UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061699 |
|---|---|
| Receipt number | R000070602 |
| Scientific Title | A Single-Center Prospective Exploratory Study Evaluating the Safety and Feasibility of Fluorescence-Guided Biliary Navigation by Direct Intrabiliary or Intracholecystic Injection of Indocyanine Green |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/05/26 23:15:43 |
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Basic information
Public title
A Prospective Study Evaluating the Safety and Utility of ICG Fluorescence-Guided Biliary Navigation Surgery
Acronym
ICG-Biliary Navigation Study
Scientific Title
A Single-Center Prospective Exploratory Study Evaluating the Safety and Feasibility of Fluorescence-Guided Biliary Navigation by Direct Intrabiliary or Intracholecystic Injection of Indocyanine Green
Scientific Title:Acronym
DIRECT-ICG study
Region
| Japan |
Condition
Condition
Biliary diseases and hepatobiliary-pancreatic tumors requiring hepatobiliary surgery
Classification by specialty
| Hepato-biliary-pancreatic surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to prospectively evaluate the safety and feasibility of fluorescence-guided biliary navigation using direct intrabiliary or intracholecystic injection of indocyanine green (ICG). In particular, this study aims to assess the utility of this technique for intraoperative visualization of biliary anatomy, identification of bile leakage sites, and surgical navigation during hepatobiliary procedures.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Incidence of adverse events related to direct intrabiliary or intracholecystic injection of indocyanine green
2. Successful intraoperative biliary visualization rate
3. Visibility assessment of biliary anatomy during fluorescence navigation
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Diluted indocyanine green (ICG) solution will be directly injected into the bile duct or gallbladder during surgery, followed by near-infrared fluorescence imaging for biliary visualization. Injection will be performed through an ENBD tube, gallbladder puncture, or biliary tube as appropriate.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients scheduled to undergo hepatobiliary surgery at International University of Health and Welfare Narita Hospital
2. Cases considered suitable for intraoperative biliary navigation
3. Patients who provide written informed consent after receiving sufficient explanation regarding the study
Key exclusion criteria
1. Patients with a history of hypersensitivity to ICG or iodine
2. Pregnant patients or patients with possible pregnancy
3. Patients with severe hepatic dysfunction or poor general condition
4. Patients deemed unsuitable for study participation by the principal investigator
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Osamu |
| Middle name | |
| Last name | Itano |
Organization
International University of Health and Welfare Narita Hospital
Division name
Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
Zip code
2860124
Address
852, Hatakeda, Narita, Chiba
TEL
0476-35-5600
itano@ihwg.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Minagawa |
Organization
International University of Health and Welfare Narita Hospital
Division name
Department of Hepato-Biliary-Pancreatic and Gastrointestinal Surgery
Zip code
2860124
Address
852, Hatakeda, Narita, Chiba
TEL
0476-35-5600
Homepage URL
tminagawa@ihwg.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
Organization name: Departmental Research Fund, Department of Gastrointestinal Surgery, International University of Health and Welfare Narita Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare Chiba District Ethics Review Committee
Address
852, Hatakeda, Narita, Chiba
Tel
0476-35-5600
rinri_md@iuhw.ac.jp
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
| 2026 | Year | 07 | 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
| 2026 | Year | 05 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 26 | Day |
Last modified on
| 2026 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070602
