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N/A
20 Years
80 Years
Not Enrolling
Both
Early Gastric Cancer, Gastric Adenoma

Thank you

Trial Information


Inclusion Criteria:



1. Age, between 20 and 80

2. Early gastric cancer or adenoma, which is indicated by endoscopic submucosal
dissection

3. ECOG performance status 0 or 1

4. American Society of Anesthesiologist Physical Status 1, 2, or 3

Exclusion Criteria:

1. Previous subtotal gastrectomy

2. Previous gastrostomy

3. Repeated endoscopic submucosal dissection

4. Three or more synchronous lesions

5. Allergy to midazolam, propofol, fentanyl, or remifentanil

6. Pregnancy or breast milk feeding

7. Active infection

8. Significant cardiopulmonary disease

9. Active hepatitis or severe hepatic dysfunction

10. Severe renal dysfunction

11. Severe bone marrow dysfunction

12. Severe neurologic or psychotic disorder

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Satisfaction of endoscopists

Outcome Time Frame:

Within 10 minutes from the end of the endoscopic submucosal dissection

Safety Issue:

Yes

Authority:

Korea: Institutional Review Board

Study ID:

4-2012-0661

NCT ID:

NCT01806753

Start Date:

March 2013

Completion Date:

February 2014

Related Keywords:

  • Early Gastric Cancer
  • Gastric Adenoma
  • Endoscopic submucosal dissection
  • Sedation
  • Propofol
  • Midazolam
  • Adenoma
  • Stomach Neoplasms

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