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

Gachon University Gil Medical Center

Status and phase: Completed; Phase 4

Conditions: Gastric Tumor

Treatments: Procedure: CO2 or room air insufflation during ESD for gastric tumor

Study type: Interventional

Funder types: Other

Identifiers

NCT01579071

GIRBA2681-2012

Details and patient eligibility

About

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

Enrollment: 110 patients

Sex: All

Ages: 19 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

110 participants in 2 patient groups

CO2 sufflation group

Experimental group

Treatment:

Procedure: CO2 or room air insufflation during ESD for gastric tumor

Room air sufflation group

Experimental group

Treatment:

Procedure: CO2 or room air insufflation during ESD for gastric tumor