UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003816 |
|---|---|
| Receipt number | R000004176 |
| Scientific Title | Indocyanine green fluorescent imaging of neurovascular bundle during laparoscopic rectal dissection |
| Date of disclosure of the study information | 2010/06/25 |
| Last modified on | 2010/06/24 12:20:49 |
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Basic information
Public title
Indocyanine green fluorescent imaging of neurovascular bundle during laparoscopic rectal dissection
Acronym
Indocyanine green fluorescent imaging of neurovascular bundle
Scientific Title
Indocyanine green fluorescent imaging of neurovascular bundle during laparoscopic rectal dissection
Scientific Title:Acronym
Indocyanine green fluorescent imaging of neurovascular bundle
Region
| Japan |
Condition
Condition
rectal cancer
Classification by specialty
| Gastrointestinal surgery | Operative medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of fluorescent imaging technique for the detection of neurovascular bundle during laparoscopic rectal dissection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
homologous comparison between fluorescent and laparoscopic images of neurovascular bundle
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Indocyanine green
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Patient with rectal cancer who is supposed to undergo laparoscopic surgery
2,Patient who gave prior informed consent
Key exclusion criteria
N/A
Target sample size
3
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshiharu Sakai |
Organization
Kyoto University
Division name
Department of Surgery
Zip code
Address
54 Shogoinkawaracho, Sakyo-ku, Kyoto, Kyoto
TEL
075-751-3220
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichiro Kawamura |
Organization
Kyoto University
Division name
Department of Surgery
Zip code
Address
54 Shogoinkawaracho, Sakyo-ku, Kyoto, Kyoto
TEL
075-751-3220
Homepage URL
kawamura@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Kyoto University
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
Address
Tel
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
| 2010 | Year | 06 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2010 | Year | 05 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 07 | 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
| 2010 | Year | 06 | Month | 24 | Day |
Last modified on
| 2010 | Year | 06 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004176
