Gastric Neoplasm Clinical Trial
Official title:
Learning Curve Analysis for Endoscopic Submucosal Dissection of Gastric Neoplasm
NCT number | NCT05265221 |
Other study ID # | SCH-ESD-2022 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | March 1, 2022 |
Est. completion date | May 31, 2022 |
Verified date | June 2022 |
Source | Soonchunhyang University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Endoscopic submucosal dissection (ESD) for early gastric cancer is a widely accepted treatment option of expanded indication worldwide. ESD is relatively difficult compared with endoscopic mucosal resection, thus, proper training is essential for the safe performance of the procedure. Thus, it is necessary to receive proper training in the procedure for safe performance of ESD. Previous studies reported that there was a learning curve in ESD training and preceptees needed to perform at least 30-40 procedures in order to master this technique. However, there is few study about the association between the clinical characteristics and competence level for gastric ESD.
Status | Completed |
Enrollment | 356 |
Est. completion date | May 31, 2022 |
Est. primary completion date | May 31, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | Inclusion Criteria: - Pathologically confirmed gastric neoplasm Exclusion Criteria: - Age < 20 - History of gastric surgery - Severe systemic disease - Advanced chronic liver disease - Recent history of upper gastrointestinal bleeding |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Soonchunhyang University Hospital | Seoul |
Lead Sponsor | Collaborator |
---|---|
Soonchunhyang University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Resection speed | De?ned as resected lesion size divided by ESD procedure time | 4 weeks | |
Secondary | Complication rate | ESD-related bleeding, gastric perforation, patient's death | 4 weeks |
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