MedTrace Logo

Learning Curve for Gastric Endoscopic Submucosal Dissection

NCT05265221 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 356

Last updated 2022-06-30

No results posted yet for this study

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.

Conditions

  • Endoscopic Submucosal Dissection
  • Gastric Neoplasm

Interventions

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.

Sponsors & Collaborators

  • Soonchunhyang University Hospital

    lead OTHER

Principal Investigators

  • Jun-Hyung Cho, M.D. · Soonchunhyang University Hospital

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2022-05-31
Completion
2022-05-31

Countries

  • South Korea

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05265221 on ClinicalTrials.gov