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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01321203
Recruitment Status : Completed
First Posted : March 23, 2011
Last Update Posted : July 19, 2011
Information provided by:
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:


  • 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
Obstructive Jaundice

Detailed Description:
mentioned in complete

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case Control
Time Perspective: Prospective
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
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Group-A, use of air;
Group-B use of CO2

Primary Outcome Measures :
  1. Patient comfort post ERCP [ Time Frame: 1 hour ]
    the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale )

Secondary Outcome Measures :
  1. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Study population age group 18yrs and above

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01321203

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Asian Institute Of Gastroenterology India
Hyderabad, Andra Pradesh, India, 500082
Sponsors and Collaborators
Asian Institute of Gastroenterology, India
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Principal Investigator: Saravanan Arjuanan, MD Asian Institute of Gastroenterology, India

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Responsible Party: DR A. Saravanan Arjunan, Asian Institute of Gastroenterology, India Identifier: NCT01321203     History of Changes
Other Study ID Numbers: AIG-GI2010-02
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011
Keywords provided by Asian Institute of Gastroenterology, India:
carbon dioxide insufflation
Additional relevant MeSH terms:
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Jaundice, Obstructive
Pathologic Processes
Skin Manifestations
Signs and Symptoms