UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028469 |
|---|---|
| Receipt number | 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 15:48:34 |
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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
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
sh2-miya@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University, Satiama Medical Center
Department of Urology
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032591
