UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023204 |
|---|---|
| Receipt number | R000026749 |
| Scientific Title | Clinical study of motility of the stomach in the patients with gastric fistula; assessment of motility of the stomach measured by the pressure transducer from gastric fistula. |
| Date of disclosure of the study information | 2016/08/15 |
| Last modified on | 2025/03/18 17:50:12 |
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Basic information
Public title
Clinical study of motility of the stomach in the patients with gastric fistula;
assessment of motility of the stomach measured by the pressure transducer from gastric fistula.
Acronym
Clinical study of motility of the stomach in the patients with gastric fistula.
Scientific Title
Clinical study of motility of the stomach in the patients with gastric fistula;
assessment of motility of the stomach measured by the pressure transducer from gastric fistula.
Scientific Title:Acronym
Clinical study of motility of the stomach in the patients with gastric fistula.
Region
| Japan |
Condition
Condition
The patients with gastric fistula
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Assessment of motility of the stomach measured from gastric fistula.
The relationship between motility of the
stomach and survival rate is going to be
estimated.
Motility of the stomach measured from
gastric fistula is going to be compared
with the data of electrogastrography
Basic objectives2
Others
Basic objectives -Others
The relationship age, nutritional status, liver function, kidney function, and
presence or absence of diabetes mellitus
and survival rate is going to be
estimated. .
Comparison with motility of the stomach
measured and the data of
electrogastrography
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Assessment of motility of the stomach
measured from gastric fistula and electrical activity of the stomach.
Key secondary outcomes
Age, nutritional status, liver function, kidney function, presence or absence of
diabetes mellitus before the gastrostomy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient that gastrostomy was performed
Key exclusion criteria
Refusal of the patients or the family
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | FUMIHIKO |
| Middle name | |
| Last name | KINEKAWA |
Organization
The TAIJYU-KAI Foundation (Social medical corporation)Kaisei General Hospital
Division name
Gastroenterology
Zip code
762-0007
Address
3-5-28, Muromachi, Sakaide City, Kagawa Prefecture, Japan.
TEL
0877-46-1011
kine@kaisei.or.jp
Public contact
Name of contact person
| 1st name | FUMIHIKO |
| Middle name | |
| Last name | KINEKAWA |
Organization
The TAIJYU-KAI Foundation (Social medical corporation)Kaisei General Hospital
Division name
Gastroenterology
Zip code
762-0007
Address
3-5-28, Muromachi, Sakaide City, Kagawa Prefecture, Japan.
TEL
0877-46-1011
Homepage URL
http://www.kaisei.or.jp/
kine@kaisei.or.jp
Sponsor or person
Institute
The TAIJYU-KAI Foundation (Social medical corporation)Kaisei General Hospital
Gastroenterology
Institute
Department
Personal name
Funding Source
Organization
Department of Gastroenterology & Neurology,Faculty of Medicine,Kagawa University
Department of Systems Design Engineering,
Faculty of Engineering Science,
Akita University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Certified Review Board
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan Okayama
Tel
086-235-6503
ouh-crrb@adm.okayama-u.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
社会医療法人財団大樹会総合病院回生病院(香川県)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 15 | Day |
Related information
URL releasing protocol
https://www.kaisei.or.jp/about/clinical-research/
Publication of results
Unpublished
Result
URL related to results and publications
https://www.kaisei.or.jp/about/clinical-research/
Number of participants that the trial has enrolled
22
Results
Primary endpoint:
The results of the internal pressure measurement by the gastric pressure measuring device used this time and the results of the electrogastrogram did not match.
Secondary endpoint:
Although no significant difference was observed, it was considered that the number of days from gastrostomy to death and the number of days until the onset of pneumonia tended to be longer in groups with a high percentage ratio of Normogastria.
Results date posted
| 2025 | Year | 03 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
1)79years old, M 2)95 years old, M 3)67 years old, F
4)90 years old, F5)85 years old, M6)94 years old, M
7)90 years old, M8)81 years old, F9)101 years old, F
10)94 years old, F 11)79 years old, F 12)87 years old, M
13)76 years old, F 14)85 years old, M 15)78 years old, F
16)86 years old, F 17)84 years old, F 18)87 years old, F
19)63 years old, M 20)101 years old, F 21)84 years old, F
22)87 years old, F
Participant flow
Participant flow Date of gastrostomy: 1)2016.10.17,2)2016.10.21,3)2016.10.24,4)2016.12.5,5)2017.1.5,6)2017.1.20,7)2017.1.26,8)2017.3.1,9)2017.3.2,10)2017.5.31,11)2017.6.14,12)2017.7.10,13)2017.7.19,14)2017.7.24,15)2017.8.9,16)2017.8.14,17)2017.9.6,18)2017.9.25,19)2017.10.30,20)2017.12.11,21)2018.2.14,22)2018.2.15
Adverse events
No special instruction
Outcome measures
Average frequency (cpm):
Internal pressure: 3.25
Electrogastrogram: 2.51
P <0.0001
% Ratio of Normogastria (2.4 ~ 3.6 cpm):
Internal pressure: 33.10
Electrogastrogram: 58.18
P <0.0001
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2016 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Intragastric pressure and electrical
activity seven days after gastrostomy.
Age, nutritional state, liver function, kidney function, and The relationship age, nutritional status, liver function, kidney function, and presence or absence of diabetes mellitus.
Results described above and survival rate is going to be estimated.
Management information
Registered date
| 2016 | Year | 07 | Month | 17 | Day |
Last modified on
| 2025 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026749
