Mortality After Endoscopic Retrograde Cholangiopancreatography

NCT02983331 | Completed

• 1 other identifier: GK11
• Study Type: observational
• Target: 1,471
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cholangiopancreatography, Endoscopic Retrograde; Mortality; Deep Sedation

Outcome Measures

Primary Outcomes (2)

• Number of Participants With endoscopic retrograde cholangiopancreatography Related complications

  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

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

  5 years

Secondary Outcomes (2)

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

  5 years

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

  5 years

Interventions

complications during procedure PROCEDURE

patients may have anesthesia related complications during procedure

Eligibility Criteria

• Age: 42 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Gulsah Karaoren: lead

Study Sites (1)

Istanbul Umraniye Training Hospital

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

• Katsinelos P, Lazaraki G, Chatzimavroudis G, Gkagkalis S, Vasiliadis I, Papaeuthimiou A, Terzoudis S, Pilpilidis I, Zavos C, Kountouras J. Risk factors for therapeutic ERCP-related complications: an analysis of 2,715 cases performed by a single endoscopist. Ann Gastroenterol. 2014;27(1):65-72.

  PMID: 24714755 RESULT

Study Officials

• Gulsah Karaoren, MD

  Umraniye Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: November 27, 2016
• First Posted: December 6, 2016
• Study Start: April 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: December 6, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)