Mortality After Endoscopic Retrograde Cholangiopancreatography

Mortality Clinical Trial

Official title:

Patients With Mortality After Endoscopic Retrograde Cholangiopancreatography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983331
• Other study ID #: GK11
• Status: Completed
• Phase: N/A
• First received: November 27, 2016
• Last updated: December 1, 2016
• Start date: April 2016
• Est. completion date: May 2016

Study information

• Verified date: December 2016
• Source: Umraniye Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1471
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 42 Years to 90 Years

Eligibility

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 Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cholangiopancreatography, Endoscopic Retrograde
• Deep Sedation
• Mortality

Intervention

Procedure:
• complications during procedure
patients may have anesthesia related complications during procedure

Locations

Country	Name	City	State
Turkey	Istanbul Umraniye Training Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Gulsah Karaoren

Country where clinical trial is conducted

Turkey, 

References & 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 endoscopis — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Value of Acute Physiology and Chronic Health Evaluation (APACHE II) score for predicting mortality		5 years	No
Secondary	Value of Charlson comorbidity index (CCI) score for predicting mortality		5 years	No