Mortality After Endoscopic Retrograde Cholangiopancreatography

• Sponsor: Gulsah Karaoren (Other)
• Overall Status: Completed
• CT.gov ID: NCT02983331
• Collaborator: (none)
• Enrollment: 1,471
• Location: 1
• Duration (Days): 30
• Patients Per Site Per Month: 1492.5

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Cholangiopancreatography, Endoscopic Retrograde; Mortality; Deep Sedation	Procedure: complications during procedure

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 Design

• Study Type: Observational
• Actual Enrollment: 1471 participants
• Time Perspective: Retrospective
• Official Title: Patients With Mortality After Endoscopic Retrograde Cholangiopancreatography
• Study Start Date: Apr 1, 2016
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Outcome Measures

Primary Outcome Measures

1. Number of Participants With endoscopic retrograde cholangiopancreatography Related complications [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 [5 years]

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

Secondary Outcome Measures

1. Value of Acute Physiology and Chronic Health Evaluation (APACHE II) score for predicting mortality [5 years]

2. Value of Charlson comorbidity index (CCI) score for predicting mortality [5 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 42 Years to 90 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Umraniye Training Hospital	Istanbul		Turkey

Sponsors and Collaborators

• Gulsah Karaoren

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gulsah Karaoren, MD, Umraniye Education and Research Hospital
• ClinicalTrials.gov Identifier: NCT02983331
• Other Study ID Numbers: GK11
• First Posted: Dec 6, 2016
• Last Update Posted: Dec 6, 2016
• Last Verified: Dec 1, 2016

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes

Study Results

No Results Posted as of Dec 6, 2016