ERCP, Failure, Complications, CannulationNCT04818567
Frequency and Causes of Failed Endoscopic Retrograde Cholangio-Pancreatography in AL-Rajhi Endoscopy Unit
An observational study of ERCP, Failure, Complications, Cannulation, run by Assiut University.
Trial summary
The failure can be traced backed to operator causes, technical causes and patient causes. the most common etiology is cannulation failure. ERCP complications includes post-ERCP pancreatitis, perforation, bleeding, cholangitis and cholecystitis. Read more about this study
- Who is it for?
- Ages 6 to 80 years
- Conditions the study is for
- ERCP, Failure, Complications, Cannulation
- How many people
- 196 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2021to 30 May 2022
- 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 6 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All cases underwent ERCP in our center
Who may be able to join
- All cases underwent ERCP in our center from 1st of January, 2013 to 1st of January. 2021 with any causes of jaundice or any indication for which ERCP was done.
Who cannot join
- incomplete data or missing files were excluded from this study
About this study
The failure can be traced backed to operator causes, technical causes and patient causes.
the most common etiology is cannulation failure. ERCP complications includes post-ERCP pancreatitis, perforation, bleeding, cholangitis and cholecystitis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and causes of failed Endoscopic Retrograde Cholangio-Pancreatography in AL-Rajhi endoscopy unit
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ERCP, Failure, Complications, CannulationStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 196 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Soha Mohie El Din Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818567
- Sponsor's protocol ID
- ERCP failure
- Status last verified
- Jul 2021
- First submitted
- 24 Mar 2021
- Last updated
- 29 Jul 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Causes of Failed Endoscopic Retrograde Cholangio-Pancreatography in AL-Rajhi Endoscopy Unit
- ClinicalTrials.gov ID
- NCT04818567
- Acronym / sponsor ID
- ERCP failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 196 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 26 Mar 2021 (actual)
- 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.
The failure can be traced backed to operator causes, technical causes and patient causes.
the most common etiology is cannulation failure. ERCP complications includes post-ERCP pancreatitis, perforation, bleeding, cholangitis and cholecystitis.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All cases underwent ERCP in our center
Key inclusion criteria (1 listed)
- All cases underwent ERCP in our center from 1st of January, 2013 to 1st of January. 2021 with any causes of jaundice or any indication for which ERCP was done.
Key exclusion criteria (1 listed)
- incomplete data or missing files were excluded from this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Frequency and causes of failed Endoscopic Retrograde Cholangio-Pancreatography in AL-Rajhi endoscopy unit
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2021.
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of ERCP, Failure, Complications, Cannulation, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 29 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Frequency and causes of failed Endoscopic Retrograde Cholangio-Pancreatography in AL-Rajhi endoscopy unit (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2021.