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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01579071

Enrollment

110

Registered

2012-04-17

Start date

2012-04-30

Completion date

2014-08-31

Last updated

2015-02-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric Tumor

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

Interventions

PROCEDURECO2 or room air insufflation during ESD for gastric tumor

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to 85 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026