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Completed

NCT Number: NCT02983331

Mortality After Endoscopic Retrograde Cholangiopancreatography

In this study, the investigators aimed to overview patients with specific and non-specific complications who admitted to intensive care unit following endoscopic retrograde cholangiopancreatography and had fatal course in the facility

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Key information

Age range

42 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul Umraniye Training Hospital

Istanbul, Turkey (Türkiye)

About this study

The investigators retrospectively reviewed patients who underwent elective or emergent endoscopic retrograde cholangiopancreatography at semi-prone position under pharyngeal anesthesia (lidocaine spray) with routine monitoring (including electrocardiography, non-invasive blood pressure, peripheral capillary oxygen saturation) and standard sedation protocol (midazolam 0.02 mgkg-1; fentanyl, 1 mgkg-1; propofol 1 mgkg-1) between 2011 and 2016 after approval of local ethics committee of Umraniye Training Hospital.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who underwent elective or emergent ERCP at semi-prone position with routine monitoring and standard sedation protocol

Exclusion criteria

  • Patients who discharged to ward after treatment and follow-up in ICU

Treatment and study plan

complications during procedure

Procedure

patients may have anesthesia related complications during procedure

Primary outcomes

  1. Number of Participants With endoscopic retrograde cholangiopancreatography Related complications

    Time frame: 5 years

    We retrospectively reviewed patients who underwent elective or emergent endoscopic retrograde cholangiopancreatography at semi-prone position under pharyngeal anesthesia (lidocaine spray) with routine monitoring (including electrocardiography, non-invasive blood pressure, peripheral capillary oxygen saturation) and standard sedation protocol

  2. Rate of anaesthesia related mortality of the endoscopic retrograde cholangiopancreatographyprocedure under sedation

    Time frame: 5 years

    We identified patients who developed complications during procedure and admitted to intensive care unit (ICU).

Secondary outcomes

  1. Value of Acute Physiology and Chronic Health Evaluation (APACHE II) score for predicting mortality

    Time frame: 5 years

  2. Value of Charlson comorbidity index (CCI) score for predicting mortality

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Gulsah Karaoren

Other Gov

Registry information

Official study title

Patients With Mortality After Endoscopic Retrograde Cholangiopancreatography

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Dec 6, 2016
Registry last updated
Dec 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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