Cholangiopancreatography, Endoscopic RetrogradeNCT02983331
Mortality After Endoscopic Retrograde Cholangiopancreatography
An observational study of Cholangiopancreatography, Endoscopic Retrograde and Mortality, run by Gulsah Karaoren at 1 site in Turkey (Türkiye).
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 Read more about this study
- Who is it for?
- Ages 42 to 90 years
- Conditions the study is for
- Cholangiopancreatography, Endoscopic Retrograde, Mortality, Deep Sedation
- What is being tested?
- complications during procedure
- Type of treatment
- Surgery or procedure
- How many people
- 1,471 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Apr 2016to May 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 42 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Patients who underwent elective or emergent ERCP at semi-prone position with routine monitoring and standard sedation protocol
Who cannot join
- Patients who discharged to ward after treatment and follow-up in ICU
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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.
- Being tested
- complications during procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
complications during procedureProcedure or surgery
patients may have anesthesia related complications during procedure
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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).
Measured: 5 years
Secondary outcomes (2)
Value of Acute Physiology and Chronic Health Evaluation (APACHE II) score for predicting mortality
Measured: 5 years
Value of Charlson comorbidity index (CCI) score for predicting mortality
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startApr 2016
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholangiopancreatography, Endoscopic RetrogradeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Retrospective
- Enrolment
- 1,471 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gulsah Karaoren
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Gulsah Karaoren, Umraniye Education and Research Hospital
- Investigators
- Gulsah Karaoren, MD, Principal investigator, Umraniye Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983331
- Sponsor's protocol ID
- GK11
- Status last verified
- Dec 2016
- First submitted
- 27 Nov 2016
- Last updated
- 6 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.
Publications
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.
PubMed 24714755
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patients With Mortality After Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT02983331
- Acronym / sponsor ID
- GK11
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,471 participants (actual)
- Lead sponsor
- Gulsah KaraorenOther government
- Study start
- Apr 2016
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Time perspective
- Retrospective
Who may qualify
- Ages
- 42 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Patients who underwent elective or emergent ERCP at semi-prone position with routine monitoring and standard sedation protocol
Key exclusion criteria (1 listed)
- Patients who discharged to ward after treatment and follow-up in ICU
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| complications during procedurepatients may have anesthesia related complications during procedure | Procedure or surgery | – |
Primary outcome
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
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).
2 secondary outcomes
Value of Acute Physiology and Chronic Health Evaluation (APACHE II) score for predicting mortality
Time frame: 5 years
Value of Charlson comorbidity index (CCI) score for predicting mortality
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2016.
- Results publication: PubMed 24714755Katsinelos 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.
- Individual participant dataSharing planned: Yes. The datasets used and/or analysed during the current study available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gulsah Karaoren, MD principal investigator
Umraniye Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cholangiopancreatography, Endoscopic Retrograde and Mortality, run by Gulsah Karaoren at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With endoscopic retrograde cholangiopancreatography Related complications (time frame: 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02983331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2016.