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Clinical Trials/NCT01321203
NCT01321203
Completed
Not Applicable

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

Asian Institute of Gastroenterology, India1 site in 1 country500 target enrollmentAugust 2010
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ConditionsObstructive Jaundice

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Obstructive Jaundice
Sponsor
Asian Institute of Gastroenterology, India
Enrollment
500
Locations
1
Primary Endpoint
Patient comfort post ERCP
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
March 2011
Last Updated
14 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Asian Institute of Gastroenterology, India

Eligibility 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.

Outcomes

Primary Outcomes

Patient comfort post ERCP

Time Frame: 1 hour

the pain score measures using Visual Analog scale (VAs - 1 to 10 cm scale )

Secondary Outcomes

  • Abdominal distention prior and post ERCP(5 minutes)

Study Sites (1)

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