UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033827 |
|---|---|
| Receipt number | R000038533 |
| Scientific Title | Observation of lymphatic distribution by visualization of lymph flow of esophagogastric junction using ICG-PDD |
| Date of disclosure of the study information | 2018/09/25 |
| Last modified on | 2022/02/23 16:37:01 |
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Basic information
Public title
Observation of lymphatic distribution by visualization of lymph flow of esophagogastric junction using ICG-PDD
Acronym
Observation of lymphatic distribution of esophagogastric junction using ICG-PDD
Scientific Title
Observation of lymphatic distribution by visualization of lymph flow of esophagogastric junction using ICG-PDD
Scientific Title:Acronym
Observation of lymphatic distribution of esophagogastric junction using ICG-PDD
Region
| Japan |
Condition
Condition
Gastric cancer
Esophagogastric junction carcinoma
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We have been verifying anatomically and embryologically the infracardiac bursa (ICB) identified as a closed lumen between the esophagus and the right crus of the diaphragm during an operation, and we have been advocating the lymph node dissection using the ICB as a boundary. In this study, we aim to observe the lymphatic distribution around the esophagogastric junction by visualizing the lymph flow around the ICB by means of ICG-PDD.
Basic objectives2
Others
Basic objectives -Others
Anatomy
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Angle of lymph flow distribution to the maximum circumference of the infracardiac bursa. (average)
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Endoscopic submucosal injection 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We include cases undergoing laparoscopic total or proximal gastrectomy opening the ICB during the transhiatal lower mediastinal dissection.
Key exclusion criteria
We exclude cases where the esophagogastric junction is invaded by the tumor or cases a doctor considers inappropriate to participate in this study because of the patient or tumor condition.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Shinohara |
Organization
Hyogo College of Medicine
Division name
Department of Surgery, Upper G.I. Division
Zip code
663-8501
Address
1-1 Mukogawa-Cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6725
shinohara@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Yasunori |
| Middle name | |
| Last name | Kurahashi |
Organization
Hyogo College of Medicine
Division name
Department of Surgery, Upper G.I. Division
Zip code
663-8501
Address
1-1 Mukogawa-Cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL
0798-45-6725
Homepage URL
kurahashi@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo College of Medicine
Institute
Department
Personal name
Funding Source
Organization
No funding source
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
Hyogo College of Medicine
Address
1-1 Mukogawa-Cho, Nishinomiya, Hyogo 663-8501 JAPAN
Tel
0798-45-6725
kurahashi@hyo-med.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 | 09 | Month | 25 | 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 | 09 | Month | 25 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | 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 | 08 | Month | 20 | Day |
Last modified on
| 2022 | Year | 02 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038533
| 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 |
