UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030798 |
|---|---|
| Receipt number | R000035168 |
| Scientific Title | Evaluation of intestinal blood flow around the rectosigmoid junction using ICG fluorescence method for the patients with colorectal cancer |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2023/07/20 09:46:05 |
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Basic information
Public title
Evaluation of intestinal blood flow around the rectosigmoid junction using ICG fluorescence method for the patients with colorectal cancer
Acronym
Evaluation of intestinal blood flow around the rectosigmoid junction using ICG fluorescence method
Scientific Title
Evaluation of intestinal blood flow around the rectosigmoid junction using ICG fluorescence method for the patients with colorectal cancer
Scientific Title:Acronym
Evaluation of intestinal blood flow around the rectosigmoid junction using ICG fluorescence method
Region
| Japan |
Condition
Condition
colorectal cancer
Classification by specialty
| Surgery in general | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate intestinal blood flow around the rectosigmoid lesion before anastomosis during the surgery for the patients with colorectal cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
incidence rate of anastomotic leakage
Key secondary outcomes
1. incidence rate of side effect caused by ICG
2. evaluation of oral side intestinal blood flow
3. evaluation of anal side intestinal blood flow and distance from peritoneal reflection
4. evaluation of anastomotic blood flow after anastomosis
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
venous injection of Indocyanine green during the colorectal surgery
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients who will be performed surgeries for sigmoid or rectal cancer
2) Surgical methods including sigmoidectomy or anterior resection
3) Patients with performance status 0-2
4) Patients who are informed and consent
Key exclusion criteria
1) Allergic hypersensitivity to indocyanine green
2) Allergic hypersensitivity to iodine
3) Pregnant or parturient or lactating patients
4) Inappropriate patients judged by the investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Fumihiko |
| Middle name | |
| Last name | Fujita |
Organization
Kurume University
Division name
Department of Surgery
Zip code
830-0011
Address
67 Asahi-machi, Kurume city, 830-0011
TEL
0942-31-7566
ffujita@kurume-u.ac.jp
Public contact
Name of contact person
| 1st name | Fumihiko |
| Middle name | |
| Last name | Fujita |
Organization
Kurume University
Division name
Department of Surgery
Zip code
830-0011
Address
67 Asahi-machi, Kurume city, 830-0011
TEL
0942-31-7566
Homepage URL
ffujita@kurume-u.ac.jp
Sponsor or person
Institute
Kurume University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Kurume University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
None
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Kurume University
Address
67 Asahi-machi, Kurume city, 830-0011
Tel
0942-65-3749
i_rinri@kurume-u.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
久留米大学病院（福岡県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 15 | 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
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 18 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 14 | Day |
Last modified on
| 2023 | Year | 07 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035168
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
