Ignite Creation Date:
2025-12-24 @ 7:12 PM
Ignite Modification Date:
2025-12-28 @ 10:22 AM
Study NCT ID:
NCT01321203
Status:
COMPLETED
Last Update Posted:
2011-07-19
First Post:
2011-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome of Carbon Dioxide Versus Air Insufflations During Endoscopic Retrograde Cholangiopancreatography (ERCP)
Sponsor:
Asian Institute of Gastroenterology, India
Organization:
Study Overview
Official Title:
A Double-blind, Randomized, Controlled Trial of Air Insufflation Versus Carbon Dioxide Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP).
Status:
COMPLETED
Status Verified Date:
2011-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the safety and efficacy of CO2 insufflations during ERCP
1. Primary objective:
To assess the patient's symptoms, abdominal pain and abdominal distension post procedure (ERCP) in the study group.
2. Secondary objective:
Endoscopist:
* To assess the adequacy of bowel distension for adequate luminal visualization
* To assess the peristaltic movement during the ERCP
Anesthetist:
* 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.
1. Primary objective:
To assess the patient's symptoms, abdominal pain and abdominal distension post procedure (ERCP) in the study group.
2. Secondary objective:
Endoscopist:
* To assess the adequacy of bowel distension for adequate luminal visualization
* To assess the peristaltic movement during the ERCP
Anesthetist:
* 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.
Detailed Description:
mentioned in complete
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: