Outcome of Carbon Dioxide Versus Air Insufflations During Endoscopic Retrograde Cholangiopancreatography (ERCP)

Completed

• Conditions: Obstructive Jaundice

• Registration Number: NCT01321203
• Lead Sponsor: Asian Institute of Gastroenterology, India

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.

Detailed Description

mentioned in complete

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2011-01-28
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-16
• Last Update Posted: 2011-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• All consecutive adult patients referred for ERCP to AIG Hyderabad

Exclusion Criteria

• Age < 18 years old excluded from the study.
• Patients with COPD.
• Patients with poor ejection fractions and decompensated heart failure.
• Patients with acute illness that require emergency ERCP and not fit for pre procedure and post procedure assessments.
• Patients with recent endoscopic procedure within 24 hours.
• Patient with history of recent surgery within 7 days of duration.
• Pregnant patients.
• Patients not keen to give consent for the study.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patient comfort post ERCP	1 hour	the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale )

Secondary Outcome Measures

Name	Time	Method
Abdominal distention prior and post ERCP	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.

Trial Locations

Locations (1)

Asian Institute Of Gastroenterology India; 🇮🇳 Hyderabad, Andra Pradesh, India