UMIN-CTR Clinical Trial

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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