Mortality After Endoscopic Retrograde Cholangiopancreatography

December 1, 2016 updated by: Gulsah Karaoren

Patients With 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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

1471

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul Umraniye Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

42 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

We retrospectively reviewed 1471 patients who underwent elective or emergent ERCP 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
5 years
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).
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Value of Acute Physiology and Chronic Health Evaluation (APACHE II) score for predicting mortality
Time Frame: 5 years
5 years
Value of Charlson comorbidity index (CCI) score for predicting mortality
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gulsah Karaoren

Investigators

  • Principal Investigator: Gulsah Karaoren, MD, Umraniye Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

May 1, 2016

Study Completion (ACTUAL)

May 1, 2016

Study Registration Dates

First Submitted

November 27, 2016

First Submitted That Met QC Criteria

December 1, 2016

First Posted (ESTIMATE)

December 6, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

December 6, 2016

Last Update Submitted That Met QC Criteria

December 1, 2016

Last Verified

December 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • GK11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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