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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date June 2022
Source Soonchunhyang University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

This study aims to evaluate the clinical outcomes of ESD and to describe the learning curve for ESD of the gastric neoplasm, based on the analysis of a single endoscopist's experience.


Recruitment information / eligibility

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

Study Design


Intervention

Procedure:
Endoscopic submucosal dissection
ESD was performed under conscious sedation. For sedation, midazolam and/or propofol were administered intravenously, with cardiorespiratory monitoring. Initially, indigo carmine dye was sprayed onto the tumor to clarify the margin. Then, markings were made 10 mm outside the tumor margin using argon plasma coagulation. After marking, a mixture of sodium hyaluronate with indigo carmine and epinephrine was injected into the submucosa outside the marking dots. Circumferential mucosal incision and submucosal dissection were performed using a Dual and/or IT knife. During the procedure, immediate bleeding was treated by Coagrasper. After ESD, chest and abdominal plain radiography were performed routinely for detection of gastric perforation.

Locations

Country Name City State
Korea, Republic of Soonchunhyang University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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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