Performance of Endoscopic Submucosal Dissection According to the Sedation Method

Not Applicable

Completed

• Conditions: Early Gastric Cancer; Gastric Adenoma
• Interventions: Procedure: Intermittent midazolam/propofol injection controlled by endoscopist; Procedure: Continuous propofol infusion with opioid administration

• Registration Number: NCT01806753
• Lead Sponsor: Yonsei University

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 the investigators previous retrospective study, en bloc resection and complete resection rates, and procedure time could be improved by sedation with continuous propofol infusion with opioid administration by anesthesiologists. However, there are several limitations to the study including retrospective design. The investigators aimed to evaluate the relationship among sedation methods, satisfaction of endoscopists or patients, clinical outcomes, and complications after endoscopic submucosal dissection for gastric neoplasia.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-03
• Study First Submitted: 2013-03-05
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-07
• Status Verified: 2014-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Last Update Submitted: 2014-01-28
• Last Update Posted: 2014-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 157

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
midazolam/propofol injection	Intermittent midazolam/propofol injection controlled by endoscopist	Intermittent midazolam/propofol injection controlled by endoscopist
propofol infusion	Continuous propofol infusion with opioid administration	Continuous propofol infusion with opioid administration

Primary Outcome Measures

Name	Time	Method
Satisfaction of endoscopists	Within 10 minutes from the end of the endoscopic submucosal dissection

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of