NCT05265221

Learning Curve for Gastric Endoscopic Submucosal Dissection

Learning Curve Analysis for Endoscopic Submucosal Dissection of Gastric Neoplasm

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 356 (actual)
• Sponsor: Soonchunhyang University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Endoscopic Submucosal Dissection
• Gastric Neoplasm

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-01
• Primary completion: 2022-05-31
• Completion: 2022-05-31
• First posted: 2022-03-03
• Last updated: 2022-06-30

Locations

1 site across 1 country: South Korea