Learning Curve for Gastric Endoscopic Submucosal Dissection

Gastric Neoplasm Clinical Trial

Official title:

Learning Curve Analysis for Endoscopic Submucosal Dissection of Gastric Neoplasm

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05265221
• Other study ID #: SCH-ESD-2022
• Status: Completed
• Start date: March 1, 2022
• Est. completion date: May 31, 2022

Study information

• Verified date: June 2022
• Source: Soonchunhyang University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 356
• Est. completion date: May 31, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endoscopic Submucosal Dissection
• Gastric Neoplasm
• Neoplasms
• Stomach Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Soonchunhyang University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Resection speed	De?ned as resected lesion size divided by ESD procedure time	4 weeks
Secondary	Complication rate	ESD-related bleeding, gastric perforation, patient's death	4 weeks