UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042741 |
|---|---|
| Receipt number | R000048763 |
| Scientific Title | Evaluation of residual gastric emptying capacity after gastrectomy by 13C breath test |
| Date of disclosure of the study information | 2020/12/14 |
| Last modified on | 2022/05/11 20:42:13 |
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Basic information
Public title
Evaluation of residual gastric emptying capacity after gastrectomy by 13C breath test
Acronym
Evaluation of residual gastric emptying capacity after gastrectomy
Scientific Title
Evaluation of residual gastric emptying capacity after gastrectomy by 13C breath test
Scientific Title:Acronym
Evaluation of residual gastric emptying capacity after gastrectomy
Region
| Japan |
Condition
Condition
Gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the digestive and absorptive capacity of post-gastrectomy patients using a non-invasive test of 13C intake and expiratory collection and analysis.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison of digestive and absorptive capacity by 13C breath test from preoperative to 1, 3, 6, and 12 months postoperatively
Key secondary outcomes
Assessment of postoperative nutritional status (blood test results, body weight, body fat and muscle mass measurements), recurrence-free survival, and overall survival
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Disease group
Disease name : gastric tumor (including esophagogastric junction tumor)
Stage : Stage does not matter
Gender : no limitation
Age : 20 years or older (at the time of registration)
2. Healthy control group
Gender : 10 males and 10 females each
Age : 40-70 years (at the time of enrollment)
Those who have obtained consent for participation in this study by signing a consent.
Key exclusion criteria
1. Disease group
Patients with severe diabetes or metabolic disease.
Those with gastric stenosis or intestinal obstruction.
Those who have refused to participate in the study.
Pregnant or lactating women.
2.Healthy control group
Those with diabetes or serious underlying diseases
Those with a history of stomach or intestinal surgery (excluding appendicitis and cholelithiasis).
Those who have refused to participate in the study.
Those who are pregnant or lactating.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | |
| Last name | Kaida |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
520-2192
Address
Tsukinowa-cho, Otsu, Shiga, Japan
TEL
077-548-2238
kaida@belle.shiga-med.ac.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Kaida |
Organization
Shiga University of Medical Science
Division name
Department of Surgery
Zip code
520-2192
Address
Tsukinowa-cho, Otsu, Shiga, Japan
TEL
077-548-2238
Homepage URL
kaida@belle.shiga-med.ac.jp
Sponsor or person
Institute
Department of Surgery, Shiga University of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Shiga University of Medical Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Surgery, Shiga University of Medical Science
Address
Tsukinowa-cho, Otsu, Shiga, Japan
Tel
077-548-2238
hqsurge1@belle.shiga-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
滋賀医科大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 14 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 14 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
To evaluate the digestive and absorptive capacity of post-gastrectomy patients by non-invasive tests of 13C intake and expiratory collection and analysis.
Management information
Registered date
| 2020 | Year | 12 | Month | 14 | Day |
Last modified on
| 2022 | Year | 05 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048763
