Post-ERCP Acute PancreatitisQIC_ERCPNCT06727851
ESGE-Quality Improvement in Endoscopy: ERCP
An observational study of Post-ERCP Acute Pancreatitis, run by Universität Münster at 1 site in Germany.
Trial summary
The primary aim of the present study is to compare the incidence of post-ERCP pancreatitis (PEP) before and after the implementation of the QIC-guideline in 2017: "Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative". Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-ERCP Acute Pancreatitis
- How many people
- 1,254 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2024to 1 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Individuals eligible for inclusion are patients referred for ERCP who do not fulfill one of the following exclusion criteria * Age under 18 years * Inability to understand information for participation * Refusal of participation, missing cooperativity, e.g., due to age or disease * Pregnant or lactating patients * Patients with > 1 ERCP during the hospital stay: only the initial ERCP will be evaluated
Who may be able to join
None listed.
Who cannot join
- Individuals eligible for inclusion are patients referred for ERCP who do not fulfill one of the following exclusion criteria
- Age under 18 years
- Inability to understand information for participation
- Refusal of participation, missing cooperativity, e.g., due to age or disease
- Pregnant or lactating patients
- Patients with > 1 ERCP during the hospital stay: only the initial ERCP will be evaluated
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site
University of Muenster, Josephs Hospital Warendorf, Academic Teaching Hospital
Warendorf, 48231
About this study
Official title: Quality Improvement in Endoscopy: Has the Implementation of the ESGE Guideline 2017 Led to a Reduction in Post-ERCP Pancreatitis? A Multicenter Trial
The primary aim of the present study is to compare the incidence of post-ERCP pancreatitis (PEP) before and after the implementation of the QIC-guideline in 2017: "Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative".
Read the detailed description
In 2017, a new guideline addressing the quality in ERCP entitled "Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative" was published. The focus of the quality improvement committee (QIC) of the ESGE is to ensure high standard of all endoscopy examinations throughout Europe by adhering to quality-improving factors (key performance indicators and minor performance indicators as defined by the ESGE).
The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Endoscopy (ESGE) will actually lead to an improvement in quality.
The study will compare the quality development in endoscopy based on following time intervals:
- before introduction of the QIC-initiative (before 2017)
- after the introduction of the initiative (2017-2023) (both retrospective data),
- prospectively, from 2024 onwards.
The primary endpoint of this study will be the key performance indicator post-ERCP pancreatitis (PEP). In the ESGE-guideline, a minimum standard of <10% and a target standard of <5% was recommended. Different studies described the incidence of post-ERCP pancreatitis between 3,47% and 10,2%.
The investigators hope that this study will lead to even greater patient safety in the future by improving findings and examination quality and therefore reduce the incidence of post-ERCP pancreatitis. In addition, the aim is to harmonize the high endoscopic standards throughout Europe.
- Conditions
- Post-ERCP Acute Pancreatitis
- Keywords
- performance measures, ESGE, post-ERCP pancreatitis, quality in endoscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group before introduction of the QIC-initiative (before 2017) | The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Gastrointestinal Endoscopy (ESGE) will actually lead to an improvement in quality. The study will compare the quality development in endoscopy based on following time intervals: 1. before introduction of the QIC-initiative (before 2017) 2. after the introduction of the initiative (2017-2023) (both retrospective data) 3. prospectively, from 2024 onwards. The focus of this study we will be the key performance indicator post-ERCP pancreatitis (PEP). In the ESGE-guideline, a minimum standard of <10% and a target standard of <5% was recommended. Different studies described the incidence of post-ERCP pancreatitis between 3,47% and 10,2%. | |
| Group after introduction of the QIC-initiative (2017-2023) | The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Gastrointestinal Endoscopy (ESGE) will actually lead to an improvement in quality. The study will compare the quality development in endoscopy based on following time intervals: 1. before introduction of the QIC-initiative (before 2017) 2. after the introduction of the initiative (2017-2023) (both retrospective data) 3. prospectively, from 2024 onwards. The focus of this study we will be the key performance indicator post-ERCP pancreatitis (PEP). In the ESGE-guideline, a minimum standard of <10% and a target standard of <5% was recommended. Different studies described the incidence of post-ERCP pancreatitis between 3,47% and 10,2%. | |
| Prospective Group | The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Gastrointestinal Endoscopy (ESGE) will actually lead to an improvement in quality. The study will compare the quality development in endoscopy based on following time intervals: 1. before introduction of the QIC-initiative (before 2017) 2. after the introduction of the initiative (2017-2023) (both retrospective data) 3. prospectively, from 2024 onwards. The focus of this study we will be the key performance indicator post-ERCP pancreatitis (PEP). In the ESGE-guideline, a minimum standard of <10% and a target standard of <5% was recommended. Different studies described the incidence of post-ERCP pancreatitis between 3,47% and 10,2%. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-ERCP pancreatitis (PEP)
Comparison of the incidence of PEP before and after the implementation of the guideline. i. Clinical illness with typical pain (physical examination: pain in the upper belly with/without radiation to the back, tenderness when touching the belly) ii. laboratory testing with 3x increase of lipase (or amylase) iii. Characteristic findings in CE-CT, MRI or transabdominal sonography iv. Requiring extension of hospital stay
Measured: 2016 - 2025
Secondary outcomes (4)
Adequate antibiotic prophylaxis before ERCP
Rate of adequate antibiotic prophylaxis before ERCP
Measured: 2016 - 2025
Bile duct cannulation
Rate of successful bile duct cannulation
Measured: 2016 - 2025
Appropriate stent placement in patients with biliary obstruction below the hilum
Rate of appropriate stent placement in patients with biliary obstruction below the hilum
Measured: 2016 - 2025
Bile duct stone extraction
Rate of successful bile duct stone extraction
Measured: 2016 - 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2024
- Study start1 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Post-ERCP Acute PancreatitisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,254 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universität Münster
- Sponsor type
- University, hospital or other
- Collaborators
- University of Kiel, University of Copenhagen, Johannes Gutenberg University Mainz, University Hospital Muenster
- Responsible party
- Sponsor
- Investigators
- Dirk Domagk, MD, Principal investigator, Universität Münster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06727851
- Sponsor's protocol ID
- Quality improvement in ERCP
- Acronym
- QIC_ERCP
- Status last verified
- Nov 2024
- First submitted
- 28 Nov 2024
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Akshintala VS, Kanthasamy K, Bhullar FA, Sperna Weiland CJ, Kamal A, Kochar B, Gurakar M, Ngamruengphong S, Kumbhari V, Brewer-Gutierrez OI, Kalloo AN, Khashab MA, van Geenen EM, Singh VK. Incidence, severity, and mortality of post-ERCP pancreatitis: an updated systematic review and meta-analysis of 145 randomized controlled trials. Gastrointest Endosc. 2023 Jul;98(1):1-6.e12. doi: 10.1016/j.gie.2023.03.023. Epub 2023 Mar 31.
PubMed 37004815Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. doi: 10.1111/j.1572-0241.2007.01279.x. Epub 2007 May 17.
PubMed 17509029Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
PubMed 31863440Domagk D, Oppong KW, Aabakken L, Czako L, Gyokeres T, Manes G, Meier P, Poley JW, Ponchon T, Tringali A, Bellisario C, Minozzi S, Senore C, Bennett C, Bretthauer M, Hassan C, Kaminski MF, Dinis-Ribeiro M, Rees CJ, Spada C, Valori R, Bisschops R, Rutter MD. Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2018 Nov;50(11):1116-1127. doi: 10.1055/a-0749-8767. Epub 2018 Oct 19.
PubMed 30340220
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Improvement in Endoscopy: Has the Implementation of the ESGE Guideline 2017 Led to a Reduction in Post-ERCP Pancreatitis? A Multicenter Trial
- ClinicalTrials.gov ID
- NCT06727851
- Acronym / sponsor ID
- QIC_ERCP / Quality improvement in ERCP
- Conditions
- Post-ERCP Acute Pancreatitis
- Keywords
- performance measures, ESGE, post-ERCP pancreatitis, quality in endoscopy
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,254 participants (estimated)
- Lead sponsor
- Universität MünsterUniversity, hospital or other
- Collaborators
- University of Kiel, University of Copenhagen, Johannes Gutenberg University Mainz, University Hospital Muenster
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 11 Dec 2024 (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 primary aim of the present study is to compare the incidence of post-ERCP pancreatitis (PEP) before and after the implementation of the QIC-guideline in 2017: "Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative".
Detailed description
In 2017, a new guideline addressing the quality in ERCP entitled "Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative" was published. The focus of the quality improvement committee (QIC) of the ESGE is to ensure high standard of all endoscopy examinations throughout Europe by adhering to quality-improving factors (key performance indicators and minor performance indicators as defined by the ESGE).
The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Endoscopy (ESGE) will actually lead to an improvement in quality.
The study will compare the quality development in endoscopy based on following time intervals:
- before introduction of the QIC-initiative (before 2017)
- after the introduction of the initiative (2017-2023) (both retrospective data),
- prospectively, from 2024 onwards.
The primary endpoint of this study will be the key performance indicator post-ERCP pancreatitis (PEP). In the ESGE-guideline, a minimum standard of <10% and a target standard of <5% was recommended. Different studies described the incidence of post-ERCP pancreatitis between 3,47% and 10,2%.
The investigators hope that this study will lead to even greater patient safety in the future by improving findings and examination quality and therefore reduce the incidence of post-ERCP pancreatitis. In addition, the aim is to harmonize the high endoscopic standards throughout Europe.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group before introduction of the QIC-initiative (before 2017) | – | –The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Gastrointestinal Endoscopy (ESGE) will actually lead to an improvement in quality. The study will compare the quality development in endoscopy based on following time intervals: 1. before introduction of the QIC-initiative (before 2017) 2. after the introduction of the initiative (2017-2023) (both retrospective data) 3. prospectively, from 2024 onwards. The focus of this study we will be the key performance indicator post-ERCP pancreatitis (PEP). In the ESGE-guideline, a minimum standard of <10% and a target standard of <5% was recommended. Different studies described the incidence of post-ERCP pancreatitis between 3,47% and 10,2%. |
| Group after introduction of the QIC-initiative (2017-2023) | – | –The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Gastrointestinal Endoscopy (ESGE) will actually lead to an improvement in quality. The study will compare the quality development in endoscopy based on following time intervals: 1. before introduction of the QIC-initiative (before 2017) 2. after the introduction of the initiative (2017-2023) (both retrospective data) 3. prospectively, from 2024 onwards. The focus of this study we will be the key performance indicator post-ERCP pancreatitis (PEP). In the ESGE-guideline, a minimum standard of <10% and a target standard of <5% was recommended. Different studies described the incidence of post-ERCP pancreatitis between 3,47% and 10,2%. |
| Prospective Group | – | –The study shall provide the investigators with information whether the introduction of the quality performance measures adopted by the European Society of Gastrointestinal Endoscopy (ESGE) will actually lead to an improvement in quality. The study will compare the quality development in endoscopy based on following time intervals: 1. before introduction of the QIC-initiative (before 2017) 2. after the introduction of the initiative (2017-2023) (both retrospective data) 3. prospectively, from 2024 onwards. The focus of this study we will be the key performance indicator post-ERCP pancreatitis (PEP). In the ESGE-guideline, a minimum standard of <10% and a target standard of <5% was recommended. Different studies described the incidence of post-ERCP pancreatitis between 3,47% and 10,2%. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals eligible for inclusion are patients referred for ERCP who do not fulfill one of the following exclusion criteria * Age under 18 years * Inability to understand information for participation * Refusal of participation, missing cooperativity, e.g., due to age or disease * Pregnant or lactating patients * Patients with > 1 ERCP during the hospital stay: only the initial ERCP will be evaluated
Key inclusion criteria (0 listed)
Key exclusion criteria (7 listed)
- Individuals eligible for inclusion are patients referred for ERCP who do not fulfill one of the following exclusion criteria
- Age under 18 years
- Inability to understand information for participation
- Refusal of participation, missing cooperativity, e.g., due to age or disease
- Pregnant or lactating patients
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
Post-ERCP pancreatitis (PEP)
Time frame: 2016 - 2025
Comparison of the incidence of PEP before and after the implementation of the guideline. i. Clinical illness with typical pain (physical examination: pain in the upper belly with/without radiation to the back, tenderness when touching the belly) ii. laboratory testing with 3x increase of lipase (or amylase) iii. Characteristic findings in CE-CT, MRI or transabdominal sonography iv. Requiring extension of hospital stay
4 secondary outcomes
Adequate antibiotic prophylaxis before ERCP
Time frame: 2016 - 2025
Bile duct cannulation
Time frame: 2016 - 2025
Appropriate stent placement in patients with biliary obstruction below the hilum
Time frame: 2016 - 2025
Bile duct stone extraction
Time frame: 2016 - 2025
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Background: PubMed 37004815Akshintala VS, Kanthasamy K, Bhullar FA, Sperna Weiland CJ, Kamal A, Kochar B, Gurakar M, Ngamruengphong S, Kumbhari V, Brewer-Gutierrez OI, Kalloo AN, Khashab MA, van Geenen EM, Singh VK. Incidence, severity, and mortality of post-ERCP pancreatitis: an updated systematic review and meta-analysis of 145 randomized controlled trials. Gastrointest Endosc. 2023 Jul;98(1):1-6.e12. doi: 10.1016/j.gie.2023.03.023. Epub 2023 Mar 31.
- Background: PubMed 17509029Andriulli A, Loperfido S, Napolitano G, Niro G, Valvano MR, Spirito F, Pilotto A, Forlano R. Incidence rates of post-ERCP complications: a systematic survey of prospective studies. Am J Gastroenterol. 2007 Aug;102(8):1781-8. doi: 10.1111/j.1572-0241.2007.01279.x. Epub 2007 May 17.
- Background: PubMed 31863440Dumonceau JM, Kapral C, Aabakken L, Papanikolaou IS, Tringali A, Vanbiervliet G, Beyna T, Dinis-Ribeiro M, Hritz I, Mariani A, Paspatis G, Radaelli F, Lakhtakia S, Veitch AM, van Hooft JE. ERCP-related adverse events: European Society of Gastrointestinal Endoscopy (ESGE) Guideline. Endoscopy. 2020 Feb;52(2):127-149. doi: 10.1055/a-1075-4080. Epub 2019 Dec 20.
- Background: PubMed 30340220Domagk D, Oppong KW, Aabakken L, Czako L, Gyokeres T, Manes G, Meier P, Poley JW, Ponchon T, Tringali A, Bellisario C, Minozzi S, Senore C, Bennett C, Bretthauer M, Hassan C, Kaminski MF, Dinis-Ribeiro M, Rees CJ, Spada C, Valori R, Bisschops R, Rutter MD. Performance measures for ERCP and endoscopic ultrasound: a European Society of Gastrointestinal Endoscopy (ESGE) Quality Improvement Initiative. Endoscopy. 2018 Nov;50(11):1116-1127. doi: 10.1055/a-0749-8767. Epub 2018 Oct 19.
- Individual participant dataSharing planned: Undecided
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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.
Dirk Domagk, MD principal investigator
Universität Münster
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 Post-ERCP Acute Pancreatitis, run by Universität Münster at 1 site in Germany.
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 0 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 11 Dec 2024. 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 Germany. 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?
This study is still under way. Results are not available in the source record yet.
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?
Post-ERCP pancreatitis (PEP) (time frame: 2016 - 2025). 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 NCT06727851, which also lists 4 linked publications.
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 11 Dec 2024.