UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050275 |
|---|---|
| Receipt number | R000057249 |
| Scientific Title | Examination of how to start eating after endoscopic submucosal dissection |
| Date of disclosure of the study information | 2023/02/08 |
| Last modified on | 2023/02/08 20:45:39 |
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Basic information
Public title
Examination of how to start eating after endoscopic submucosal dissection
Acronym
Consider starting a diet after ESD
Scientific Title
Examination of how to start eating after endoscopic submucosal dissection
Scientific Title:Acronym
Examination of how to start eating after endoscopic submucosal dissection
Region
| Japan |
Condition
Condition
Esophageal cancer, gastric cancer, colorectal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Endoscopic submucosal dissection (ESD) is currently being safely treated for early-stage cancer in Japan and abroad. However, there are no clear regulations regarding the resumption of diet after ESD, and in many cases, it is confirmed that there are no incidents after a few days of treatment. In this study, using a pain scale of subjective symptoms after ESD and CT scans, we will consider whether to gradually eat or start with a normal diet by taking into account the contingency and blood collection data after treatment, and examine whether it can lead to a shortening of the hospitalization period.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence or absence of free air on CT after ESD. Pain scores on NRS the next day after treatment, values of inflammatory response in blood sampling, vital signs, etc. will be examined, and the difference in contingency and length of hospitalization between the group eating from normal diet and the group eating from liquid diet will be examined.
Key secondary outcomes
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
| Device,equipment |
Interventions/Control_1
Check for free air by CT scan for patients after ESD
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
All cases of ESD at our hospital
Key exclusion criteria
Pregnant women, minors, and those who cannot give consent
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masashi |
| Middle name | |
| Last name | Ono |
Organization
Toho University Medical Center Omori Hospital
Division name
Department of Gastroenterology
Zip code
1438541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
0337624151
masashi.ono@med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | Masashi |
| Middle name | |
| Last name | Ono |
Organization
Toho University Medical Center Omori Hospital
Division name
Department of Gastroenterology
Zip code
1438541
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
TEL
0337624151
Homepage URL
masashi.ono@med.toho-u.ac.jp
Sponsor or person
Institute
Other
Institute
Department
Personal name
Funding Source
Organization
None
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
Toho University Medical Center Omori Hospital
Address
6-11-1 Omorinishi, Ota-ku, Tokyo
Tel
0337624151
masashi.ono@med.toho-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
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | Month | 08 | 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 | 12 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 12 | Day |
Last follow-up date
| 2025 | 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
| 2023 | Year | 02 | Month | 08 | Day |
Last modified on
| 2023 | Year | 02 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057249
