MedDataX Logo

Mortality After Endoscopic Retrograde Cholangiopancreatography

NCT ID: NCT02983331

Last Updated: 2016-12-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1471 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-04-30

Study Completion Date

2016-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholangiopancreatography, Endoscopic Retrograde Mortality Deep Sedation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

complications during procedure

patients may have anesthesia related complications during procedure

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

42 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gulsah Karaoren

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gulsah Karaoren

MD

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gulsah Karaoren, MD

Role: PRINCIPAL_INVESTIGATOR

Umraniye Research Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Istanbul Umraniye Training Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 24714755 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GK11

Identifier Type: -

Identifier Source: org_study_id