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

Gastric Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01579071
• Other study ID #: GIRBA2681-2012
• Status: Completed
• Phase: Phase 4
• First received: April 5, 2012
• Last updated: February 8, 2015
• Start date: April 2012
• Est. completion date: August 2014

Study information

• Verified date: February 2015
• Source: Gachon University Gil Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Gastric Tumor
• Stomach Neoplasms

Intervention

Procedure:
• CO2 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

Locations

Country	Name	City	State
Korea, Republic of	Gachon University Gil Medical Center Department of Gastroentorology	Incheon

Sponsors (1)

Lead Sponsor	Collaborator
Gachon University Gil Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes