Biliary DiseaseNCT04705740
Influence of the Endoscopists and Endoscopic Retrograde CholangioPanceratography
An observational study of Biliary Disease and Pancreatic Diseases, run by Fundacion Miguel Servet at 1 site in Spain.
Trial summary
Retrospective analysis on a prospective database that analyzes the influence of the number of endoscopists on the Endoscopic Retrograde CholangioPanceratography result. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Disease, Pancreatic Diseases
- What is being tested?
- ERCP
- How many people
- 2,561 participants
- Where
- 1 siteSpain
- Study dates
- 1 Sep 2020to 31 Oct 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients over 18 years of age, undergoing ERCP by the staff allocated in the endoscopy unit.
Who may be able to join
- patients undergoing ERCP with written informed consent given
- Staff allocated in the endoscopy unit
Who cannot join
- Rejection to participate in the study
- ERCP procedures performed by fellows in training
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of the Endoscopist Case Volumen on Endoscopic Retrograde CholangioPanceratography Outcomes
Retrospective analysis on a prospective database that analyzes the influence of the number of endoscopists on the Endoscopic Retrograde CholangioPanceratography result.
Read the detailed description
The number of Endoscopic Retrograde CholangioPanceratographys (ERCP) performed annually by an endoscopist has been shown to influence the outcomes of the procedure, especially on the papillary cannulation rate and the adverse effects rate. The number of ERCPs performed annually by each endoscopist is directly related to the number of endoscopists who perform this procedure, since the total number of ERCPs performed annually at each center is usually constant.
The hypothesis of this study is that the number of endoscopists who perform ERCP in a hospital influences the results of the procedure, so that the fewer the number of endoscopists the better the results.
To evaluate this hypothesis, the investigators have designed a retrospective study analyzing data from a prospectively filled database, which includes all ERCPs performed in our center from September 2013 to June 2020. For organizative reasons unrelated to the endoscopy unit, in the center it has beed progressively reduced the number of endoscopists who perform ERCP, starting from 5 endoscopists at the beginning of the study to 3 endoscopists at the end of the study inclusion period. In fact, three different periods of similar duration can be distinguished: September 2013 to August 2015 (5 endoscopists), September 2015 to December 2017 (4 endoscopists) and January 2018 to June 2020 (3 endoscopists).
The outcomes obtained with ERCP in these three periods will be analyzed and compared, assessing the cannulation rate and the adverse effects rate as the main comparison parameters.
- Conditions
- Biliary Disease, Pancreatic Diseases
- Being tested
- ERCP
- Keywords
- ERCP, endoscopy, gastrointestinal, choledocholithiasis, Endoscopic Retrograde CholangioPanceratography
- Medical subject headings
- Gallbladder Diseases, Pancreatic Diseases, Choledocholithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCPOther
ERCPs performed annually by an endoscopist
| Study group | Role | What they receive |
|---|---|---|
| September 2013 to August 2015 | 5 endoscopists Receives: Other: ERCP | |
| September 2015 to December 2017 | 4 endoscopists Receives: Other: ERCP | |
| January 2018 to June 2020 | 3 endoscopists Receives: Other: ERCP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Papillary cannulation
Rate of papillary cannulation.Success in achieving transpapillary access to the bile duct.It has to be confirmed fluoroscopically
Measured: During the procedure
Adverse effects
Rate of adverse effect assessed by the ASGE classification
Measured: Up to 1 month after intervention
Secondary outcomes (3)
Individual adverse effects
Rate of individual adverse effect during the intervention
Measured: Up to 1 month after intervention
Complexity level of ERCP
Complexity level of ERCP according to ASGE classification of complexity of the endoscopic procedures
Measured: During the ERCP procedure
Therapeutics performed with ERCP
Techniques used during ERCP
Measured: During the ERCP procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2021
- Study start1 Sep 2020
- Primary completion30 Sep 2020
- Study completion31 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary DiseaseStudies 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
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 2,561 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion Miguel Servet
- Sponsor type
- University, hospital or other
- Collaborators
- Complejo Hospitalario de Navarra
- Responsible party
- Sponsor
- Investigators
- Juan J Vila, PhD, Principal investigator, Complejo Hospitalario de Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04705740
- Sponsor's protocol ID
- NER20
- Status last verified
- Jan 2021
- First submitted
- 11 Dec 2020
- Last updated
- 12 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of the Endoscopist Case Volumen on Endoscopic Retrograde CholangioPanceratography Outcomes
- ClinicalTrials.gov ID
- NCT04705740
- Acronym / sponsor ID
- NER20
- Conditions
- Biliary Disease, Pancreatic Diseases
- Keywords
- ERCP, endoscopy, gastrointestinal, choledocholithiasis, Endoscopic Retrograde CholangioPanceratography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,561 participants (actual)
- Lead sponsor
- Fundacion Miguel ServetUniversity, hospital or other
- Collaborators
- Complejo Hospitalario de Navarra
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Oct 2020 (actual)
- First posted
- 12 Jan 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.
Retrospective analysis on a prospective database that analyzes the influence of the number of endoscopists on the Endoscopic Retrograde CholangioPanceratography result.
Detailed description
The number of Endoscopic Retrograde CholangioPanceratographys (ERCP) performed annually by an endoscopist has been shown to influence the outcomes of the procedure, especially on the papillary cannulation rate and the adverse effects rate. The number of ERCPs performed annually by each endoscopist is directly related to the number of endoscopists who perform this procedure, since the total number of ERCPs performed annually at each center is usually constant.
The hypothesis of this study is that the number of endoscopists who perform ERCP in a hospital influences the results of the procedure, so that the fewer the number of endoscopists the better the results.
To evaluate this hypothesis, the investigators have designed a retrospective study analyzing data from a prospectively filled database, which includes all ERCPs performed in our center from September 2013 to June 2020. For organizative reasons unrelated to the endoscopy unit, in the center it has beed progressively reduced the number of endoscopists who perform ERCP, starting from 5 endoscopists at the beginning of the study to 3 endoscopists at the end of the study inclusion period. In fact, three different periods of similar duration can be distinguished: September 2013 to August 2015 (5 endoscopists), September 2015 to December 2017 (4 endoscopists) and January 2018 to June 2020 (3 endoscopists).
The outcomes obtained with ERCP in these three periods will be analyzed and compared, assessing the cannulation rate and the adverse effects rate as the main comparison parameters.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| September 2013 to August 2015 | – | Other: ERCP5 endoscopists |
| September 2015 to December 2017 | – | Other: ERCP4 endoscopists |
| January 2018 to June 2020 | – | Other: ERCP3 endoscopists |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years of age, undergoing ERCP by the staff allocated in the endoscopy unit.
Key inclusion criteria (2 listed)
- patients undergoing ERCP with written informed consent given
- Staff allocated in the endoscopy unit
Key exclusion criteria (2 listed)
- Rejection to participate in the study
- ERCP procedures performed by fellows in training
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 |
|---|---|---|
| ERCPERCPs performed annually by an endoscopist | Other | January 2018 to June 2020, September 2013 to August 2015, September 2015 to December 2017 |
Primary outcome
Papillary cannulation
Time frame: During the procedure
Rate of papillary cannulation.Success in achieving transpapillary access to the bile duct.It has to be confirmed fluoroscopically
Adverse effects
Time frame: Up to 1 month after intervention
Rate of adverse effect assessed by the ASGE classification
3 secondary outcomes
Individual adverse effects
Time frame: Up to 1 month after intervention
Complexity level of ERCP
Time frame: During the ERCP procedure
Therapeutics performed with ERCP
Time frame: During the ERCP procedure
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 12 Jan 2021.
- Individual participant dataSharing planned: No
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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.
Juan J Vila, PhD principal investigator
Complejo Hospitalario de Navarra
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 Biliary Disease and Pancreatic Diseases, run by Fundacion Miguel Servet at 1 site in Spain.
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 2 inclusion and 2 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 12 Jan 2021. 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 Spain. 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?
Papillary cannulation (time frame: During the procedure). 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?
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 12 Jan 2021.