UMIN-CTR Clinical Trial

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

gallbladder stone
chronic cholesistitis
chlesistic polyp

Classification by specialty

Hepato-biliary-pancreatic surgery

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

Cleveland Clinic

Institute

Department

Personal name

Organization

Kurl strtz company

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related 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