UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055513 |
|---|---|
| Receipt number | R000063436 |
| Scientific Title | A Study on the Utilization of a Colonoscopic Preparation Meal for Gastric Residue Retention in Upper Gastrointestinal Endoscopy after Distal Gastrectomy |
| Date of disclosure of the study information | 2024/09/17 |
| Last modified on | 2024/09/16 18:55:02 |
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Basic information
Public title
A Study on the Utilization of a Colonoscopic Preparation Meal for Gastric Residue Retention in Upper Gastrointestinal Endoscopy after Distal Gastrectomy
Acronym
CLEAR-G test
Scientific Title
A Study on the Utilization of a Colonoscopic Preparation Meal for Gastric Residue Retention in Upper Gastrointestinal Endoscopy after Distal Gastrectomy
Scientific Title:Acronym
CLEAR-G test (Colonoscopic Preparation Meal for Low-residue Endoscopic Assessment after Gastrectomy)
Region
| Japan |
Condition
Condition
Cases after distal gastrectomy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the reduction of gastric residue and improvement of observation ability in EGD after distal gastrectomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gastric residue volume (evaluated by the RGB classification: Residue, Gastritis, Bile)
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
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Before performing upper gastrointestinal endoscopy (EGD) on patients after distal gastrectomy, they will be asked to consume a colonoscopic preparation meal (ClearThru). Patients will be instructed to take ClearThru by 9:00 PM on the day before the EGD, after which they will fast. The EGD will be performed the following day, and during the procedure, the gastric residue volume and observation capability will be evaluated.
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
Cases with gastric residue observed during EGD after distal gastrectomy.
Cases that are 20 years or older at the time of enrollment.
Cases where written consent to participate in this study has been obtained from the individual.
Key exclusion criteria
Cases with uncontrolled infections.
Cases with severe drug allergies.
Pregnant women, those with the possibility of pregnancy, or breastfeeding women.
Cases with severe mental disorders.
Cases deemed inappropriate for the safe conduct of this study by the principal investigator or co-investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuro |
| Middle name | |
| Last name | Otsuka |
Organization
Handa City Hospital
Division name
Department of Gastroenterology
Zip code
475-8599
Address
2-29 Toyo-cho, Handa City, Aichi
TEL
0569-22-9881
yurihaiwa.0913@gmail.com
Public contact
Name of contact person
| 1st name | Yuriha |
| Middle name | |
| Last name | Aoi |
Organization
Handa City Hospital
Division name
Department of Gastroenterology
Zip code
475-8599
Address
2-29 Toyo-cho, Handa City, Aichi
TEL
0569-22-9881
Homepage URL
yurihaiwa.0913@gmail.com
Sponsor or person
Institute
Handa City Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Handa City Hospital
Address
2-29 Toyo-cho, Handa City, Aichi
Tel
0569-22-9881
yurihaiwa.0913@gmail.com
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
| 2024 | Year | 09 | Month | 17 | 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
| 2024 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 21 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2024 | Year | 09 | Month | 16 | Day |
Last modified on
| 2024 | Year | 09 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063436
