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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027276
Receipt No. R000031253
Scientific Title Preoperative assessment of vascular anatomy by the chest and abdominal computed tomography (CT) angiography using nitroglycerin.
Date of disclosure of the study information 2017/05/10
Last modified on 2017/11/09

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Basic information
Public title Preoperative assessment of vascular anatomy by the chest and abdominal computed tomography (CT) angiography using nitroglycerin.
Acronym Preoperative assessment of vascular anatomy by the chest and abdominal computed tomography (CT) angiography using nitroglycerin.
Scientific Title Preoperative assessment of vascular anatomy by the chest and abdominal computed tomography (CT) angiography using nitroglycerin.
Scientific Title:Acronym Preoperative assessment of vascular anatomy by the chest and abdominal computed tomography (CT) angiography using nitroglycerin.
Region
Japan

Condition
Condition Preoperative patients with chest and abdominal malignant diseases.
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the clinical efficacy of nitroglycerin on chest and abdominal CT angiography.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Visual evaluation.
Comparison of vessel diameters (inferior pancreaticoduodenal artery, middle colic artery, anterior ascending branch and right gastric artery).
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 Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 <Patient>
Preoperative patients with chest and abdominal malignant diseases are included in this study. Inclusion criteria or exclusion criteria are as follows.
After we confirm that the patient meets the criteria, we explain the examination to the patient and obtain the informed consent.
<Materials and methods>
The chest and abdominal CT angiography with nitroglycerin is carried out as a preoperative examination. Within 5 minutes after the patient takes 1 tablet of nitroglycerin(0.3mg), CT scan with intravenous contrast is performed. We define those images as the target images. About 3 months after surgery for malignant disease in the chest and abdomen, we perform the chest and abdominal CT angiography without nitroglycerin as follow up in the same patient. We define those images as the control images.
<Assessment>
We compare vessel diameters of the inferior pancreaticoduodenal artery, middle colic artery, anterior ascending branch and right gastric artery between on the target and the control images. The abdominal vessels are compared in patients who undergo chest surgery, and the chest vessels are compared in patients who undergo abdominal surgery. In cases we cannot undergo surgery, both the chest and abdominal vessels are compared.
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Preoperative cases of chest and abdominal malignant diseases.
Key exclusion criteria We excluded patients with characteristics unsuitable, including contraindication to nitroglycerin, allergy to iodine contrast,severe hypotension, advanced bradycardia, acute phase of myocardial infarction, primary pulmonary hypertension, severe asthma, serum creatinine level greater than 1.5 mg/dL with or without hemodialysis, head injury or cerebral hemorrhage, closed angle glaucoma, pregnant state, and inability to adhere to the study procedures.
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Oono
Organization Fukuyama City Hospital
Division name Surgery
Zip code
Address 5-23-1 Zao-machi, Fukuyama city, Hiroshima prefecture
TEL 084-941-5151
Email saoono@city.fukuyama.hiroshima.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Oono
Organization Fukuyama City Hospital
Division name Surgery
Zip code
Address 5-23-1 Zao-machi, Fukuyama city, Hiroshima prefecture
TEL 084-941-5151
Homepage URL
Email saoono@city.fukuyama.hiroshima.jp

Sponsor
Institute Fukuyama City Hospital
Institute
Department

Funding Source
Organization Fukuyama City Hospital
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
2017 Year 05 Month 10 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 01 Day
Date of IRB
Anticipated trial start date
2017 Year 05 Month 10 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
2017 Year 05 Month 09 Day
Last modified on
2017 Year 11 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031253

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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