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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000024705
Receipt No. R000028424
Scientific Title Efficacy of Near Infrared Incisionless Fluorescent Cholangiography (NIFC) during Laparoscopic Cholecystectomy
Date of disclosure of the study information 2016/12/01
Last modified on 2016/11/03

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Basic information
Public title Efficacy of Near Infrared Incisionless Fluorescent Cholangiography (NIFC) during Laparoscopic Cholecystectomy
Acronym Efficacy of Near Infrared Incisionless Fluorescent Cholangiography (NIFC) during Laparoscopic Cholecystectomy
Scientific Title Efficacy of Near Infrared Incisionless Fluorescent Cholangiography (NIFC) during Laparoscopic Cholecystectomy
Scientific Title:Acronym 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
1st name
Middle name
Last name Norihiro Kokudo
Organization Graduate School of Medicine,University of Tokyo
Division name Hepato-Pancreatico-Biliary Surgery Division,
Zip code
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
1st name
Middle name
Last name Daisuke Ito
Organization Graduate School of Medicine,University of Tokyo
Division name Hepato-Pancreatico-Biliary Surgery Division
Zip code
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)

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

Other administrative information
Date of disclosure of the study information
2016 Year 12 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 Preinitiation
Date of protocol fixation
2016 Year 11 Month 01 Day
Date of IRB
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

Other
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

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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