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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ju Seung Kim, MD, Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01579071
First received: April 5, 2012
Last updated: February 8, 2015
Last verified: February 2015
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 Gachon University Gil Medical Center:

Primary Outcome Measures:
  • Abdominal pain related to each insufflation [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

Ages Eligible for Study:   19 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: April 5, 2012
Last Updated: February 8, 2015
Health Authority: Korea: Institutional Review Board

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

ClinicalTrials.gov processed this record on July 27, 2015