UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027276 |
|---|---|
| Receipt number | 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 | 2023/11/16 10:49:32 |
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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
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
saoono@city.fukuyama.hiroshima.jp
Sponsor or person
Institute
Fukuyama City Hospital
Institute
Department
Personal name
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
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
Terminated
Date of protocol fixation
| 2017 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 05 | Month | 10 | Day |
Last follow-up date
| 2018 | 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 | 05 | Month | 09 | Day |
Last modified on
| 2023 | Year | 11 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031253
