UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluarion of the usefulness of indocyanine green fluorescence imaging in pancreatic surgery.
Title of the study (Brief title)	Fluorescence imaging for pancreatic surgery.
Region	Japan

Condition
Condition	pancreatic cancer, cystic tumor in pancreas, neuroendocrine tumor, intrapapillary mucinous neoplasm, Solid pseudopapillary neoplasm
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the efficacy of indocyanine green fluorescence imaging for pancreatic surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Primary outcome is to assess fluorescence pattern of pancreatic lesion.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	85 years-old >=
Gender	Male and Female
Key inclusion criteria	Objictives:pancreatic cancer, pancreatic neuroendocrine tumor, intrapapillaly mucinous neoplasm, solid pseudopapillaly neoplasm 1)patient 20 years old or older. 2)patient who receive enough explanation, understand enough, and can agree with the study of their own accord.
Key exclusion criteria	1)there is an allergy carrer for indocyanine green. 2)there is an allergy carrer for iodine . 3)The patient who is judged to be inappropriate from medical grounds.
Target sample size	50

Research contact person
Name of lead principal investigator	Norihiro Kokudo
Organization	Graduate School of Medicine, University of Tokyo
Division name	Hepato-Biliary-Pancreatic Surgery Division
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL	+81338155411
Email	KOKUDO-2SU@h.u-tokyo.ac.jp

Public contact
Name of contact person	Chikara Shirata
Organization	Graduate School of Medicine, University of Tokyo
Division name	Hepato-Biliary-Pancreatic Surgery Division
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL	+81338155411
Homepage URL
Email	shiratac-tky@umin.ac.jp

Sponsor
Institute	University of Tokyo
Institute
Department

Funding Source
Organization	University of Tokyo
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 06 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 01 Month 05 Day
Anticipated trial start date	2016 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2018 Year 11 Month 01 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	We evaluated the usefulness of fluorescence imaging using indocyanine green to identify pancreas tumors in 23 patients undergoing pancreas resection. This technique was useful in visualizing pancreas lesions during surgery, specifically, neuroendocrine tumors as fluorescence and cystic neoplasms as a fluorescence defect.
Other related information	not applicable

Management information
Registered date	2017 Year 06 Month 20 Day
Last modified on	2018 Year 12 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027619