UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031504 |
|---|---|
| Receipt number | R000035962 |
| Scientific Title | Indocyanine green fluorescence imaging for assessing risk factors of anastomotic leakage after colorectal cancer surgery |
| Date of disclosure of the study information | 2018/02/27 |
| Last modified on | 2024/02/29 21:26:27 |
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Basic information
Public title
Indocyanine green fluorescence imaging for assessing risk factors of anastomotic leakage after colorectal cancer surgery
Acronym
ICG fluorescence imaging for assessing risk factor of anastomotic leakage of colorectal surgery
Scientific Title
Indocyanine green fluorescence imaging for assessing risk factors of anastomotic leakage after colorectal cancer surgery
Scientific Title:Acronym
ICG fluorescence imaging for assessing risk factor of anastomotic leakage of colorectal surgery
Region
| Japan |
Condition
Condition
Colorectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate indocyanine green fluorescence imaging being useful as an independent factor of anastomotic leakage by multivariate analysis
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Is it effective or not to assess blood flow at anastomotic site by indocyanine green fluorescent imaging?
Key secondary outcomes
To evaluate predictive value of ICG fluorescent imaging, tumor factors and/or intraoperative factors as a risk factor of anastomotic leakage
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
To assess the blood flow at anastomotic site by comparing a direct vision with that under near infrared light after intravenous infusion of indocyanine green.
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 who were diagnosed with left-sided or rectal cancer, and had operation with anastomosis
Key exclusion criteria
Patients who underwent Hartmann's procedure
Patients with a right-sided or Transverse colon cancer
Patients who underwent combined resection of other organs
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shuji |
| Middle name | |
| Last name | Takiguchi |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Gastroenterological Surgery
Zip code
467-8602
Address
1,Kawasumi,Mizuho-cho,Mizuho ward, Nagoya city,Aichi,Japan
TEL
052-853-8226
tyanagi@med.nagoya-cu.ac.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Yanagita |
Organization
Nagoya City University Graduate School of Medical Sciences
Division name
Gastroenterological Surgery
Zip code
4678602
Address
1,Kawasumi,Mizuho-cho,Mizuho ward, Nagoya city,Aichi,Japan
TEL
052-853-8226
Homepage URL
tyanagi@med.nagoya-cu.ac.jp
Sponsor or person
Institute
Nagoya City University Graduate School of Medical Sciences
Institute
Department
Personal name
Funding Source
Organization
Nagoya City University Graduate School of Medical Sciences
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
Nagoya City University Graduate School of Medical Sciences
Address
1 Kawasumi mizuho-cho, mizuho ward, Nagoya city, Aichi
Tel
052-853-8226
tyanagi@med.nagoya-cu.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
| 2018 | Year | 02 | Month | 27 | Day |
Related information
URL releasing protocol
https://link.springer.com/journal/464
Publication of results
Partially published
Result
URL related to results and publications
https://link.springer.com/journal/464
Number of participants that the trial has enrolled
415
Results
In this study setting, intraoperative ICG fuorescence imaging can dem- onstrate the possibility of reducing the incidence of AL after colorectal cancer surgery. In addition, assessment by NNT showed that ICG fuorescence imaging was efective for the prevention of postoperative AL.
Results date posted
| 2024 | Year | 02 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A single-center, prospective study was performed in 202 consecutive patients with left-sided colon or rectal cancer who underwent ICG fuorescence imaging during elective surgery from March 2015 to October 2018 (ICG group). In addition, the charts of 202 patients who had diagnoses and who underwent procedures similar to those of the ICG group from October 2011 to February 2015 were reviewed as a historical control group (HC group) for comparison.
Participant flow
Oral explanations and written informed consent were obtained from all individual participants included in the study.
Adverse events
No reported adverse event about infusion of ICG
Outcome measures
Postoperative anastomotic leakage rates
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 11 | Month | 16 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 02 | Month | 27 | Day |
Last modified on
| 2024 | Year | 02 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035962
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