Difficult Biliary CannulationPRECABIDO2NCT07389915
A Convolutional Neural Network for Difficult Biliary Cannulation
An observational study of Difficult Biliary Cannulation, run by University of La Laguna.
Trial summary
The main purpose of the study is to train a convolutional neural network (CNN) to predict difficult biliary canulation (DBC) following the European Society of Gastrointestinal Endoscopy Society (ESGE). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Difficult Biliary Cannulation
- What is being tested?
- Endoscopic retrograde cholangiopancreatography (ERCP)
- Type of treatment
- Surgery or procedure
- How many people
- 600 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Mar 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All consecutive patients who meet the inclusion criteria and none of the exclusion criteria will be offered participation in the study.
Who may be able to join
- Age >18 years
- Signed informed consent
- Patients indicated for ERCP
Who cannot join
- INR > 1.5
- Platelets < 50,000/mm³
- Patients with a prior endoscopic sphincterotomy
- Papilla of Vater not accessible via duodenoscope (gastric or duodenal stenosis due to neoplasm) or gastric surgery (Billroth II, Roux-en-Y)
- Known pancreas divisum
- Indication due to pancreatic duct pathology
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: Design and Validation of a Convolutional Neural Network to Predict Difficult Biliary Canulation: a Multicenter Study.
The main purpose of the study is to train a convolutional neural network (CNN) to predict difficult biliary canulation (DBC) following the European Society of Gastrointestinal Endoscopy Society (ESGE). Consecutive patients undergoing an endoscopic retrograde cholangiopancreatography (ERCP) will be included in the study. Several pictures of the second portion of the duodenum including the ampulla will be taken, along with several pictures of the radiological image. Pictures prospectively collected from the study PRECABIDO (NCT06591364), a multicenter study whith the purpose of evaluating the prevalence of difficult biliary cannulation and predictive factors for difficult cannulation and cannulation failure using ESGE criteria were also used for the training of the CNN.
We will also assess:
Read more
A validation of the CNN assessing the agreement between ESGE criteria and the CNN prediction.
To design a novel application based on the use of a convolutional neural network (CNN) to detect difficult biliary cannulation.
.
Read the detailed description
All consecutive patients who meet the inclusion criteria and none of the exclusion criteria will be offered participation in the study. They will be informed by one of the investigators from each center and will sign an informed consent form. A data collection sheet will be completed to record demographic data, the indication for the procedure, and technical variables.
The procedures will be performed by endoscopists with at least 200 ERCPs and more than 5 years of experience. All patients, except in cases of allergy, will receive 1 suppository of indomethacin or diclofenac before the procedure. In cases of allergy, pre-procedure hydration with Ringer's lactate will be administered if there is no contraindication (consider the protocol proposed by the ESGE: 3 mL/kg/hour during ERCP, 20 mL/kg as a bolus after ERCP, and 3 mL/kg/hour for 8 hours post-ERCP). The use of a pancreatic stent should be considered when indicated.
After the procedure, patients will remain hospitalized for at least 24 hours in the hospital. The patient's medical record will be reviewed 7 days after the procedure to check for any adverse effects, and a follow-up phone call will be made to detect any adverse effects.
Initially, a pilot study will be conducted with 600 patients, assessing based on the results-that is, the percentage of patients with difficult cannulation. At the beginning of the examination, at least three endoscopic images and three radiological images of the second portion of the duodenum will be captured for each patient. In patients undergoing endoscopic ultrasound (EUS), three additional images of the second portion of the duodenum at the level of the pancreatic head and common bile duct (CBD) will be obtained.
These images will be labeled as "CBD yes" or "CBD no" according to ESGE criteria, which will serve as the gold standard. Once labeled, the images will be used to train a convolutional neural network (CNN) capable of predicting, just before attempting biliary cannulation, whether it will be a CBD or not.
The prediction of the trained CNN will be able to be combined with the predictive model of difficult biliary cannulation obtaned from the study PRECABIDO NCT06591364 in order to improve the prediction.
- Conditions
- Difficult Biliary Cannulation
- Being tested
- Endoscopic retrograde cholangiopancreatography (ERCP)
- Keywords
- ERCP, Difficult biliary cannulation, Convolutional neural network, CNN
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
Patients with a clinical indication of Endoscopic retrograde cholangiopancreatography (ERCP) will be included in the study for malignant or benign conditions as in routine clinical practice. Endoscopic and radiological images of the second portion of the duodenum will be captured for each patient. In patients undergoing endoscopic ultrasound (EUS), additional images of the second portion of the duodenum at the level of the pancreatic head and common bile duct (CBD) will be obtained
| Study group | Role | What they receive |
|---|---|---|
| Patients undergoing ERCP | Consecutive patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) will be included Receives: Procedure: Endoscopic retrograde cholangiopancreatography (ERCP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To train a convolutional neural network to predict difficult biliary canulation
To train a convolutional neural network to predict difficult biliary canulation following the European Society of Gastrointestinal Endoscopy Society (ESGE): Assessment of difficult biliary cannulation defined by ESGE criteria (> 5 minutes duration until cannulation, > 5 cannulation attempts, > 1 passage of the guidewire into the main pancreatic duct). Based on these criteria pictures will be labelled as difficult biliary cannulation or not
Measured: 1 year
Secondary outcomes (1)
A validation of the CNN
A validation of the CNN assessing the agreement between ESGE criteria and the CNN prediction
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2026
- Study start1 Feb 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Biliary CannulationStudies 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
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of La Laguna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manuel Hernandez-Guerra, MD, University of La Laguna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07389915
- Sponsor's protocol ID
- CNN difficult cannulation
- Acronym
- PRECABIDO2
- Status last verified
- Jan 2026
- First submitted
- 28 Jan 2026
- Last updated
- 5 Feb 2026
- Results posted
- No
- 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 5 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Design and Validation of a Convolutional Neural Network to Predict Difficult Biliary Canulation: a Multicenter Study.
- ClinicalTrials.gov ID
- NCT07389915
- Acronym / sponsor ID
- PRECABIDO2 / CNN difficult cannulation
- Conditions
- Difficult Biliary Cannulation
- Keywords
- ERCP, Difficult biliary cannulation, Convolutional neural network, CNN
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- University of La LagunaUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 5 Feb 2026 (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 main purpose of the study is to train a convolutional neural network (CNN) to predict difficult biliary canulation (DBC) following the European Society of Gastrointestinal Endoscopy Society (ESGE). Consecutive patients undergoing an endoscopic retrograde cholangiopancreatography (ERCP) will be included in the study. Several pictures of the second portion of the duodenum including the ampulla will be taken, along with several pictures of the radiological image. Pictures prospectively collected from the study PRECABIDO (NCT06591364), a multicenter study whith the purpose of evaluating the prevalence of difficult biliary cannulation and predictive factors for difficult cannulation and cannulation failure using ESGE criteria were also used for the training of the CNN.
We will also assess:
A validation of the CNN assessing the agreement between ESGE criteria and the CNN prediction.
To design a novel application based on the use of a convolutional neural network (CNN) to detect difficult biliary cannulation.
.
Detailed description
All consecutive patients who meet the inclusion criteria and none of the exclusion criteria will be offered participation in the study. They will be informed by one of the investigators from each center and will sign an informed consent form. A data collection sheet will be completed to record demographic data, the indication for the procedure, and technical variables.
The procedures will be performed by endoscopists with at least 200 ERCPs and more than 5 years of experience. All patients, except in cases of allergy, will receive 1 suppository of indomethacin or diclofenac before the procedure. In cases of allergy, pre-procedure hydration with Ringer's lactate will be administered if there is no contraindication (consider the protocol proposed by the ESGE: 3 mL/kg/hour during ERCP, 20 mL/kg as a bolus after ERCP, and 3 mL/kg/hour for 8 hours post-ERCP). The use of a pancreatic stent should be considered when indicated.
After the procedure, patients will remain hospitalized for at least 24 hours in the hospital. The patient's medical record will be reviewed 7 days after the procedure to check for any adverse effects, and a follow-up phone call will be made to detect any adverse effects.
Initially, a pilot study will be conducted with 600 patients, assessing based on the results-that is, the percentage of patients with difficult cannulation. At the beginning of the examination, at least three endoscopic images and three radiological images of the second portion of the duodenum will be captured for each patient. In patients undergoing endoscopic ultrasound (EUS), three additional images of the second portion of the duodenum at the level of the pancreatic head and common bile duct (CBD) will be obtained.
These images will be labeled as "CBD yes" or "CBD no" according to ESGE criteria, which will serve as the gold standard. Once labeled, the images will be used to train a convolutional neural network (CNN) capable of predicting, just before attempting biliary cannulation, whether it will be a CBD or not.
The prediction of the trained CNN will be able to be combined with the predictive model of difficult biliary cannulation obtaned from the study PRECABIDO NCT06591364 in order to improve the prediction.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients undergoing ERCP | – | Procedure: Endoscopic retrograde cholangiopancreatography (ERCP)Consecutive patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) will be included |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All consecutive patients who meet the inclusion criteria and none of the exclusion criteria will be offered participation in the study.
Key inclusion criteria (3 listed)
- Age >18 years
- Signed informed consent
- Patients indicated for ERCP
Key exclusion criteria (6 listed)
- INR > 1.5
- Platelets < 50,000/mm³
- Patients with a prior endoscopic sphincterotomy
- Papilla of Vater not accessible via duodenoscope (gastric or duodenal stenosis due to neoplasm) or gastric surgery (Billroth II, Roux-en-Y)
- Known pancreas divisum
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)Patients with a clinical indication of Endoscopic retrograde cholangiopancreatography (ERCP) will be included in the study for malignant or benign conditions as in routine clinical practice. Endoscopic and radiological images of the second portion of the duodenum will be captured for each patient. In patients undergoing endoscopic ultrasound (EUS), additional images of the second portion of the duodenum at the level of the pancreatic head and common bile duct (CBD) will be obtained | Procedure or surgery | Patients undergoing ERCP |
Primary outcome
To train a convolutional neural network to predict difficult biliary canulation
Time frame: 1 year
To train a convolutional neural network to predict difficult biliary canulation following the European Society of Gastrointestinal Endoscopy Society (ESGE): Assessment of difficult biliary cannulation defined by ESGE criteria (> 5 minutes duration until cannulation, > 5 cannulation attempts, > 1 passage of the guidewire into the main pancreatic duct). Based on these criteria pictures will be labelled as difficult biliary cannulation or not
1 secondary outcome
A validation of the CNN
Time frame: 1 year
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 5 Feb 2026.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
An observational study of Difficult Biliary Cannulation, run by University of La Laguna.
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 6 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 5 Feb 2026. 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 Antonio Z Gimeno García, MD, PhD (34-922678039 ext. 34039, antozeben@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To train a convolutional neural network to predict difficult biliary canulation (time frame: 1 year). 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 5 Feb 2026; AzTrials last refreshed its copy on 27 Oct 2026.