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
1 other identifier
interventional
110
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Apr 2012
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 5, 2012
CompletedFirst Posted
Study publicly available on registry
April 17, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFebruary 10, 2015
February 1, 2015
2.3 years
April 5, 2012
February 8, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
1 day
Study Arms (2)
CO2 sufflation group
EXPERIMENTALRoom air sufflation group
EXPERIMENTALInterventions
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
Eligibility Criteria
You may qualify if:
- Patients who have gastroscopy and colonoscopy or ESD for gastric tumor under sedation in department of gastroenterology, Gachon University Gil Medical Center
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Gachon University Gil Medical Center Department of Gastroentorology
Incheon, Incheon, 405-760, South Korea
Related Publications (1)
Kim SY, Chung JW, Park DK, Kwon KA, Kim KO, Kim YJ. Efficacy of carbon dioxide insufflation during gastric endoscopic submucosal dissection: a randomized, double-blind, controlled, prospective study. Gastrointest Endosc. 2015 Dec;82(6):1018-24. doi: 10.1016/j.gie.2015.05.043. Epub 2015 Jul 2.
PMID: 26142555DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principle investigator
Study Record Dates
First Submitted
April 5, 2012
First Posted
April 17, 2012
Study Start
April 1, 2012
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
February 10, 2015
Record last verified: 2015-02