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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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, Obstructive
Jaundice
Hyperbilirubinemia
Pathologic Processes
Skin Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on October 01, 2014