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

Gachon University Gil Medical Center110 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

110

Conditions

Gastric Tumor

Interventions

CO2 or room air insufflation during ESD for gastric tumor

Eligibility

Sex: ALLMin age: 19 YearsMax age: 85 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 1 day

Secondary Outcomes

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.