UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051106 |
|---|---|
| Receipt number | R000058280 |
| Scientific Title | Study of changes in residual gastric motility function after gastrectomy using gastric scintigraphy |
| Date of disclosure of the study information | 2023/05/22 |
| Last modified on | 2023/05/19 13:44:55 |
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Basic information
Public title
Study of changes in residual gastric motility after gastrectomy
Acronym
Evaluation of residual gastric motility after gastrectomy using gastric scintigraphy
Scientific Title
Study of changes in residual gastric motility function after gastrectomy using gastric scintigraphy
Scientific Title:Acronym
Evaluation of residual gastric motility after gastrectomy using gastric scintigraphy
Region
| Japan |
Condition
Condition
Gastric cancer, esophagogastric junction cancer, esophageal cancer, morbidly obesity disease
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To objectively examine gastric motility after gastrectomy using gastric scintigraphy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
As gastric emptying capacity, changes in whole stomach radioactivity counts at 30, 60, and 90 minutes after ingestion of the test meal are evaluated for each procedure.
Key secondary outcomes
(1) To compare radiation counts expelled from the stomach in the upright and supine positions.
(2) To compare changes in residual gastric motility function by surgical technique.
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
gastric scintigraphy
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who underwent gastrectomy at Hyogo Medical University Hospital
Key exclusion criteria
1 Patients with a history of surgery for intestinal obstruction.
2 Patients with peritoneal dissemination.
3 Patients with neurological diseases such as Parkinson's disease or metabolic diseases such as
diabetes mellitus with neuropathy .
4 Patients using the following drugs. Prostaglandins, antidepressants, anxiolytics, and antipsychotics.
However, patients who are able to discontinue these medications for approximately two weeks prior to
the start of the study may participate in the study.
5 Pregnant women, lactating women, or patients who wish to become pregnant during the period
of participation in this study.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Shinohara |
Organization
Hyogo Medical University
Division name
Department of Gastroenterological Surgery, Division of Upper G.I.
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
+81-798-45-6725
shinohara@hyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuro |
| Middle name | |
| Last name | Nakamura |
Organization
Hyogo Medical University
Division name
Department of Gastroenterological Surgery, Division of Upper G.I.
Zip code
663-8501
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
TEL
+81-798-45-6725
Homepage URL
tnakamura@hyo-med.ac.jp
Sponsor or person
Institute
Hyogo Medical University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Nihon Medi-Physics Co.,Ltd.
IRB Contact (For public release)
Organization
Ethics Review Committee, Hyogo Medical University
Address
1-1 Mukogawa-cho, Nishinomiya, Hyogo, Japan
Tel
+81-798-45-6066
rinri@hyo-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
| 2023 | Year | 05 | Month | 22 | 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
| 2022 | Year | 05 | Month | 23 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 23 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 23 | Day |
Last follow-up date
| 2027 | 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
| 2023 | Year | 05 | Month | 19 | Day |
Last modified on
| 2023 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058280
