UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Sentinel lymph node and lymphatic flow mapping on HPB surgery
Title of the study (Brief title)	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	Takehiro Noji
Organization	Hokkaido University Graduate School of Medicine
Division name	Gastroenterological surgery II
Address	Kita15 Nishi7, Kita-ku, Sapporo city, Japan
TEL	011-716-1161
Email	drnoji@med.hokudai.ac.jp

Public contact
Name of contact person	Takehiro Noji
Organization	Hokkaido Univeristy Graduate School of Medicine
Division name	Gastroenterological Surgery II
Address	Kita15 Nishi7, Kita-ku, Sapporo city, Japan
TEL	011-716-1161
Homepage URL
Email	drnoji@med.hokudai.ac.jp

Sponsor
Institute	Hokkaido Universtiy Graduate School of Medicine, Department of Gastroenterological SurgeryII
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 21 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020155