UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017370 |
|---|---|
| Receipt number | R000020155 |
| Scientific Title | Sentinel lymph node and lymphatic flow mapping on HPB surgery |
| Date of disclosure of the study information | 2015/05/01 |
| Last modified on | 2019/02/14 12:20:29 |
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Basic information
Public title
Sentinel lymph node and lymphatic flow mapping on HPB surgery
Acronym
Sentinel mapping on HPB
Scientific Title
Sentinel lymph node and lymphatic flow mapping on HPB surgery
Scientific Title:Acronym
Sentinel mapping on HPB
Region
| Japan |
Condition
Condition
Hepato pancreatic biliary malignancies.
Classification by specialty
| 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 HPB surgery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1: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.
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
Localinjection 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 HPB disease
3. Require written informed concent.
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 | |
| Middle name | |
| Last name | Takehiro Noji |
Organization
Hokkaido University Graduate School of Medicine
Division name
Gastroenterological surgery II
Zip code
Address
Kita15 Nishi7, Kita-ku, Sapporo city, Japan
TEL
011-716-1161
drnoji@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takehiro Noji |
Organization
Hokkaido Univeristy Graduate School of Medicine
Division name
Gastroenterological Surgery II
Zip code
Address
Kita15 Nishi7, Kita-ku, Sapporo city, Japan
TEL
011-716-1161
Homepage URL
drnoji@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido Universtiy Graduate School of Medicine, Department of Gastroenterological SurgeryII
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
北海道大学病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
Completed
Date of protocol fixation
| 2015 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 20 | 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
| 2015 | Year | 05 | Month | 01 | Day |
Last modified on
| 2019 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020155
