UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033988 |
|---|---|
| Receipt number | R000038756 |
| Scientific Title | A multi-centered phase I study of feasibility in endoscopic hand suturing (EHS) of mucosal defects after gastric endoscopic submucosal dissection |
| Date of disclosure of the study information | 2018/09/10 |
| Last modified on | 2019/06/28 19:48:00 |
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Basic information
Public title
A multi-centered phase I study of feasibility in endoscopic hand suturing (EHS) of mucosal defects after gastric endoscopic submucosal dissection
Acronym
G-HANDSOME phase I study
Scientific Title
A multi-centered phase I study of feasibility in endoscopic hand suturing (EHS) of mucosal defects after gastric endoscopic submucosal dissection
Scientific Title:Acronym
G-HANDSOME phase I study
Region
| Japan |
Condition
Condition
early gastric cancers
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate feasibility and shortening potential of hospitalization in endoscopic hand suturing for a mucosal defect after gastric endoscopic submucosal dissection
Basic objectives2
Others
Basic objectives -Others
feasibility
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Phase I
Assessment
Primary outcomes
suture-maintenance rate on the postoperative day 3
Key secondary outcomes
completeness of suturing, postoperative bleeding rate, postoperative minor bleeding rate, adverse events (excluding postoperative bleeding), suturing duration, postoperative bleeding rate with/without anti-thrombotic agents
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 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) clinically-diagnosed early gastric cancer/gastric adenoma, 3 cm or less
2) cases which are planned to remove by ESD
3) 20 years-old or more
4) performance status 0-1 according to the ECOG criteria
5) informed consent obtained
Key exclusion criteria
1) bleeding tendency
2) liver cirrhosis (Child-Pugh score: B-C)
3) chronic kidney disease on hemodialysis
4) history of endoscopic treatment 1 month prior to the current study
5) cases in which doctors in charge regarded as unsuitable to inclusion for the current study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Osamu Goto |
Organization
Nippon Medical School Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-3822-2131
o-goto@nms.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Osamu Goto |
Organization
Nippon Medical School Hospital
Division name
Gastroenterology and Hepatology
Zip code
Address
1-1-5, Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan
TEL
03-3822-2131
Homepage URL
o-goto@nms.ac.jp
Sponsor or person
Institute
Nippon Medical School
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2018 | Year | 09 | Month | 10 | 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
Completed
Date of protocol fixation
| 2018 | Year | 08 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 10 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 06 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 01 | Day |
Last modified on
| 2019 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038756
