UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018890 |
|---|---|
| Receipt number | R000021813 |
| Scientific Title | Indocyanine Green (ICG) fluorescence imaging for accurate intraoperative detection of early gastric cancer |
| Date of disclosure of the study information | 2016/01/01 |
| Last modified on | 2017/07/04 18:02:42 |
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Basic information
Public title
Indocyanine Green (ICG) fluorescence imaging for accurate intraoperative detection of early gastric cancer
Acronym
Indocyanine Green (ICG) fluorescence imaging for accurate intraoperative detection of early gastric cancer
Scientific Title
Indocyanine Green (ICG) fluorescence imaging for accurate intraoperative detection of early gastric cancer
Scientific Title:Acronym
Indocyanine Green (ICG) fluorescence imaging for accurate intraoperative detection of early gastric cancer
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate availability of ICG detection by near-infrared scopes on determination of the transection line during gastrectomy for early gastric cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Differences in length between preoperatively-determined and actual surgical margins
Key secondary outcomes
Detection rate of ICG during gastrectomy, size of visualized ICG, morbidity of preoperative upper endoscopy, prevalence of adverse effects of ICG injection, operative time, intraoperative estimated blood loss, pathological findings (e.g. tumor depth, proximal and distal margin), postoperative morbidity rate, frequency of additional resection
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
Diagnosis
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
ICG injection by near-infrared scopes
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
1) patients who are histologically proven gastric adenocarcinoma
2) patients who are diagnosed clinical T1 according to the 14th edition of Japanese Classification of Gastric Carcinoma
3) patients who receive informed consent
Key exclusion criteria
1) patients who have allergy to ICG
2) patients who have allergy to iodine
3) patients who are judged to be ineligible for subject by resercher
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuhiro Kodera |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aiti 466-8550, JAPAN
TEL
052-744-2249
ykodera@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Chie Tanaka |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Gastroenterological Surgery
Zip code
Address
65, Tsurumai-cho, Showa-ku, Nagoya, Aiti 466-8550, JAPAN
TEL
052-744-2250
Homepage URL
chtanaka@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterological Surgery, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nagoya Univerisity
Organization
Division
Category of Funding Organization
Self funding
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 | 01 | 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
Open public recruiting
Date of protocol fixation
| 2015 | Year | 12 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 01 | 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
prospective study
Management information
Registered date
| 2015 | Year | 09 | Month | 02 | Day |
Last modified on
| 2017 | Year | 07 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021813
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
