UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019275 |
|---|---|
| Receipt number | R000021807 |
| Scientific Title | Sentinel lymph node and lymphatic flow mapping on digestive surgery |
| Date of disclosure of the study information | 2015/10/20 |
| Last modified on | 2019/04/12 18:25:56 |
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Basic information
Public title
Sentinel lymph node and lymphatic flow mapping on digestive surgery
Acronym
Sentinel mapping on digestive surgery
Scientific Title
Sentinel lymph node and lymphatic flow mapping on digestive surgery
Scientific Title:Acronym
Sentinel mapping on digestive surgery
Region
| Japan |
Condition
Condition
digestive malignancies
Classification by specialty
| Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is conducted to evaluate
whether invisible yet tissue-penetrating near-infrared (NIR) fluorescent light can provide simultaneous identification of both the sentinel lymph node (SLN) and all other regional lymph nodes (RLN) on digestive surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
we exploit invisible near-infrared (NIR) fluorescent light and leverage novel chemical entities and imaging systems, to explore sentinel lymph node and route of lymphatic flow mapping. We examine the false-negative rate.
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
Local injection of 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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient's age over 20 years old
2. Patients with digestive malignant disease
3. Require written informed consent
Key exclusion criteria
1. Patients with allergy for indocyanine green or iodine.
2. Investigator could exclude insufficient patients for this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuma |
| Middle name | |
| Last name | Ebihara |
Organization
Hokkaido University Graduate School of Medicine
Division name
Gastroenterological surgery II
Zip code
0608638
Address
Kita15 Nishi7, Kita-ku, Sapporo city, Japan
TEL
011-716-1161
yuma-ebi@wc4.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Yuma |
| Middle name | |
| Last name | Ebihara |
Organization
Hokkaido University Graduate School of Medicine
Division name
Gastroenterological surgery II
Zip code
0608638
Address
Kita15 Nishi7, Kita-ku, Sapporo city, Japan
TEL
011-716-1161
Homepage URL
yuma-ebi@wc4.so-net.ne.jp
Sponsor or person
Institute
Hokkaido Universtiy Graduate School of Medicine, Department of Gastroenterological SurgeryII
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Graduate School of Medicine
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
Hokkaido University Hospital Division of Clinical Research Administration
Address
Kita-ku North 14 West 5, Sapporo
Tel
011-701-7636
crjimu@huhp.hokudai.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
| 2015 | Year | 10 | Month | 20 | 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
7
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
Completed
Date of protocol fixation
| 2015 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2015 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2015 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 08 | Day |
Last modified on
| 2019 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021807
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
