UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011645 |
|---|---|
| Receipt number | R000013613 |
| Scientific Title | Effect of endoscopic resection on gastric motility and gastrointestinal hormones |
| Date of disclosure of the study information | 2013/09/06 |
| Last modified on | 2014/04/03 10:39:11 |
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Basic information
Public title
Effect of endoscopic resection on gastric motility and gastrointestinal hormones
Acronym
Effect of endoscopic resection on gastric motility and gastrointestinal hormones
Scientific Title
Effect of endoscopic resection on gastric motility and gastrointestinal hormones
Scientific Title:Acronym
Effect of endoscopic resection on gastric motility and gastrointestinal hormones
Region
| Japan |
Condition
Condition
early gastric cancer, gastric adenoma
Classification by specialty
| Gastroenterology | Endocrinology and Metabolism | Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The gastrointestinal function is intricately controlled by various gastrointestinal hormones and nerve systems. The endocrine cells of gastrointestinal hormone exist in gastric mucosa, which is playing a role of gastrointestinal function. However, the effects of endoscopic resection of gastric mucosa on the gastrointestinal function have not yet been sufficiently investigated.
The aim of this study is to investigate the effect of endoscopic resection on the gastrointestinal function using ultrasonographic assessment of gastric motility and serological evaluation of gastrointestinal hormones.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Urtrasonographic assessment of gastric motility and serological evaluation of gastrointestinal hormones
Key secondary outcomes
1) Questionnaire
2) Glucose tolerance, metabolic parameter
3) Pathological assessment of gastric mucosa
4) Dynamic assessment of blood flow about gasrtic mucosa
5) Assessment of gastric smooth muscle
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic submucosal dissection
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 will undergo ESD for gastric mucosal neoplasms at Tokyo Medical university
Key exclusion criteria
1) Patients who have severe complication or high-risk for undergoing ESD
2) Patients who have undergone gastrectomy before ESD
3) Patients who expect to become pregnant
4) Patients whose stomach cannot be assessed by ultrasonographic evaluation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shin Kono |
Organization
Tokyo Medical University
Division name
Gastroenterology and Hepatology
Zip code
Address
Nishi-Shinjuku6-7-1, Shinjuku-ku, Tokyo, Japan
TEL
03-3342-6111
shin_kono0527@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shin Kono |
Organization
Tokyo Medical University
Division name
Gastroenterology and Hepatology
Zip code
Address
Nishi-Shinjuku6-7-1, Shinjuku-ku, Tokyo, Japan
TEL
03-3342-6111
Homepage URL
shin_kono0527@yahoo.co.jp
Sponsor or person
Institute
Tokyo Medical University, Division of Gastroenterology and Hepatology
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University, Division of Gastroenterology and Hepatology
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 06 | 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
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 03 | Day |
Last modified on
| 2014 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013613
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
