UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025900 |
|---|---|
| Receipt number | R000029778 |
| Scientific Title | Intraoperative near-infrared fluorescence imaging using indocyanine green during staging laparoscopy for detecting small metastasis in pancreatic cancer: A prospective study |
| Date of disclosure of the study information | 2017/04/01 |
| Last modified on | 2020/02/26 15:08:38 |
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Basic information
Public title
Intraoperative near-infrared fluorescence imaging using indocyanine green during staging laparoscopy for detecting small metastasis in pancreatic cancer: A prospective study
Acronym
NIR fluorescence imaging during staging laparoscopy for detecting metastases in pancreatic cancer
Scientific Title
Intraoperative near-infrared fluorescence imaging using indocyanine green during staging laparoscopy for detecting small metastasis in pancreatic cancer: A prospective study
Scientific Title:Acronym
NIR fluorescence imaging during staging laparoscopy for detecting metastases in pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To determine usefulness of NIR fluorescence imaging of the liver for detecting small metastasis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Detecting rate of small liver metastases
Key secondary outcomes
Rate of avoiding unnecessary laparotomy by NIR fluorescence imaging
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Near-infrared fluorescence imaging
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
Patients who are scheduled for staging laparoscopy before curative surgery
Patients who can make his/her own decision to resister
Key exclusion criteria
Allergy to iodine
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Kido |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6302
kidkid@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masahiro Kido |
Organization
Kobe University Graduate School of Medicine
Division name
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery
Zip code
Address
7-5-2 Kusunoki-cho, Chuo-ku, Kobe, Hyogo, Japan
TEL
078-382-6302
Homepage URL
kobeps@med.kobe-u.ac.jp
Sponsor or person
Institute
Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kobe University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
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
神戸大学病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 03 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 30 | Day |
Last modified on
| 2020 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029778
