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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000025900
Receipt No. 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

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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
Email 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
Email kobeps@med.kobe-u.ac.jp

Sponsor
Institute Division of Hepato-Biliary-Pancreatic Surgery, Department of Surgery, Kobe University Graduate School of Medicine
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029778

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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