UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050786 |
|---|---|
| Receipt number | R000057868 |
| Scientific Title | Pre-treatment diagnosis of ulcerated gastric cancer invasion depth and ESD safety assessment for anti-acid-treated early gastric cancer: cohort study |
| Date of disclosure of the study information | 2023/04/10 |
| Last modified on | 2023/08/05 14:07:25 |
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Basic information
Public title
A retrospective study of endoscopic submucosal dissection after ulcer treatment for early gastric cancer with open ulcer
Acronym
A retrospective study of endoscopic submucosal dissection after ulcer treatment for early gastric cancer with open ulcer
Scientific Title
Pre-treatment diagnosis of ulcerated gastric cancer invasion depth and ESD safety assessment for anti-acid-treated early gastric cancer: cohort study
Scientific Title:Acronym
Pre-treatment diagnosis of ulcerated gastric cancer invasion depth and ESD safety assessment for anti-acid-treated early gastric cancer: cohort study
Region
| Japan |
Condition
Condition
early gastric cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Early gastric cancer with open ulcer is difficult to diagnose in terms of depth, and even after healing of the ulcer, submucosal dissection may not be easy. Although the frequency of surgical indications is relatively high, endoscopic submucosal dissection (ESD) after ulcer healing has not been fully investigated. In this study, we retrospectively reviewed ESD cases for early gastric cancer complicated with ulcer performed at our hospital from April 2014 to March 2022, and examined the correct diagnosis rate of preoperative diagnosis and the safety of ESD.
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Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Diagnosis of depth of early gastric cancer complicated by ulcer, presence of bleeding as a complication of endoscopic treatment, and presence of perforation as a complication of endoscopic treatment.
Key secondary outcomes
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A diagnosed patient with early gastric cancer complicated with ulcer by upper gastrointestinal endoscopy.
Key exclusion criteria
Cases of early gastric cancer complicated with ulcer not suitable for endoscopic treatment.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Suto |
Organization
International University of Health and Welfare Hospital
Division name
Department of Gastroenterology
Zip code
3292763
Address
Iguchi, Nasushiobara, Tochigi 329-2763, Japan
TEL
0287-39-3060
daisuto@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Daisuke |
| Middle name | |
| Last name | Suto |
Organization
International University of Health and Welfare Hospital
Division name
Department of Gastroenterology
Zip code
329-2763
Address
Iguchi, Nasushiobara, Tochigi 329-2763, Japan
TEL
0287-39-3060
Homepage URL
daisuto@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare Hospital
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare Hospital
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
International University of Health and Welfare Hospital
Address
Iguchi, Nasushiobara, Tochigi 329-2763, Japan
Tel
0287393060
daisuto@iuhw.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 | 04 | Month | 10 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10328654/pdf/ms9-85-3269.pdf
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10328654/pdf/ms9-85-3269.pdf
Number of participants that the trial has enrolled
12
Results
The accuracy of the invasion depth diagnosis was 38.3%. According to the pretreatment diagnosis of invasion depth, gastrectomy was recommended for 41.7% (5/12) of the cases. However, histological examination revealed that additional gastrectomy was required in only one case (8.3%). Thus, in four out of five patients unnecessary gastrectomy could be avoided. Post-ESD mild melena occurred in only one case, and there was no case of perforation.
Results date posted
| 2023 | Year | 08 | Month | 05 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 06 | Month | 05 | Day |
Baseline Characteristics
Patients with ulcerated early gastric cancer and indicated for endoscopic submucosal dissection
Participant flow
Patients with ulcerated early gastric cancer and indicated for endoscopic submucosal dissection
Adverse events
None
Outcome measures
Bleeding and perforation
Plan to share IPD
None
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 29 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
| 2023 | Year | 08 | Month | 05 | Day |
Date trial data considered complete
| 2023 | Year | 08 | Month | 05 | Day |
Date analysis concluded
| 2023 | Year | 08 | Month | 05 | Day |
Other
Other related information
Diagnosis of depth and indication for endoscopic treatment of early gastric cancer complicated with ulcer
Management information
Registered date
| 2023 | Year | 04 | Month | 07 | Day |
Last modified on
| 2023 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057868
