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

Phase 4

Completed

• Conditions: Gastric Tumor
• Interventions: Procedure: CO2 or room air insufflation during ESD for gastric tumor

• Registration Number: NCT01579071
• Lead Sponsor: Gachon University Gil Medical Center

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-05
• Study First Submitted QC: 2012-04-14
• Study First Posted: 2012-04-17
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-08
• Last Update Posted: 2015-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CO2 sufflation group	CO2 or room air insufflation during ESD for gastric tumor	-
Room air sufflation group	CO2 or room air insufflation during ESD for gastric tumor	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	1 day	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.

Trial Locations

Locations (1)

Gachon University Gil Medical Center Department of Gastroentorology; 🇰🇷 Incheon, Korea, Republic of