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

A

Asian Institute of Gastroenterology, India

Status

Completed

Conditions

Obstructive Jaundice

Study type

Observational

Funder types

Other

Identifiers

NCT01321203
AIG-GI2010-02

Details and patient eligibility

About

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.

Full description

mentioned in complete

Enrollment

500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

500 participants in 2 patient groups

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

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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