Status:
COMPLETED
Performance of Endoscopic Submucosal Dissection According to the Sedation Method
Lead Sponsor:
Yonsei University
Conditions:
Early Gastric Cancer
Gastric Adenoma
Eligibility:
All Genders
20-80 years
Phase:
NA
Brief Summary
Although proper sedation is mandatory for endoscopic procedures such as endoscopic submucosal dissection, the effects of sedation on ESD performance and complications have not been fully evaluated. In...
Eligibility Criteria
Inclusion
- Age, between 20 and 80
- Early gastric cancer or adenoma, which is indicated by endoscopic submucosal dissection
- ECOG performance status 0 or 1
- American Society of Anesthesiologist Physical Status 1, 2, or 3
Exclusion
- Previous subtotal gastrectomy
- Previous gastrostomy
- Repeated endoscopic submucosal dissection
- Three or more synchronous lesions
- Allergy to midazolam, propofol, fentanyl, or remifentanil
- Pregnancy or breast milk feeding
- Active infection
- Significant cardiopulmonary disease
- Active hepatitis or severe hepatic dysfunction
- Severe renal dysfunction
- Severe bone marrow dysfunction
- Severe neurologic or psychotic disorder
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
157 Patients enrolled
Trial Details
Trial ID
NCT01806753
Start Date
March 1 2013
End Date
January 1 2014
Last Update
January 30 2014
Active Locations (1)
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1
Severance Hospital
Seoul, Seoul, South Korea, 120-752