UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024705 |
|---|---|
| Receipt number | 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 21:31:01 |
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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
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
itoudaisuke5995@yahoo.co.jp
Sponsor or person
Institute
Cleveland Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028424
