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

Obstructive Jaundice Clinical Trial

Official title:

A Double-blind, Randomized, Controlled Trial of Air Insufflation Versus Carbon Dioxide Insufflation During Endoscopic Retrograde Cholangiopancreatography (ERCP).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321203
• Other study ID #: AIG-GI2010-02
• Status: Completed
• Phase: N/A
• First received: January 28, 2011
• Last updated: July 16, 2011
• Start date: August 2010
• Est. completion date: March 2011

Study information

• Verified date: July 2011
• Source: Asian Institute of Gastroenterology, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

mentioned in complete

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Jaundice, Obstructive
• Obstructive Jaundice

Locations

Country	Name	City	State
India	Asian Institute Of Gastroenterology India	Hyderabad	Andra Pradesh

Sponsors (1)

Lead Sponsor	Collaborator
Asian Institute of Gastroenterology, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient comfort post ERCP	the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale )	1 hour	No
Secondary	Abdominal distention prior and post ERCP	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.	5 minutes	No