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Completed

NCT Number: NCT00685386

A Randomized Controlled Trial (RCT) of Carbon Dioxide Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP)

The purpose of this study it to conduct a randomized, controlled, double-blinded trial of carbon dioxide (CO2) versus air insufflation during endoscopic retrograde cholangiopancreatography (ERCP).

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Key information

Conditions

Cholestasis Bile Duct Diseases Biliary Tract Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of North Carolina-Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • age >= 18 years
  • referred for ERCP for any indication at UNC Hospitals

Exclusion criteria

  • age < 18 years
  • COPD requiring oxygen or with known CO2 retention
  • any medical condition with known CO2 retention
  • medical instability making the procedure unsafe
  • absolute requirement for same-day second endoscopy
  • ERCP performed in the OR or under GA
  • inability to read or understand English
  • use of chronic opiates for pain
  • pregnant women

Treatment and study plan

CO2 insufflation

Other

The bowel lumen will be insufflated with CO2 during the endoscopy (as compared to room air).

Other names: Olympus XUCR manufacured by Olympus Medical.

Room air insufflation

Other

During the ERCP, room air will be insufflated (current standard clinical practice) as a placebo comparator.

Primary outcomes

  1. Abdominal pain (VAS).

    Time frame: pre-procedure and up to 24 hours post-procedure.

Secondary outcomes

  1. The extent of CO2 retention.

    Time frame: Intra-procedure

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institutes of Health (NIH)
  • Olympic Medical

Registry information

Official study title

A Randomized, Controlled, Double-blind Trial of CO2 Versus Air Insufflation During Endoscopic Retrograde Cholangiopancreatography

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
May 28, 2008
Registry last updated
Jan 24, 2013

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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