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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000033827
Receipt No. 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 2018/08/20

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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
Middle name
Last name Hisashi Shinohara
Organization Hyogo College of Medicine
Division name Department of Surgery, Upper G.I. Division
Zip code
Address 1-1 Mukogawa-Cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL 0798-45-6725
Email shinohara@hyo-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasunori Kurahashi
Organization Hyogo College of Medicine
Division name Department of Surgery, Upper G.I. Division
Zip code
Address 1-1 Mukogawa-Cho, Nishinomiya, Hyogo 663-8501 JAPAN
TEL 0798-45-6725
Homepage URL
Email kurahashi@hyo-med.ac.jp

Sponsor
Institute Hyogo College of Medicine
Institute
Department

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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2018 Year 09 Month 25 Day
Date of IRB
Anticipated trial start date
2018 Year 10 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

Management information
Registered date
2018 Year 08 Month 20 Day
Last modified on
2018 Year 08 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038533

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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