UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033342 |
|---|---|
| Receipt number | R000037981 |
| Scientific Title | Navigation surgery for gallbladder carcinoma using indocyanine-green (ICG) fluorescence |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2024/01/15 09:51:39 |
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Basic information
Public title
Navigation surgery for gallbladder carcinoma
using indocyanine-green (ICG) fluorescence
Acronym
Navigation surgery for gallbladder carcinoma
using ICG fluorescence
Scientific Title
Navigation surgery for gallbladder carcinoma
using indocyanine-green (ICG) fluorescence
Scientific Title:Acronym
Navigation surgery for gallbladder carcinoma
using ICG fluorescence
Region
| Japan |
Condition
Condition
gallbladder carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to evaluate feasibility of
visualization of the lymphatic pathway from
the gallbladder using intraoperative ICG
fluorescence imaging and clarify oncological
effectiveness and safety of navigation
surgery for gallbladder carcinoma based on
this imaging.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcomes were to identify the
extent of the lymphatic routes from the
gallbladder which was visualized by ICG
fluorescence imaging and clarify the absence
or presence of metastatic lesions inside and
outside this area in patients who underwent
navigation surgery using ICG fluorescence
imaging for gallbladder carcinoma.
Key secondary outcomes
The secondary outcomes were the absence or
presence of recurrence (the site of
recurrence), the rate of recurrence,
recurrence-free survival, and overall survival
in these patients.
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
| Maneuver |
Interventions/Control_1
A small volume (0.1-0.5 ml) of ICG (0.025
mg/ml) was injected into the lymphatic system
of the gallbladder. Fluorescence imaging was
obtained by infrared ray electronic endoscopy.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with clinically diagnosed gallbladder
carcinoma who underwent radical resection.
Key exclusion criteria
Patients who did not agree with participating
in this study.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toshifumi Wakai |
Organization
Niigata University Graduate School of Medical
and Dental Sciences
Division name
Division of Digestive and General Surgery
Zip code
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata 951-8510, Japan
TEL
025-227-2228
wakait@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Jun Sakata |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Digestive and General Surgery
Zip code
Address
1-757 Asahimachi-dori, Chuo-ku, Niigata City, Niigata 951-8510, Japan
TEL
025-227-2228
Homepage URL
jsakata2@med.niigata-u.ac.jp
Sponsor or person
Institute
Division of Digestive and General Surgery,
Niigata University Graduate School of Medical
and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Nothing
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
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
| 2023 | Year | 10 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037981
