UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Efficacy of Near Infrared Incisionless Fluorescent Cholangiography (NIFC) during Laparoscopic Cholecystectomy
Title of the study (Brief title)	Efficacy of Near Infrared Incisionless Fluorescent Cholangiography (NIFC) during Laparoscopic Cholecystectomy
Region	Japan North America

Condition
Condition	gallbladder stone chronic cholesistitis chlesistic polyp
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Demonstrate that NIFC performs better than standard white light (WLI) alone in visualizing and identifying extrahepatobiliary structures (Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction, and any Accessory Ducts) before and after dissection during Laparoscopic Cholecystectomy
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection Rate (DR) of each particular extra-hepatobiliary structure during Laparoscopic Cholecystectomy (LC) defined as the total number of patients in which the particular structure is detected before and after dissection in that arm of the Study (WLI or NIFC), divided by the total number of patients in that arm. Extra-hepatobiliary structures to be included in this assessment: Cystic Duct, Right Hepatic Duct, Common Hepatic Duct, Common Bile Duct, Cystic-CBD junction, Cystic-Gallbladder junction, and any Accessory Ducts
Key secondary outcomes	1. The DR for students/residents only (apart from experienced surgeons), both before and after dissection. 2. Time to Clip or Tie the Cystic Duct 3. Incidence Rate of Conversion to Open Surgery 4. Estimated Blood Loss 5. Incidence Rate of Bile Leakage 6. Incidence Rate of Bile Duct Injury (BDI) 7. Surgeon Confidence Level

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Medicine Device,equipment
Interventions/Control_1	Near Infrared Incisionless Fluorescent Cholangiography
Interventions/Control_2	Standard white light cholangiography
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	18 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Patients of both genders 2. Minimum age: 18 years old 3. Spoken and written command of the language spoken in the country's center 4. Ability to understand and follow the study procedures and sign the informed consent
Key exclusion criteria	1. Known allergies to iodides 2. Known history of coagulopathy 3. Known moderate or severe liver disease 4. Women who are pregnant or breastfeeding, or for whom possibility of pregnancy was not ruled out
Target sample size	1000

Research contact person
Name of lead principal investigator	Norihiro Kokudo
Organization	Graduate School of Medicine,University of Tokyo
Division name	Hepato-Pancreatico-Biliary Surgery Division,
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	+81-3-5800-8841
Email	KOKUDO-2SU@h.u-tokyo.ac.jp

Public contact
Name of contact person	Daisuke Ito
Organization	Graduate School of Medicine,University of Tokyo
Division name	Hepato-Pancreatico-Biliary Surgery Division
Address	7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL	+81-3-5800-8841
Homepage URL
Email	itoudaisuke5995@yahoo.co.jp

Sponsor
Institute	Cleveland Clinic
Institute
Department

Funding Source
Organization	Kurl strtz company
Organization
Division
Category of Funding Organization	Profit organization
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	2016 Year 12 Month 01 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 11 Month 01 Day
Anticipated trial start date	2016 Year 12 Month 01 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 11 Month 03 Day
Last modified on	2016 Year 11 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028424