Learning Curve for Gastric Endoscopic Submucosal Dissection

NCT05265221 | Completed

• 1 other identifier: SCH-ESD-2022
• Study Type: observational
• Target: 356
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Resection speed

  Defined as resected lesion size divided by ESD procedure time

  4 weeks

Secondary Outcomes (1)

• Complication rate

  4 weeks

Interventions

Endoscopic submucosal dissection PROCEDURE

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient who underwent endoscopic dissection due to gastric neoplasms

You may qualify if:

• Pathologically confirmed gastric neoplasm

You may not qualify if:

• Age \< 20
• History of gastric surgery
• Severe systemic disease
• Advanced chronic liver disease
• Recent history of upper gastrointestinal bleeding

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Soonchunhyang University Hospital

Seoul, South Korea

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

All resected specimens were immersed in 10 % formalin. Resected ESD specimens were fixed with pins, then sliced serially at 2-mm intervals, and embedded in a paraffin block. If the piecemeal resection was performed, all pieces were reconstructed carefully.

MeSH Terms

Conditions

Stomach Neoplasms

Interventions

Endoscopic Mucosal Resection

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Study Officials

• Jun-Hyung Cho, M.D.

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: February 22, 2022
• First Posted: March 3, 2022
• Study Start: March 1, 2022
• Primary Completion: May 31, 2022
• Study Completion: May 31, 2022
• Last Updated: June 30, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)