Outcome of Carbon Dioxide Versus Air Insufflations During Endoscopic Retrograde Cholangiopancreatography (ERCP)
|ClinicalTrials.gov Identifier: NCT01321203|
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : July 19, 2011
To assess the safety and efficacy of CO2 insufflations during ERCP
To assess the patient's symptoms, abdominal pain and abdominal distension post procedure (ERCP) in the study group.
- Secondary objective:
- To assess the adequacy of bowel distension for adequate luminal visualization
- To assess the peristaltic movement during the ERCP
- To measure the PCO2 level in patient post procedure.
- To assess the amount of sedation required during the procedure.
- To assess saturation and vital signs through out the procedure.
- To assess requirement of buscopan.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Observational Model:||Case Control|
|Official Title:||A Double-blind, Randomized, Controlled Trial of Air Insufflation Versus Carbon Dioxide Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP).|
|Study Start Date :||August 2010|
|Primary Completion Date :||March 2011|
|Study Completion Date :||March 2011|
|Group-A, use of air;|
|Group-B use of CO2|
- Patient comfort post ERCP [ Time Frame: 1 hour ]the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale )
- Abdominal distention prior and post ERCP [ Time Frame: 5 minutes ]The abdominal girth was measured prior to patient shifted to ERCP table. The immdiately post ERCP the abdominal girth measured. A fixed point is marked at the umblical regiem to maintain the site of abdominal girth.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321203
|Asian Institute Of Gastroenterology India|
|Hyderabad, Andra Pradesh, India, 500082|
|Principal Investigator:||Saravanan Arjuanan, MD||Asian Institute of Gastroenterology, India|