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
Sponsor study identifier
interventional
110
1 country
1
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
August 2014
Actual (reported)Study Completion
August 2014
Actual (reported)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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
August 2014
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
April 5, 2012
Actual (reported)April 17, 2012
Actual (reported)August 2014
Actual (reported)August 2014
Actual (reported)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
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
1 day
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
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Gachon University Gil Medical Center Department of Gastroentorology
Incheon, Incheon, 405-760, South Korea
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.
110 participants (actual enrollment reported by the registry).
First Submitted
April 5, 2012
First Posted
April 17, 2012
Study Start
April 2012
Date type not reportedThis date has not been verified as actual or estimated.
Helicobacter Pylori Eradication After Endoscopic Resection of Gastric Tumors
Contact the study team to confirm eligibility.
Primary Completion
August 2014
Actual (reported)Study Completion
August 2014
Actual (reported)Last Updated
February 10, 2015
Record last verified: 2015-02
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: