UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054827 |
|---|---|
| Receipt number | R000062649 |
| Scientific Title | A study to evaluate the safety of early initiation of soft diet after gastric ESD using endoscopic hand-suturing. |
| Date of disclosure of the study information | 2024/07/02 |
| Last modified on | 2024/06/30 14:19:14 |
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Basic information
Public title
A study to evaluate the safety of early initiation of soft diet after gastric ESD using endoscopic hand-suturing.
Acronym
The safety of early initiation of soft diet after gastric ESD using endoscopic hand-suturing.
Scientific Title
A study to evaluate the safety of early initiation of soft diet after gastric ESD using endoscopic hand-suturing.
Scientific Title:Acronym
The safety of early initiation of soft diet after gastric ESD using endoscopic hand-suturing.
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate the safety and validity of early initiation of soft food after ESD with endoscopic hand-suturing for early gastric cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The rate of complications (delayed bleeding/ perforation) within 28 days in the group that started a solid diet early after ESD plus endoscopic hand-suturing.
Key secondary outcomes
The rate of successfulness of EHS procedures
The rate of incidence of ESD-related symptoms (nausea, abdominal pain, etc.)
The suture retention rate at 1 week/day after ESD
Nutritional status at 1 week after ESD
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Endoscopic hand-suturing
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
1. Scheduled to undergo ESD for early gastric cancer with a diameter of 3 cm or less
2. Age at enrollment is 20 years or older
3. Performance status is 0 to 1 according to ECOG criteria
4. Patients from whom we have not obtained written informed consent for participation in the study
Key exclusion criteria
1) Patients with hemorrhagic diathesis if any of the following applies,
Platelet count is less than 50,000/mm3 or PT-INR is 2 or higher with no anticoagulants
Patients with liver cirrhosis fall under B-C in the Child-Pugh score.
Patients with chronic renal failure on maintenance dialysis
2) Patients who can not be withdrawn from antithrombotic medications according to the JGES guidelines
3) Patients with lesions for which EHS is difficult due to site/technical difficulty
4) Patients with a history of surgical gastrectomy excluding partial resection
5) Patients who can not give consent for this study
Target sample size
25
Research contact person
Name of lead principal investigator
| 1st name | Tsukasa |
| Middle name | |
| Last name | Yamakawa |
Organization
Sapporo Medical University
Division name
Gastroenterology and Hepatology
Zip code
060-8543
Address
Nishi 17-chome, Minami 1-jo, Chuo-ku, Sapporo, Hokkaido.
TEL
0116112111
awakamay.dem1@gmail.com
Public contact
Name of contact person
| 1st name | Tsukasa |
| Middle name | |
| Last name | Yamakawa |
Organization
Sapporo Medical University
Division name
Gastroenterology and Hepatology
Zip code
060-8543
Address
Nishi 17-chome, Minami 1-jo, Chuo-ku, Sapporo, Hokkaido.
TEL
0116112111
Homepage URL
https://sapporo-med-gastroenterology.jp/patients/
awakamay.dem1@gmail.com
Sponsor or person
Institute
Sapporo Medical University
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
Sapporo Medical University
Address
Nishi 17-chome, Minami 1-jo, Chuo-ku, Sapporo, Hokkaido.
Tel
0116112111
rskk@sapmed.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
札幌医科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 02 | 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
| 2024 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2026 | 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 | 06 | Month | 30 | Day |
Last modified on
| 2024 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062649
