Recurrent Bladder CancerNCT02252393
Urinary Diversion During Robotic Assisted Radical Cystectomy in Patients With Bladder Cancer
A study testing robot-assisted laparoscopic surgery, intraoperative complication management/prevention and quality-of-life assessment in people with Recurrent Bladder Cancer and Stage 0 Bladder Cancer, run by Case Comprehensive Cancer Center.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent Bladder Cancer, Stage 0 Bladder Cancer, Stage I Bladder Cancer
- What is being tested?
- robot-assisted laparoscopic surgery, intraoperative complication management/prevention and quality-of-life assessment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2015to Nov 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Grade G1 - G3 bladder cancer
- T stage: cTis - T2
- N0
- M0
- American Society of Anesthesiologists (ASA) < 4
- Informed consent
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- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
Official title: Prospective Randomized Comparison of Intracorporeal Versus Extracorporeal Urinary Diversion During Robotic Radical Cystectomy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Recurrent Bladder Cancer, Stage 0 Bladder Cancer, Stage I Bladder Cancer, Stage II Bladder Cancer, Urinary Complications
- Being tested
- robot-assisted laparoscopic surgery, intraoperative complication management/prevention, quality-of-life assessment
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
robot-assisted laparoscopic surgeryProcedure or surgery
Undergo RARC with IUD
robot-assisted laparoscopic surgeryProcedure or surgery
Undergo RARC with EUD
intraoperative complication management/preventionOther
Undergo RARC with IUD
intraoperative complication management/preventionOther
Undergo RARC with EUD
quality-of-life assessmentOther
Also called quality of life assessment
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (RARC with IUD) | Experimental | Patients undergo RARC with IUD. Receives: Procedure: robot-assisted laparoscopic surgery; Other: intraoperative complication management/prevention; Other: quality-of-life assessment |
| Arm II (RARC with EUD) | Experimental | Patients undergo RARC with EUD. Receives: Procedure: robot-assisted laparoscopic surgery; Other: intraoperative complication management/prevention; Other: quality-of-life assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days after surgery
Secondary outcomes (12)
Time to passage of flatus
Analyzed using regression analysis.
Measured: Up to 90 days
Analgesic requirement (narcotic use)
Analyzed using logistical regression.
Measured: Up to 90 days
Hospital length of stay
Analyzed using regression analysis.
Measured: Up to 90 days
Total operating time
Analyzed using regression analysis.
Measured: Up to completion of surgery
Estimated blood loss
Analyzed using regression analysis.
Measured: Up to 90 days
Readmission rate
Analyzed using regression analysis.
Measured: Up to 90 days
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
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.
Measured: Up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2014 (estimated)
- Study startOct 2015
- Primary completionNov 2016
- Study completionNov 2016
Why it stopped: waiting on surgeon training
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Bladder CancerStudies of the same condition, open and under way.
- More trials run by Case Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jihad Kaouk, Principal investigator, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02252393
- Sponsor's protocol ID
- CASE7814
- Other IDs
- NCI-2014-01530, CASE 7814, P30CA043703
- Status last verified
- Nov 2016
- First submitted
- 26 Sep 2014
- Last updated
- 9 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Comparison of Intracorporeal Versus Extracorporeal Urinary Diversion During Robotic Radical Cystectomy
- ClinicalTrials.gov ID
- NCT02252393
- Acronym / sponsor ID
- CASE7814
- Conditions
- Recurrent Bladder Cancer, Stage 0 Bladder Cancer, Stage I Bladder Cancer, Stage II Bladder Cancer, Urinary Complications
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: waiting on surgeon training
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Oct 2015
- Primary completion
- Nov 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 30 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (RARC with IUD) | Experimental | Procedure: robot-assisted laparoscopic surgery, Other: intraoperative complication management/prevention, Other: quality-of-life assessmentPatients undergo RARC with IUD. |
| Arm II (RARC with EUD) | Experimental | Procedure: robot-assisted laparoscopic surgery, Other: intraoperative complication management/prevention, Other: quality-of-life assessmentPatients undergo RARC with EUD. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Grade G1 - G3 bladder cancer
- T stage: cTis - T2
- N0
- M0
- American Society of Anesthesiologists (ASA) < 4
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| robot-assisted laparoscopic surgeryUndergo RARC with IUD | Procedure or surgery | Arm I (RARC with IUD) |
| robot-assisted laparoscopic surgeryUndergo RARC with EUD | Procedure or surgery | Arm II (RARC with EUD) |
| intraoperative complication management/preventionUndergo RARC with IUD | Other | Arm I (RARC with IUD) |
| intraoperative complication management/preventionUndergo RARC with EUD | Other | Arm II (RARC with EUD) |
| quality-of-life assessmentAlso: quality of life assessmentAncillary studies | Other | Arm I (RARC with IUD), Arm II (RARC with EUD) |
Primary outcome
Complication rate
Time frame: 90 days after surgery
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.
12 secondary outcomes
Time to passage of flatus
Time frame: Up to 90 days
Analgesic requirement (narcotic use)
Time frame: Up to 90 days
Hospital length of stay
Time frame: Up to 90 days
Total operating time
Time frame: Up to completion of surgery
Estimated blood loss
Time frame: Up to 90 days
Readmission rate
Time frame: Up to 90 days
Quality of life assessed using the Bladder Cancer Index Questionnaire
Time frame: Up to 5 years
Ureteral strictures
Time frame: Up to 5 years
Stromal stenosis
Time frame: Up to 5 years
Disease recurrence
Time frame: Up to 5 years
Secondary procedures
Time frame: Up to 5 years
Cumulative complication incidence
Time frame: Up to 5 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jihad Kaouk principal investigator
Case Comprehensive Cancer Center
Questions about this trial
What is this clinical trial studying?
A study testing robot-assisted laparoscopic surgery, intraoperative complication management/prevention and quality-of-life assessment in people with Recurrent Bladder Cancer and Stage 0 Bladder Cancer, run by Case Comprehensive Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 9 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complication rate (time frame: 90 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2016.