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

This study has been completed.
Sponsor:
Information provided by:
Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier:
NCT01321203
First received: January 28, 2011
Last updated: July 16, 2011
Last verified: July 2011
History of Changes
  Purpose

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.

Condition
Obstructive Jaundice

Study Type: Observational
Study Design: 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).

Resource links provided by NLM:

MedlinePlus related topics: Endoscopy
U.S. FDA Resources

Further study details as provided by Asian Institute of Gastroenterology, India:

Primary Outcome Measures:
  • Patient comfort post ERCP [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
    the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale )


Secondary Outcome Measures:
  • Abdominal distention prior and post ERCP [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 500
Study Start Date: August 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group-A, use of air;
Group-B use of CO2

Detailed Description:

mentioned in complete

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Study population age group 18yrs and above

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321203

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

No publications provided

Responsible Party: DR A. Saravanan Arjunan, Asian Institute of Gastroenterology, India
ClinicalTrials.gov Identifier: NCT01321203     History of Changes
Other Study ID Numbers: AIG-GI2010-02
Study First Received: January 28, 2011
Last Updated: July 16, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Asian Institute of Gastroenterology, India:
carbon dioxide insufflation

Additional relevant MeSH terms:
Jaundice
Jaundice, Obstructive
Hyperbilirubinemia
 Pathologic Processes
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013