UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011098 |
|---|---|
| Receipt number | R000012966 |
| Scientific Title | Correlation between MRI-assessed gastric motility and gastric emptying scintigraphy in patients after lung transplantation |
| Date of disclosure of the study information | 2013/08/31 |
| Last modified on | 2015/07/27 19:28:15 |
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Basic information
Public title
Correlation between MRI-assessed gastric motility and gastric emptying scintigraphy in patients after lung transplantation
Acronym
Correlation between MRI-assessed gastric motility and gastric emptying scintigraphy in patients after lung transplantation
Scientific Title
Correlation between MRI-assessed gastric motility and gastric emptying scintigraphy in patients after lung transplantation
Scientific Title:Acronym
Correlation between MRI-assessed gastric motility and gastric emptying scintigraphy in patients after lung transplantation
Region
| Japan |
Condition
Condition
gastroparesis
Classification by specialty
| Gastroenterology | Chest surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate if assessment of gastric motlity by MRI can be used in place of gastric emptying scintighraphy for evaluation of gastroparesis after lung transplantation
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1.Parameters of gastric motility and percent retention obtained by MRI
2.Parameters obtained by gastric emptying scintigraphy
Key secondary outcomes
1. Amplitude, velocity, and frequency of antral contraction wave in stomach obtained by cine MRI.
2. Percent retention at twenty minutes obtained by MRI
3. Half-emptying time and percent retention at each time until 2 hours obtained by gastric emptying scintigraphy.
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 | Device,equipment |
Interventions/Control_1
Patients undergo gastric emptying scintigraphy in which images are obtained every 15 minutes until 2 hours after eating a pancake containing 99mTc-DTPA with 400ml of water.
Patients also undergo MRI study at prone position after eating a pancake with 400ml of water.
Patients fast for 8 hours before each study.
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
post-lung transplantation
Key exclusion criteria
1. Patients with a pacemaker
2. Patients with metallic devices
3. Poor general condition
4. Pregnant women
5. Allergy to ingredient of pancake (flour)
6. Patients after gastrectomy
7.Patients suffering from diseases which may cause gastroparesis, such as diabetes mellitus and scleroderma
8. Patients who taking drugs which inhibit gastric motility
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kaori Togashi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Diagnostic Radiology and Nuclear Medicine
Zip code
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Department of Diagnostic Radiology and Nuclear Medicine
Division name
Department of Diagnostic Radiology and Nuclear Medicine
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2013 | Year | 08 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 02 | Day |
Last modified on
| 2015 | Year | 07 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012966
