UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026988 |
|---|---|
| Receipt number | R000030945 |
| Scientific Title | Is there the need for 2nd. look endoscopy after endoscopic submucosal dissection for gastric carcinoma/adenoma? |
| Date of disclosure of the study information | 2017/04/13 |
| Last modified on | 2022/01/22 18:54:33 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Is there the need for 2nd. look endoscopy after endoscopic submucosal dissection for gastric carcinoma/adenoma?
Acronym
Is there the need for 2nd. look endoscopy after gastric ESD?
Scientific Title
Is there the need for 2nd. look endoscopy after endoscopic submucosal dissection for gastric carcinoma/adenoma?
Scientific Title:Acronym
Is there the need for 2nd. look endoscopy after gastric ESD?
Region
| Japan |
Condition
Condition
Gastric adenoma, Early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the need for 2nd. look endoscopy after endoscopic submucosal dissection for gastric carcinoma/adenoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
The rate of post procedural bleeding after gastric ESD (analysis with historical control group with 2nd. look endoscopy)
Key secondary outcomes
The rate of post procedural bleeding after gastric ESD according to tumor characteristics, another factors, and the rate of thrombosis (analysis with historical control group with 2nd. look endoscopy)
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 after gastric ESD without intraprocedural complication who have high-risk factor for post procedural bleeding
Key exclusion criteria
Patients with intraprocedural complication during gastric ESD
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Makoto |
| Middle name | |
| Last name | Arai |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba, 260-8670, Japan
TEL
+81-43-226-2083
araim-cib@umin.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Maruoka |
Organization
Chiba University Hospital
Division name
Department of Gastroenterology
Zip code
260-8670
Address
1-8-1, Inohana, Chuo-ku, Chiba, 260-8670, Japan
TEL
+81-43-226-2083
Homepage URL
maruoka-cib@umin.ac.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Chiba University
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
Graduate School of Medicine, Chiba University
Address
1-8-1, Inohana, Chuo-ku, Chiba, 260-8670, Japan
Tel
+81-43-222-7171
igaku-rinri@office.chiba-u.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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 04 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/epdf/10.1177/2050640618792819
Number of participants that the trial has enrolled
31
Results
After propensity score-matching,38 subjects (19 subjects in each group) were enrolled. No significant differences were observed in the rate of post-operative bleeding (POB) between the two groups (second-look-endoscopy [SLE] group, 5.3%; non-SLE group, 10.5%).
Results date posted
| 2022 | Year | 01 | Month | 22 | Day |
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
| 2017 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2017 | Year | 04 | Month | 02 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To reveal the need for 2nd. look endoscopy after gastric ESD
Management information
Registered date
| 2017 | Year | 04 | Month | 13 | Day |
Last modified on
| 2022 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030945
