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| Name | Class |
|---|---|
| Olympic Medical | INDUSTRY |
| National Institutes of Health (NIH) | NIH |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| I | Experimental |
| |
| II | Placebo Comparator | Room air will be used for insufflation as the placebo comparator arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CO2 insufflation | Other | The bowel lumen will be insufflated with CO2 during the endoscopy (as compared to room air). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal pain (VAS). | pre-procedure and up to 24 hours post-procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| The extent of CO2 retention. | Intra-procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Evan S. Dellon, MD MPH | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina-Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20493485 | Derived | Dellon ES, Velayudham A, Clarke BW, Isaacs KL, Gangarosa LM, Galanko JA, Grimm IS. A randomized, controlled, double-blind trial of air insufflation versus carbon dioxide insufflation during ERCP. Gastrointest Endosc. 2010 Jul;72(1):68-77. doi: 10.1016/j.gie.2010.01.041. Epub 2010 May 20. |
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| Room air insufflation | Other | During the ERCP, room air will be insufflated (current standard clinical practice) as a placebo comparator. |
|
| ID | Term |
|---|---|
| D002779 | Cholestasis |
| ID | Term |
|---|---|
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
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