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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01579071
First Posted: April 17, 2012
Last Update Posted: February 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Ju Seung Kim, MD, Gachon University Gil Medical Center
  Purpose

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


Condition Intervention Phase
Gastric Tumor Procedure: CO2 or room air insufflation during ESD for gastric tumor Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Official Title: A Randomized, Controlled, Double-blind Trial of the Efficacy and Safety of CO2 vs Room Air Insufflation During ESD for Gastric Tumor

Resource links provided by NLM:


Further study details as provided by Ju Seung Kim, MD, Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Abdominal pain related to each insufflation [ Time Frame: 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:
  • Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 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.


Enrollment: 110
Study Start Date: April 2012
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CO2 sufflation group 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
Experimental: Room air sufflation group 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01579071


Locations
Korea, Republic of
Gachon University Gil Medical Center Department of Gastroentorology
Incheon, Korea, Republic of, 405-760
Sponsors and Collaborators
Gachon University Gil Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ju Seung Kim, MD, principle investigator, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier: NCT01579071     History of Changes
Other Study ID Numbers: GIRBA2681-2012
First Submitted: April 5, 2012
First Posted: April 17, 2012
Last Update Posted: February 10, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases