Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer

Recurrent Bladder Cancer Clinical Trial

Official title:

Prospective Randomized Comparison of Intracorporeal Versus Extracorporeal Urinary Diversion During Robotic Radical Cystectomy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02252393
• Other study ID #: CASE7814
• Secondary ID: NCI-2014-01530CA
• Status: Withdrawn
• Phase: N/A
• First received: September 26, 2014
• Last updated: November 8, 2016
• Start date: October 2015
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

This randomized clinical trial studies intracorporeal or extracorporeal urinary diversion during robotic assisted radical cystectomy in reducing complications in patients with bladder cancer. Radical cystectomy is surgery to remove the entire bladder as well as nearby tissues and organs. After the bladder is removed, urinary diversion (a surgical procedure to make a new way for urine to leave the body) is performed. It is not yet known whether intracorporeal (within the body) or extracorporeal (outside of the body) urinary diversion is a better method in patients with bladder cancer undergoing robotic assisted radical cystectomy.

Description:

PRIMARY OBJECTIVES:

I. To compare perioperative outcomes and complications after robotic assisted radical cystectomy (RARC) with intracorporeal urinary diversion (IUD) and RARC with extracorporeal urinary diversion (EUD) in a prospective randomized fashion.

SECONDARY OBJECTIVES:

I. Time to passage of flatus. II. Analgesic requirement (narcotic use). III. Hospital length of stay. IV. Total operating time. V. Estimated blood loss. VI. Readmission rate. VII. Bladder Cancer Index Questionnaire. VIII. Ureteral strictures. IX. Stomal stenosis. X. Disease recurrence. XI. Secondary procedures.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo RARC with IUD.

ARM II: Patients undergo RARC with EUD.

After completion of study treatment, patients are followed up within 90 days and then for 2-5 years.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Grade G1 - G3 bladder cancer

• T stage: cTis - T2

• N0

• M0

• American Society of Anesthesiologists (ASA) < 4

• Informed consent

• Eastern Cooperative Oncology Group (ECOG) performance status 2 or better

• Hemoglobin (Hgb) > 8.0 g/dL

• White blood cell (WBC) > 2.0 k/uL

• Platelets > 50,000

• Creatinine < 3.0 x upper limit of normal (ULN)

• Aspartate aminotransferase (AST) < 5.0 x ULN

• Alanine transaminase (ALT) < 5.0 x ULN

Exclusion Criteria:

• Patient unsuitable for or refusing radical cystectomy

• T stage = T3 (mass extending outside the bladder)

• Gross nodal or metastatic disease at presentation (= N1, M1)

• Prior pelvic radiation

• Prior open or laparoscopic/robotic bladder or prostate surgery

• Prior colorectal surgery or history of inflammatory bowel disease

• Body mass index (BMI) = 40

• ECOG performance status 3 or worse

• History of coagulopathy or bleeding disorders

• Chronic steroid use

• Patients with end stage renal disease (ESRD) and/or on dialysis

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Recurrent Bladder Cancer
• Stage 0 Bladder Cancer
• Stage I Bladder Cancer
• Stage II Bladder Cancer
• Urinary Bladder Neoplasms
• Urinary Complications

Intervention

Procedure:
• robot-assisted laparoscopic surgery
Undergo RARC with IUD
• robot-assisted laparoscopic surgery
Undergo RARC with EUD

Other:
• intraoperative complication management/prevention
Undergo RARC with IUD
• intraoperative complication management/prevention
Undergo RARC with EUD
• quality-of-life assessment
Ancillary studies

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complication rate	Analyzed using multivariable logistical regression. Descriptions and grading scales found in the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 will be utilized for adverse event reporting.	90 days after surgery	Yes
Secondary	Time to passage of flatus	Analyzed using regression analysis.	Up to 90 days	No
Secondary	Analgesic requirement (narcotic use)	Analyzed using logistical regression.	Up to 90 days	No
Secondary	Hospital length of stay	Analyzed using regression analysis.	Up to 90 days	No
Secondary	Total operating time	Analyzed using regression analysis.	Up to completion of surgery	No
Secondary	Estimated blood loss	Analyzed using regression analysis.	Up to 90 days	No
Secondary	Readmission rate	Analyzed using regression analysis.	Up to 90 days	No
Secondary	Quality of life assessed using the Bladder Cancer Index Questionnaire	The Cox proportional hazards model will be used. The hazard ratio (HR) and 95% confidence interval (95% CI) associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.	Up to 5 years	No
Secondary	Ureteral strictures	The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.	Up to 5 years	No
Secondary	Stromal stenosis	The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.	Up to 5 years	No
Secondary	Disease recurrence	The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.	Up to 5 years	No
Secondary	Secondary procedures	The Cox proportional hazards model will be used. The HR and 95% CI associated with the use of RARC with IUD compared with the use of RARC with EUD will be calculated.	Up to 5 years	No
Secondary	Cumulative complication incidence	Graphically described using the Kaplan-Meier method. Descriptions and grading scales found in the NCI CTCAE version 4.0 will be utilized for adverse event reporting.	Up to 5 years	Yes