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

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

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

No

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

February 22, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

June 30, 2022

Last Update Submitted That Met QC Criteria

June 28, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCH-ESD-2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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