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Completed

NCT Number: NCT01579071

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

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

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Key information

Conditions

Gastric Tumor Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site Stomach Diseases Stomach Neoplasms

Age range

19 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Gachon University Gil Medical Center Department of Gastroentorology

Incheon, 405-760, South Korea

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO2 or room air insufflation during ESD for gastric tumor

Procedure

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

Primary outcomes

  1. 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 outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Gachon University Gil Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Apr 17, 2012
Registry last updated
Feb 10, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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