Learning Curve for Gastric Endoscopic Submucosal Dissection

Completed

• Conditions: Gastric Neoplasm; Endoscopic Submucosal Dissection

• Registration Number: NCT05265221
• Lead Sponsor: Soonchunhyang University Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-02-22
• Study First Submitted QC: 2022-02-22
• Study Start: 2022-03-01
• Study First Posted: 2022-03-03
• Primary Completion: 2022-05-31
• Study Completion: 2022-05-31
• Status Verified: 2022-06
• Last Update Submitted: 2022-06-28
• Last Update Posted: 2022-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 356

Inclusion Criteria

• Pathologically confirmed gastric neoplasm

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Exclusion Criteria

• Age < 20
• History of gastric surgery
• Severe systemic disease
• Advanced chronic liver disease
• Recent history of upper gastrointestinal bleeding

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Resection speed	4 weeks	Defined as resected lesion size divided by ESD procedure time

Secondary Outcome Measures

Name	Time	Method
Complication rate	4 weeks	ESD-related bleeding, gastric perforation, patient's death

Trial Locations

Locations (1)

Soonchunhyang University Hospital; 🇰🇷 Seoul, Korea, Republic of