UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Recruitment status Completed
Unique ID issued by UMIN UMIN000011098
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email

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
Email

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012966


Contact us.