CholedocholithiasisNCT06670547
Spanish Registry of Quality Indicators and Adverse Events of Endoscopic Retrograde Cholangiopancreatography
An observational study of Choledocholithiasis and Choledocholithiasis With Acute Cholangitis, run by Germans Trias i Pujol Hospital.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) is a technique which combines endoscopic and radiological vision and allows for therapeutic procedures on pathologies of the pancreas and bile duct. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Choledocholithiasis, Choledocholithiasis With Acute Cholangitis, Cholangiocarcinoma
- What is being tested?
- Endoscopic retrograde cholangiopancreatography (ERCP)
- Type of treatment
- Surgery or procedure
- How many people
- 3,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 30 Oct 2028
- How long will I take part?
- 30 Days
- 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: Patients with biliopancreatic pathology for whom ERCP is performed in hospitals in Spain.
Who may be able to join
- All consecutive patients who have undergone an ERCP at participating centres from 1 November 2024 will be included. An ERCP will be considered to have been performed when an endoscope is introduced to access the duodenal papilla.
- These included patients must meet all of the following criteria:
- Over 18 years of age
- Signed informed consent.
Who cannot join
- Under 18 years of age
- Unavailability of informed consent
- Impossibility of follow-up.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective and Multicenter Spanish Registry of Quality Indicators and Adverse Events of Endoscopic Retrograde Cholangiopancreatography
Endoscopic retrograde cholangiopancreatography (ERCP) is a technique which combines endoscopic and radiological vision and allows for therapeutic procedures on pathologies of the pancreas and bile duct.
ERCP is a generally well tolerated procedure, nonetheless it is a complex technique that has a higher frequency of complications compared to most endoscopic procedures that can even be life-threatening. These complications are related to patient characteristics, experience of the endoscopist performing the procedure, and specific factors to the technique. Due to its complexity, quality assurance, operator training and auditing are required to increase success and minimize complications.
Read more
There are quality indicators suggested by the main scientific societies in relation to technical aspects and complications, recommending their monitoring and auditing. Most endoscopy units lack records to monitor quality and complications, which prevents the assessment of quality and the identification of areas for improvement.
Given the lack of evidence of the quality of ERCP in the Spanish population, the investigators will be conducting a multicenter, national prospective study that will include subjects who undergo ERCP.
Patient data and technical aspects of the procedure will be recorded and all included patients will be monitored to identify complications. The quality indicators obtained within the registry will be compared with those established by scientific societies and the relationship between complications and technical factors will be analyzed.
Read the detailed description
Currently, endoscopic retrograde cholangiopancreatography (ERCP) is a well-established procedure that is in continuous development, with an incidence and severity of adverse events (AEs) that differ substantially from those related to other endoscopic procedures, reaching up to 14.7% and with a mortality rate of 0.7%, even in expert centers 1. For this reason, it is essential to ensure the quality of ERCP procedures, requiring optimal training, capacity building and auditing to increase the success of the procedure and minimize the risk of complications 2.
In recent years, the evaluation of the quality of ERCP has gained interest among health professionals and patient organizations. In 2018, the European Society of Gastrointestinal Endoscopy (ESGE) and the United European Gastroenterology (UEG) published key quality recommendations for ERCP and endoscopic ultrasonography with the aim of encouraging healthcare professionals to implement these performance targets at national level 3. For ERCP there are 5 recommendations including adequate antibiotic prophylaxis before ERCP (at least 90%), biliary cannulation rate (at least 90%), adequate stent placement in patients with sub-hilum obstruction (at least 95%), removal of bile duct stones (at least 90%) and post-ERCP pancreatitis (less than 10%).
Following this line, endoscopists in the Netherlands have been using a mandatory nationwide quality register since 2016 (Trans.IT database; Rotterdam, the Netherlands), which provides information on the quality of ERCP 4. They have recently published the analysis of this register in relation to the ESGE quality recommendations. 5671 procedures performed by 57 endoscopists in 11 centres were included. Three key quality indicators were met: successful biliary cannulation, adequate placement of stents for biliary obstruction and removal of bile duct stones with a high overall success rate. These robust data from routine clinical practice also allow us to identify areas for improving the quality of ERCP, for example, successful cannulation of native papillae below 90% for endoscopists performing fewer than 50 procedures per year or the rate of adequate placement of biliary stents below 90% in endoscopists performing fewer than 25 procedures per year 5. Unfortunately, the rate of pancreatitis, which is the most appropriate indicator of the rate of adverse events, was not evaluated in this registry.
In our view, the collection of data at a national level is of undoubted value to identify areas for improvement and to guarantee quality in ERCP, however, there are no state databases in our setting.
The present study aims to evaluate the quality indicators of ERCP recommended by the ESGE-UEG in a Spanish prospective registry and to describe the real incidence of adverse events in clinical practice, and their association with technical aspects of the procedure.
- Conditions
- Choledocholithiasis, Choledocholithiasis With Acute Cholangitis, Cholangiocarcinoma, Sclerosing Cholangitis, Pancreatic Cancer Resectable, Pancreatic Cancer Non-resectable
- Being tested
- Endoscopic retrograde cholangiopancreatography (ERCP)
- Keywords
- ERCP ADVERSE EVENTS, PERFORMANCE MEASURES
- Medical subject headings
- Choledocholithiasis, Cholangiocarcinoma, Cholangitis, Sclerosing, Biliary Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic retrograde cholangiopancreatography (ERCP)Procedure or surgery
Endoscopic retrograde cholangiopancreatography (ERCP)
| Study group | Role | What they receive |
|---|---|---|
| Patients with biliopancreatic pathology undergoing ERCP | Patients with biliopancreatic pathology who undergo ERCP are over 18 years of age and sign the informed consent. Receives: Procedure: Endoscopic retrograde cholangiopancreatography (ERCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry
Number of participants receiving adequate antibiotic prophylaxis before ERCP.
Measured: Patients receiving antibiotic prophylaxis of at least one dose of any systemic antibiotic in a 12-hour interval prior to ERCP.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
Number of participants who achieved biliary cannulation.
Measured: Patients in whom biliary cannulation is achieved up to 1 hour after completion of ERCP.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
Number of participants in whom stents are successfully placed in obstructions distal to the hilum.
Measured: Patients who successfully placed stents in obstructions distal to the hilum up to 1 hour after completion of ERCP.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
Number of participants with successful removal of biliary tract stones.
Measured: Patients who successfully removed bile duct stones up to 1 hour after completion of ERCP.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
Number of participants developing post-ERCP pancreatitis.
Measured: Patients who developed acute pancreatitis at 7 and 30 days after ERCP.
Secondary outcomes (1)
To describe the severity of adverse events in ERCP according to the AGREE classification and their association with technical aspects of the procedure
Number adverse event (AE)A telephone contact with general practitioner, outpatient clinic, or endoscopy service without any intervention or extended observation of the patient after the procedure (3 hours without any intervention)
Grade I AE with any deviation of the standard post-procedural course, without pharmacologic treatment or endoscopic, radiologic, or surgical interventions, Hospital admission (24 hours), without any intervention, Allowed therapeutic regimens are antiemetics, antipyretics, analgesics and electrolytes or Allowed diagnostic radiology and laboratory tests
Grade II AE requiring pharmacologic treatment with drugs other than those allowed for grade I AE or Blood product transfusions or Hospital admission for more than 24 hours
Grade Illa AE requiring endoscopic or radiologic intervention Grade Illb Surgical intervention
Grade IV AE requiring intensive care unit IVa Single-organ dysfunction including dialysis IVb Multiorgan dysfunction Grade V Death of patient
Measured: Assessment of the development of adverse events at 24 hours according to the practice of each hospital; at 7 days and at 30 days after performing the ERCP by telephone call.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start1 Nov 2024 (estimated)
- Primary completion30 Oct 2025 (estimated)
- Study completion30 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for CholedocholithiasisStudies 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
- 3,000 participants (estimated)
- Target duration
- 30 Days
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Society of Digestive Endoscopy
- Responsible party
- Sponsor
- Investigators
- Edgar Castillo-Regalado, MD, Principal investigator, Hospital Universitario Germans Trias i Pujol (Badalona)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670547
- Sponsor's protocol ID
- PI-23-281
- Status last verified
- Oct 2024
- First submitted
- 22 Oct 2024
- Last updated
- 1 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data obtained through this study may be provided to qualified researchers with academic interest in ERCP and biliopancreatic diseases. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 10 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
Publications
Ministerio de Sanidad. Criterios homologados, acordados por el Consejo Interterritorial, que deben cumplir los CSUR para ser designados como de referencia del Sistema Nacional de Salud. Drenaje guiado por ecoendoscopia de la obstrucción biliopancreática compleja.
Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
PubMed 20189503Nass KJ, Zwager LW, van der Vlugt M, Dekker E, Bossuyt PMM, Ravindran S, Thomas-Gibson S, Fockens P. Novel classification for adverse events in GI endoscopy: the AGREE classification. Gastrointest Endosc. 2022 Jun;95(6):1078-1085.e8. doi: 10.1016/j.gie.2021.11.038. Epub 2021 Dec 8.
PubMed 34890695Brindise EM, Gerke H. Monitoring adverse events after ERCP: Call me maybe? Gastrointest Endosc. 2021 Apr;93(4):911-913. doi: 10.1016/j.gie.2020.08.036. No abstract available.
PubMed 33741091Theunissen F, van der Wiel SE, Ter Borg PCJ, Koch AD, Ouwendijk RJT, Slangen RME, Siersema PD, Bruno MJ; Trans.IT foundation study group. Implementation of mandatory ERCP registration in The Netherlands and compliance with European Society of Gastrointestinal Endoscopy performance measures: a multicenter database study. Endoscopy. 2022 Mar;54(3):262-267. doi: 10.1055/a-1499-7477. Epub 2021 Jun 9.
PubMed 34107538Lantinga MA, Theunissen F, Ter Borg PCJ, Bruno MJ, Ouwendijk RJT, Siersema PD; Trans.IT foundation study group. Impact of the COVID-19 pandemic on gastrointestinal endoscopy in the Netherlands: analysis of a prospective endoscopy database. Endoscopy. 2021 Feb;53(2):166-170. doi: 10.1055/a-1272-3788. Epub 2020 Oct 20.
PubMed 33080630Domagk 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 30340220Johnson G, Webster G, Boskoski I, Campos S, Golder SK, Schlag C, Anderloni A, Arnelo U, Badaoui A, Bekkali N, Christodoulou D, Czako L, Fernandez Y Viesca M, Hritz I, Hucl T, Kalaitzakis E, Kylanpaa L, Nedoluzhko I, Petrone MC, Poley JW, Seicean A, Vila J, Arvanitakis M, Dinis-Ribeiro M, Ponchon T, Bisschops R. Curriculum for ERCP and endoscopic ultrasound training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2021 Oct;53(10):1071-1087. doi: 10.1055/a-1537-8999. Epub 2021 Jul 26.
PubMed 34311472Kochar B, Akshintala VS, Afghani E, Elmunzer BJ, Kim KJ, Lennon AM, Khashab MA, Kalloo AN, Singh VK. Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc. 2015 Jan;81(1):143-149.e9. doi: 10.1016/j.gie.2014.06.045. Epub 2014 Aug 1.
PubMed 25088919
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective and Multicenter Spanish Registry of Quality Indicators and Adverse Events of Endoscopic Retrograde Cholangiopancreatography
- ClinicalTrials.gov ID
- NCT06670547
- Acronym / sponsor ID
- PI-23-281
- Conditions
- Choledocholithiasis, Choledocholithiasis With Acute Cholangitis, Cholangiocarcinoma, Sclerosing Cholangitis, Pancreatic Cancer Resectable, Pancreatic Cancer Non-resectable
- Keywords
- ERCP ADVERSE EVENTS, PERFORMANCE MEASURES
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Collaborators
- Spanish Society of Digestive Endoscopy
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 30 Oct 2028 (estimated)
- First posted
- 1 Nov 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.
Endoscopic retrograde cholangiopancreatography (ERCP) is a technique which combines endoscopic and radiological vision and allows for therapeutic procedures on pathologies of the pancreas and bile duct.
ERCP is a generally well tolerated procedure, nonetheless it is a complex technique that has a higher frequency of complications compared to most endoscopic procedures that can even be life-threatening. These complications are related to patient characteristics, experience of the endoscopist performing the procedure, and specific factors to the technique. Due to its complexity, quality assurance, operator training and auditing are required to increase success and minimize complications.
There are quality indicators suggested by the main scientific societies in relation to technical aspects and complications, recommending their monitoring and auditing. Most endoscopy units lack records to monitor quality and complications, which prevents the assessment of quality and the identification of areas for improvement.
Given the lack of evidence of the quality of ERCP in the Spanish population, the investigators will be conducting a multicenter, national prospective study that will include subjects who undergo ERCP.
Patient data and technical aspects of the procedure will be recorded and all included patients will be monitored to identify complications. The quality indicators obtained within the registry will be compared with those established by scientific societies and the relationship between complications and technical factors will be analyzed.
Detailed description
Currently, endoscopic retrograde cholangiopancreatography (ERCP) is a well-established procedure that is in continuous development, with an incidence and severity of adverse events (AEs) that differ substantially from those related to other endoscopic procedures, reaching up to 14.7% and with a mortality rate of 0.7%, even in expert centers 1. For this reason, it is essential to ensure the quality of ERCP procedures, requiring optimal training, capacity building and auditing to increase the success of the procedure and minimize the risk of complications 2.
In recent years, the evaluation of the quality of ERCP has gained interest among health professionals and patient organizations. In 2018, the European Society of Gastrointestinal Endoscopy (ESGE) and the United European Gastroenterology (UEG) published key quality recommendations for ERCP and endoscopic ultrasonography with the aim of encouraging healthcare professionals to implement these performance targets at national level 3. For ERCP there are 5 recommendations including adequate antibiotic prophylaxis before ERCP (at least 90%), biliary cannulation rate (at least 90%), adequate stent placement in patients with sub-hilum obstruction (at least 95%), removal of bile duct stones (at least 90%) and post-ERCP pancreatitis (less than 10%).
Following this line, endoscopists in the Netherlands have been using a mandatory nationwide quality register since 2016 (Trans.IT database; Rotterdam, the Netherlands), which provides information on the quality of ERCP 4. They have recently published the analysis of this register in relation to the ESGE quality recommendations. 5671 procedures performed by 57 endoscopists in 11 centres were included. Three key quality indicators were met: successful biliary cannulation, adequate placement of stents for biliary obstruction and removal of bile duct stones with a high overall success rate. These robust data from routine clinical practice also allow us to identify areas for improving the quality of ERCP, for example, successful cannulation of native papillae below 90% for endoscopists performing fewer than 50 procedures per year or the rate of adequate placement of biliary stents below 90% in endoscopists performing fewer than 25 procedures per year 5. Unfortunately, the rate of pancreatitis, which is the most appropriate indicator of the rate of adverse events, was not evaluated in this registry.
In our view, the collection of data at a national level is of undoubted value to identify areas for improvement and to guarantee quality in ERCP, however, there are no state databases in our setting.
The present study aims to evaluate the quality indicators of ERCP recommended by the ESGE-UEG in a Spanish prospective registry and to describe the real incidence of adverse events in clinical practice, and their association with technical aspects of the procedure.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 30 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with biliopancreatic pathology undergoing ERCP | – | Procedure: Endoscopic retrograde cholangiopancreatography (ERCP)Patients with biliopancreatic pathology who undergo ERCP are over 18 years of age and sign the informed consent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with biliopancreatic pathology for whom ERCP is performed in hospitals in Spain.
Key inclusion criteria (4 listed)
- All consecutive patients who have undergone an ERCP at participating centres from 1 November 2024 will be included. An ERCP will be considered to have been performed when an endoscope is introduced to access the duodenal papilla.
- Over 18 years of age
- Signed informed consent.
Key exclusion criteria (3 listed)
- Under 18 years of age
- Unavailability of informed consent
- Impossibility of follow-up.
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 |
|---|---|---|
| Endoscopic retrograde cholangiopancreatography (ERCP)Endoscopic retrograde cholangiopancreatography (ERCP) | Procedure or surgery | Patients with biliopancreatic pathology undergoing ERCP |
Primary outcome
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry
Time frame: Patients receiving antibiotic prophylaxis of at least one dose of any systemic antibiotic in a 12-hour interval prior to ERCP.
Number of participants receiving adequate antibiotic prophylaxis before ERCP.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
Time frame: Patients in whom biliary cannulation is achieved up to 1 hour after completion of ERCP.
Number of participants who achieved biliary cannulation.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
Time frame: Patients who successfully placed stents in obstructions distal to the hilum up to 1 hour after completion of ERCP.
Number of participants in whom stents are successfully placed in obstructions distal to the hilum.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
Time frame: Patients who successfully removed bile duct stones up to 1 hour after completion of ERCP.
Number of participants with successful removal of biliary tract stones.
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry.
Time frame: Patients who developed acute pancreatitis at 7 and 30 days after ERCP.
Number of participants developing post-ERCP pancreatitis.
1 secondary outcome
To describe the severity of adverse events in ERCP according to the AGREE classification and their association with technical aspects of the procedure
Time frame: Assessment of the development of adverse events at 24 hours according to the practice of each hospital; at 7 days and at 30 days after performing the ERCP by telephone call.
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 1 Nov 2024.
- BackgroundMinisterio de Sanidad. Criterios homologados, acordados por el Consejo Interterritorial, que deben cumplir los CSUR para ser designados como de referencia del Sistema Nacional de Salud. Drenaje guiado por ecoendoscopia de la obstrucción biliopancreática compleja.
- Background: PubMed 20189503Cotton PB, Eisen GM, Aabakken L, Baron TH, Hutter MM, Jacobson BC, Mergener K, Nemcek A Jr, Petersen BT, Petrini JL, Pike IM, Rabeneck L, Romagnuolo J, Vargo JJ. A lexicon for endoscopic adverse events: report of an ASGE workshop. Gastrointest Endosc. 2010 Mar;71(3):446-54. doi: 10.1016/j.gie.2009.10.027. No abstract available.
- Background: PubMed 34890695Nass KJ, Zwager LW, van der Vlugt M, Dekker E, Bossuyt PMM, Ravindran S, Thomas-Gibson S, Fockens P. Novel classification for adverse events in GI endoscopy: the AGREE classification. Gastrointest Endosc. 2022 Jun;95(6):1078-1085.e8. doi: 10.1016/j.gie.2021.11.038. Epub 2021 Dec 8.
- Background: PubMed 33741091Brindise EM, Gerke H. Monitoring adverse events after ERCP: Call me maybe? Gastrointest Endosc. 2021 Apr;93(4):911-913. doi: 10.1016/j.gie.2020.08.036. No abstract available.
- Background: PubMed 34107538Theunissen F, van der Wiel SE, Ter Borg PCJ, Koch AD, Ouwendijk RJT, Slangen RME, Siersema PD, Bruno MJ; Trans.IT foundation study group. Implementation of mandatory ERCP registration in The Netherlands and compliance with European Society of Gastrointestinal Endoscopy performance measures: a multicenter database study. Endoscopy. 2022 Mar;54(3):262-267. doi: 10.1055/a-1499-7477. Epub 2021 Jun 9.
- Background: PubMed 33080630Lantinga MA, Theunissen F, Ter Borg PCJ, Bruno MJ, Ouwendijk RJT, Siersema PD; Trans.IT foundation study group. Impact of the COVID-19 pandemic on gastrointestinal endoscopy in the Netherlands: analysis of a prospective endoscopy database. Endoscopy. 2021 Feb;53(2):166-170. doi: 10.1055/a-1272-3788. Epub 2020 Oct 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.
- Background: PubMed 34311472Johnson G, Webster G, Boskoski I, Campos S, Golder SK, Schlag C, Anderloni A, Arnelo U, Badaoui A, Bekkali N, Christodoulou D, Czako L, Fernandez Y Viesca M, Hritz I, Hucl T, Kalaitzakis E, Kylanpaa L, Nedoluzhko I, Petrone MC, Poley JW, Seicean A, Vila J, Arvanitakis M, Dinis-Ribeiro M, Ponchon T, Bisschops R. Curriculum for ERCP and endoscopic ultrasound training in Europe: European Society of Gastrointestinal Endoscopy (ESGE) Position Statement. Endoscopy. 2021 Oct;53(10):1071-1087. doi: 10.1055/a-1537-8999. Epub 2021 Jul 26.
- Background: PubMed 25088919Kochar B, Akshintala VS, Afghani E, Elmunzer BJ, Kim KJ, Lennon AM, Khashab MA, Kalloo AN, Singh VK. Incidence, severity, and mortality of post-ERCP pancreatitis: a systematic review by using randomized, controlled trials. Gastrointest Endosc. 2015 Jan;81(1):143-149.e9. doi: 10.1016/j.gie.2014.06.045. Epub 2014 Aug 1.
- Individual participant dataSharing planned: Yes. Data obtained through this study may be provided to qualified researchers with academic interest in ERCP and biliopancreatic diseases. Data or samples shared will be coded, with no PHI included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party. Data requests can be submitted starting 10 months after article publication and the data will be made accessible for up to 24 months. Extensions will be considered on a case-by-case basis.
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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.
Edgar Castillo-Regalado, MD principal investigator
Hospital Universitario Germans Trias i Pujol (Badalona)
Questions about this trial
What is this clinical trial studying?
An observational study of Choledocholithiasis and Choledocholithiasis With Acute Cholangitis, run by Germans Trias i Pujol Hospital.
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 4 inclusion and 3 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: opening soon, as of the sponsor's last update on 1 Nov 2024. 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?
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?
Contact Edgar Castillo-Regalado, MD (+34692338064, eecastillor.germanstrias@gencat.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate compliance with ESGE-UEG ERCP quality indicators in the Spanish registry (time frame: Patients receiving antibiotic prophylaxis of at least one dose of any systemic antibiotic in a 12-hour interval prior to ERCP.). The study lists 5 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 NCT06670547, which also lists 9 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 1 Nov 2024.