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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027898
Receipt No. R000031966
Scientific Title The evaluation of blood flow in the liver/intestine and the hepatic/mesenteric artery in pancreatectomy combined with major arterial resection/reconstruction using indocyanine green angiography
Date of disclosure of the study information 2017/07/01
Last modified on 2019/05/30

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Basic information
Public title The evaluation of blood flow in the liver/intestine and the hepatic/mesenteric artery in pancreatectomy combined with major arterial resection/reconstruction using indocyanine green angiography
Acronym The evaluation of blood flow in the liver/intestine and the hepatic/mesenteric artery in pancreatectomy combined with major arterial resection/reconstruction
Scientific Title The evaluation of blood flow in the liver/intestine and the hepatic/mesenteric artery in pancreatectomy combined with major arterial resection/reconstruction using indocyanine green angiography
Scientific Title:Acronym The evaluation of blood flow in the liver/intestine and the hepatic/mesenteric artery in pancreatectomy combined with major arterial resection/reconstruction
Region
Japan

Condition
Condition Pancreatic cancer with arterial invasion
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 evaluation of blood flow in the liver/intestine and the hepatic/mesenteric artery in pancreatectomy combined with major arterial resection/reconstruction using indocyanine green angiography
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes evaluation of blood flow in the liver/intestine and the hepatic/mesenteric artery, frequency of hepatic infarction or mesenteric ischemia
Key secondary outcomes frequency of the postoperative complication

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
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 We observe the indocianine green fluoroscence flow of reconstructed aetery and hepatic/intestine after i.v. of indocianine green 2.5mg/1ml
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1) Patients undergone pancreatectomy with artery reconstruction
2) Patients with the consent of the document has been obtained from the person himself/herself to become the subject of this examination
Key exclusion criteria 1) Patient with iodinated contrast agent allergy
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Yamaue
Organization Wakayama Medical University, School of Medicine
Division name Second Department od Surgery
Zip code 641-8510
Address Kimiidera 811-1, Wakayama, Japan
TEL 0734410613
Email yamaue-h@wakayama-med.ac.jp

Public contact
Name of contact person
1st name Kenichi
Middle name
Last name Okada
Organization Wakayama Medical University, School of Medicine
Division name Second Department od Surgery
Zip code 641-8510
Address Kimiidera 811-1, Wakayama, Japan
TEL 0734410613
Homepage URL
Email okada@wakayama-med.ac.jp

Sponsor
Institute Second Department od Surgery, Wakayama Medical University, School of Medicine
Institute
Department

Funding Source
Organization Second Department od Surgery, Wakayama Medical University, School of Medicine
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 Wakayama Medical University
Address Kimiidera, 811-1, Wakayama City, Wakayama
Tel 0734410714
Email okada@wakayama-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
2017 Year 07 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
2017 Year 05 Month 30 Day
Date of IRB
2017 Year 05 Month 30 Day
Anticipated trial start date
2017 Year 05 Month 30 Day
Last follow-up date
2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 06 Month 23 Day
Last modified on
2019 Year 05 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031966

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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