UMIN-CTR Clinical Trial

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028469
Receipt No. R000032591
Scientific Title clinical study of Robot-Assisted Radical Cystectomy for invasive bladder cancer
Date of disclosure of the study information 2017/08/01
Last modified on 2019/08/14 (Ver. 4)

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Basic information
Public title clinical study of Robot-Assisted Radical Cystectomy for invasive bladder cancer
Acronym RARC for bladder cancer
Scientific Title clinical study of Robot-Assisted Radical Cystectomy for invasive bladder cancer
Scientific Title:Acronym RARC for bladder cancer
Region
Japan

Condition
Condition invasive bladder cancer
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Consider the safety and efficacy for robot-assisted radical cystectomy using daVinci Si System.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intra and and postoperative complications and their contents
Key secondary outcomes operation time, duration for anesthesia, a, bleeding, postoperative use for pain medication, postoperative hospitalization period, histopathological findings

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Radical cystectomy performed with daVinci Si system,
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Invasive bladder cancer cT1-2N0M0
,who obtained written informed consent
Key exclusion criteria 1 The patient seems to be difficult for robot-assisted surgery due to previous surgery.
2. The patient with multiple cancers (cancer combined cancer and disease-free period within five years of different multiple cancer).
3. patients with impossible discontinuation of anticoagulants.
4. patients requiring blood transfusion due to anemia or bleeding.
5. morbid obesity (bimi35 or higher)
6. renal transplant history.
7. dialysis patients.
8. pregnant women or pregnant or lactating women
9. patients with a mental illness or psychiatric symptoms.
10. patients who is difficult for surgical treatment because of serious complications (angina pectoris, myocardial infarction, serious arrhythmias, uncontrolled diabetes, malignant hypertension, etc.
11. patients who have renal dysfunction (serum creatinine levels 1.5mg/dl or more), liver dysfunction (AST, ALT 100IU/l or more).
12. patients with bacterial infections requiring treatments.
13. patients with interstitial pneumonitis and pulmonary fibrosis.
14. patients with severe drug hypersensitivity, drug allergies.
15. minors
16. patients seemed unfit for other reasons.
Target sample size 3

Research contact person
Name of lead principal investigator
1st name Tomoaki
Middle name
Last name Miyagawa
Organization Jichi Medical University, Satiama Medical Center
Division name Department of Urology
Zip code 330-8503
Address 1-847 Amanuma-cho, Omiya-ku, Saitama city, Saitama, Japan
TEL 048-647-2111
Email sh2-miya@jichi.ac.jp

Public contact
Name of contact person
1st name Tomoaki
Middle name
Last name Miyagawa
Organization Jichi Medical University, Satiama Medical Center
Division name Department of Urology
Zip code 3308503
Address 1-847 Amanuma-cho, Omiya-ku, Saitama city, Saitama, Japan
TEL 048-647-2111
Homepage URL
Email sh2-miya@jichi.ac.jp

Sponsor
Institute Jichi Medical University, Satiama Medical Center
Department of Urology
Institute
Department

Funding Source
Organization Jichi Medical University, Satiama Medical Center
Department of Urology
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Jichi Medical University, Satiama Medical Center
Address 1-847 Amanuma-cho, Omiya-ku, Saitama city, Saitama, Japan
Tel 048-647-2111
Email sh2-miya@jichi.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled 3
Results 
All three patients were male
Age 64-77
Invasive bladder cancer
Urinary diversion is 2 cases of ileal conduit, 1 case of cutaneostomy
Surgery time 363-507 minutes
Console time 215-267 minutes
Blood loss 60-500ml
No postoperative complications
Discharged 10-14 days after surgery.
Results date posted
2019 Year 08 Month 14 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2019 Year 02 Month 07 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2017 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 07 Month 31 Day
Last modified on
2019 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032591