Efficacy and Safety of CO2 vs Room Air Insufflation During ESD for Gastric Tumor

Study Overview
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Brief Summary
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Insufflation is essential procedure to observe the lumen of gastrointestinal tract in gastroscopy or colonoscopy Currently, most of hospital in Korea are using room air for insufflation According to recent clinical studies have shown that carbon dioxide have better safe and reduce stomachache than room air when endoscopy and endoscopic procedure is performed. However, there was still no research data or study in Korea. In this study, the investigators will try to make comparison between Carbon dioxide and room air insufflation for endoscopic submucosal dissection for Gastric Tumor and investigate the efficacy and safety

Official Title
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A Randomized, Controlled, Double-blind Trial of the Efficacy and Safety of CO2 vs Room Air Insufflation During ESD for Gastric Tumor

Conditions
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Gastric Tumor

Intervention / Treatment
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* Procedure: CO2 or room air insufflation during ESD for gastric tumor


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who have gastroscopy and colonoscopy or ESD for gastric tumor under sedation in department of gastroenterology, Gachon University Gil Medical Center Exclusion Criteria: Age : < 19 years old Underlying disease : COPD requiring O2 Known CO2 retention Opiate abuse for chronic pain Nonreader or short in understanding Pregnancy Any medical instabilities expected to not be in safe

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CO2 sufflation group<br> | Procedure: CO2 or room air insufflation during ESD for gastric tumor<br>* CO2 insufflation group : CO2 will be insufflated via the endoscope during procedure as needed, Room air insufflation group : Room air will be insufflated via the endoscope during procedure as needed<br>|
| Experimental: Room air sufflation group<br> | Procedure: CO2 or room air insufflation during ESD for gastric tumor<br>* CO2 insufflation group : CO2 will be insufflated via the endoscope during procedure as needed, Room air insufflation group : Room air will be insufflated via the endoscope during procedure as needed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal pain related to each insufflation | Patients will be received questionnaire (100mm visual analogue scale, VAS) and record their score in 0, 1, 3, 6, 24 hours after endoscopic procedure. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability | The investigators will check the side effect during and after pocedure. If any side effect occur, the investigators will stop the procedure and act right away. | 1 day |