Biliary Tract DiseasesBILINCENCT06380543
ERCP Biliary Cannulation Success Using ESGE Algorithm
An observational study of Biliary Tract Diseases, run by IRCCS San Raffaele at 1 site in Italy.
Trial summary
Papillary cannulation attempts have been shown to be an independent predictor of post-ERCP pancreatitis (PEP) when they are repeated more than 5 times or for 5 minutes or when the pancreatic duct is opacified or cannulated by using guidewire more than 1 time. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Tract Diseases
- How many people
- 200 participants
- Where
- 1 siteItaly
- Study dates
- 12 Dec 2019to 30 Mar 2025
- 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 with either benign or primary/secondary malignant bile duct disease.
Who may be able to join
- patients > 18 years of age;
- native papilla;
- signed Informed Consent;
Who cannot join
- previous biliary sphincterotomy;
- post-surgical ERCP;
- ampulloma or papilla involved by a tumor;
- pancreatic endotherapy;
- patients unable to give consent for the procedure;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of ERCP Using ESGE Algorithm for Biliary Cannulation: a Multicenter Prospective Italian Study
Papillary cannulation attempts have been shown to be an independent predictor of post-ERCP pancreatitis (PEP) when they are repeated more than 5 times or for 5 minutes or when the pancreatic duct is opacified or cannulated by using guidewire more than 1 time. In order to reduce complications, the 2016 ESGE guideline recommends a precise sequence of alternative cannulation techniques to the primary guidewire approach before exceeding the stated limits. However, there are no published data about the routinary application of this biliary cannulation algorithm.
The investigators hypothesised that the ESGE algorithm predicts an increased cannulation success. Nevertheless, it's unclear if this benefit is also associated with a decreased risk of complications, mainly post-procedural pancreatitis.
Read the detailed description
Multicenter prospective observational study, which was promoted by SIED (the Italian Society of Digestive Endoscopy) involving Italian Centers that perform ERCP.
The study was approved from the Ethics Committee in 2020 with an expected enrollment of 800 patients over three years, with the potential to enroll patients for an extended period of time.
Each Center have to enroll a minimum of 15 consecutive patients, depending on the number of enrolling centers.
Each patient need to undergo ERCP by using the different cannulation techniques reported in the ESGE algorithm, which are numbered from 1 (easy cannulation) to 9 (difficult cannulation).
Digital data entry (RedCap application) are divided in three part: 1. before ERCP (patient demographics, indications for ERCP, the degree of anesthetic risk (ASA 1-3), any prophylactic therapy for pancreatitis, any assumption/interruption of anti-platelet and/or anti-coagulant drugs, the type of sedation); 2. ERCP (cannulation details according to ESGE algorithm, difficulty and duration of the procedure, final diagnosis, expertise of the endoscopist); 3. After ERCP (early and at 30-days complications, defined and graded according to the Cotton classification).
- Conditions
- Biliary Tract Diseases
- Keywords
- ERCP, biliary cannulation, post-ERCP complications
- Medical subject headings
- Biliary Tract Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Success of ERCP biliary cannulation rate
Success obtained with the different cannulation techniques according with the ESGE algorithm
Measured: At the end of the procedure.
Secondary outcomes (1)
ERCP complication rates
pancreatitis, bleeding, perforation, or cholangitis according with the ESGE algorithm
Measured: At 0-72 hours, and at 30-days after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2024
- Study start12 Dec 2019
- Primary completion31 Dec 2024
- Study completion30 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary Tract DiseasesStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- IRCCS San Raffaele
- Sponsor type
- University, hospital or other
- Collaborators
- Societa Italiana di Endoscopia Digestiva
- Responsible party
- Principal investigator, Alberto Mariani, IRCCS San Raffaele
- Investigators
- Alberto Mariani, MD, Principal investigator, IRCCS Ospedale San Raffaele
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380543
- Sponsor's protocol ID
- BILINCE
- Acronym
- BILINCE
- Status last verified
- May 2025
- First submitted
- 18 Apr 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of ERCP Using ESGE Algorithm for Biliary Cannulation: a Multicenter Prospective Italian Study
- ClinicalTrials.gov ID
- NCT06380543
- Acronym / sponsor ID
- BILINCE / BILINCE
- Conditions
- Biliary Tract Diseases
- Keywords
- ERCP, biliary cannulation, post-ERCP complications
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- IRCCS San RaffaeleUniversity, hospital or other
- Collaborators
- Societa Italiana di Endoscopia Digestiva
- Study start
- 12 Dec 2019 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 24 Apr 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.
Papillary cannulation attempts have been shown to be an independent predictor of post-ERCP pancreatitis (PEP) when they are repeated more than 5 times or for 5 minutes or when the pancreatic duct is opacified or cannulated by using guidewire more than 1 time. In order to reduce complications, the 2016 ESGE guideline recommends a precise sequence of alternative cannulation techniques to the primary guidewire approach before exceeding the stated limits. However, there are no published data about the routinary application of this biliary cannulation algorithm.
The investigators hypothesised that the ESGE algorithm predicts an increased cannulation success. Nevertheless, it's unclear if this benefit is also associated with a decreased risk of complications, mainly post-procedural pancreatitis.
Detailed description
Multicenter prospective observational study, which was promoted by SIED (the Italian Society of Digestive Endoscopy) involving Italian Centers that perform ERCP.
The study was approved from the Ethics Committee in 2020 with an expected enrollment of 800 patients over three years, with the potential to enroll patients for an extended period of time.
Each Center have to enroll a minimum of 15 consecutive patients, depending on the number of enrolling centers.
Each patient need to undergo ERCP by using the different cannulation techniques reported in the ESGE algorithm, which are numbered from 1 (easy cannulation) to 9 (difficult cannulation).
Digital data entry (RedCap application) are divided in three part: 1. before ERCP (patient demographics, indications for ERCP, the degree of anesthetic risk (ASA 1-3), any prophylactic therapy for pancreatitis, any assumption/interruption of anti-platelet and/or anti-coagulant drugs, the type of sedation); 2. ERCP (cannulation details according to ESGE algorithm, difficulty and duration of the procedure, final diagnosis, expertise of the endoscopist); 3. After ERCP (early and at 30-days complications, defined and graded according to the Cotton classification).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with either benign or primary/secondary malignant bile duct disease.
Key inclusion criteria (3 listed)
- patients > 18 years of age;
- native papilla;
- signed Informed Consent;
Key exclusion criteria (5 listed)
- previous biliary sphincterotomy;
- post-surgical ERCP;
- ampulloma or papilla involved by a tumor;
- pancreatic endotherapy;
- patients unable to give consent for the procedure;
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
Success of ERCP biliary cannulation rate
Time frame: At the end of the procedure.
Success obtained with the different cannulation techniques according with the ESGE algorithm
1 secondary outcome
ERCP complication rates
Time frame: At 0-72 hours, and at 30-days after the 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 13 May 2025.
- 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. This study is not recruiting at the moment.
Alberto Mariani, MD principal investigator
IRCCS Ospedale San Raffaele
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 Tract Diseases, run by IRCCS San Raffaele at 1 site in Italy.
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 3 inclusion and 5 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 13 May 2025. 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 Italy. 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?
Success of ERCP biliary cannulation rate (time frame: At the end of the procedure.). 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 13 May 2025.