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Learning Curve for Gastric Endoscopic Submucosal Dissection

Learning Curve Analysis for Endoscopic Submucosal Dissection of Gastric Neoplasm

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05265221
Enrollment
356
Registered
2022-03-03
Start date
2022-03-01
Completion date
2022-05-31
Last updated
2022-06-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endoscopic Submucosal Dissection, Gastric Neoplasm

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.

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.

Interventions

PROCEDUREEndoscopic 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

Soonchunhyang University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Resection speed4 weeksDefined as resected lesion size divided by ESD procedure time

Secondary

MeasureTime frameDescription
Complication rate4 weeksESD-related bleeding, gastric perforation, patient's death

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026