Cancer statistics, 2016. CA Cancer J Clin. 2016 Jan-Feb;66(1):7-30. doi: 10.3322/caac.21332. Epub 2016 Jan 7.

  PMID: 26742998 BACKGROUND

• Witjes JA, Comperat E, Cowan NC, De Santis M, Gakis G, Lebret T, Ribal MJ, Van der Heijden AG, Sherif A; European Association of Urology. EAU guidelines on muscle-invasive and metastatic bladder cancer: summary of the 2013 guidelines. Eur Urol. 2014 Apr;65(4):778-92. doi: 10.1016/j.eururo.2013.11.046. Epub 2013 Dec 12.

  PMID: 24373477 BACKGROUND

• Hautmann RE, Egghart G, Frohneberg D, Miller K. The ileal neobladder. J Urol. 1988 Jan;139(1):39-42. doi: 10.1016/s0022-5347(17)42283-x.

  PMID: 3336101 BACKGROUND

• Zerhau P, Husar M. [Mucus production consequences in cystoplasties and continent urinary diversions in children--long term experiences]. Rozhl Chir. 2006 Mar;85(3):148-50. Czech.

  PMID: 16689148 BACKGROUND

• Haupt G, Pannek J, Knopf HJ, Schulze H, Senge T. Rupture of ileal neobladder due to urethral obstruction by mucous plug. J Urol. 1990 Sep;144(3):740-1. doi: 10.1016/s0022-5347(17)39571-x.

  PMID: 2388342 BACKGROUND

• Xu K, Liu CX, Zheng SB, Li HL, Xu YW, Xu AB, Chen BS, Shen HY. Orthotopic detaenial sigmoid neobladder after radical cystectomy: technical considerations, complications and functional outcomes. J Urol. 2013 Sep;190(3):928-34. doi: 10.1016/j.juro.2013.03.072. Epub 2013 Mar 26.

  PMID: 23538237 BACKGROUND

• Xu A, Li B, Li H, Zheng S, Du W, Xu Y, Zou Y, Luo Q, Liu C. Comparison of seromuscular tunnel and split-cuff nipple antireflux ureteroenteral anastomosis techniques in orthotopic taenia myectomy sigmoid neobladder: a prospective, randomized study. Urology. 2013 Mar;81(3):669-74. doi: 10.1016/j.urology.2012.11.018. Epub 2013 Jan 3.

  PMID: 23290142 BACKGROUND

• Skinner EC, Fairey AS, Groshen S, Daneshmand S, Cai J, Miranda G, Skinner DG. Randomized Trial of Studer Pouch versus T-Pouch Orthotopic Ileal Neobladder in Patients with Bladder Cancer. J Urol. 2015 Aug;194(2):433-9. doi: 10.1016/j.juro.2015.03.101. Epub 2015 Mar 28.

  PMID: 25823791 BACKGROUND

• Bacchetti P, Leung JM. Sample size calculations in clinical research. Anesthesiology. 2002 Oct;97(4):1028-9; author reply 1029-32. doi: 10.1097/00000542-200210000-00050. No abstract available.

  PMID: 12357184 BACKGROUND

• Julious SA. Sample sizes for clinical trials with normal data. Stat Med. 2004 Jun 30;23(12):1921-86. doi: 10.1002/sim.1783.

  PMID: 15195324 BACKGROUND

• Miyake H, Furukawa J, Sakai I, Muramaki M, Yamashita M, Inoue TA, Fujisawa M. Orthotopic sigmoid vs. ileal neobladders in Japanese patients: a comparative assessment of complications, functional outcomes, and quality of life. Urol Oncol. 2013 Oct;31(7):1155-60. doi: 10.1016/j.urolonc.2011.11.015. Epub 2011 Dec 6.

  PMID: 22153716 BACKGROUND

• Clavien PA, Barkun J, de Oliveira ML, Vauthey JN, Dindo D, Schulick RD, de Santibanes E, Pekolj J, Slankamenac K, Bassi C, Graf R, Vonlanthen R, Padbury R, Cameron JL, Makuuchi M. The Clavien-Dindo classification of surgical complications: five-year experience. Ann Surg. 2009 Aug;250(2):187-96. doi: 10.1097/SLA.0b013e3181b13ca2.

  PMID: 19638912 BACKGROUND

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Abai Xu, doctor

  Zhujiang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Abai Xu, doctor

CONTACT

+86 18665626790; lc96xab@163.com

Peng Xu, doctor

CONTACT

+86 18665073650; yihuixp88@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief

Model Details: Superiority verification based on the ileal neobladder

Study Record Dates

• First Submitted: April 5, 2017
• First Posted: April 11, 2017
• Study Start: May 2, 2018
• Primary Completion: August 30, 2025
• Study Completion: September 30, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)