Learning Curve for Gastric Endoscopic Submucosal Dissection

June 28, 2022 updated by: Jun-Hyung Cho, Soonchunhyang University Hospital

Learning Curve Analysis for Endoscopic Submucosal Dissection of Gastric Neoplasm

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Procedure: Endoscopic submucosal dissection

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 Type

Observational

Enrollment (Actual)

356

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Korea, Republic of
- - Seoul, Korea, Republic of
    - Soonchunhyang University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patient who underwent endoscopic dissection due to gastric neoplasms

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resection speed Time Frame: 4 weeks	Deﬁned as resected lesion size divided by ESD procedure time	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate Time Frame: 4 weeks	ESD-related bleeding, gastric perforation, patient's death	4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Soonchunhyang University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

May 31, 2022

Study Registration Dates

First Submitted

February 22, 2022

First Submitted That Met QC Criteria