An observational study in Difficult Biliary Cannulation, sponsored by University of La Laguna. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-02-05.
Sponsored by University of La Laguna · Observational
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.
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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.
University of La Laguna is the lead sponsor of 16 studies on the registry; 7 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All consecutive patients who meet the inclusion criteria and none of the exclusion criteria will be offered participation in the study.
Exclusion Criteria:
Consecutive patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) will be included
Procedure: 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
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
Time frame: 1 year
A validation of the CNN
A validation of the CNN assessing the agreement between ESGE criteria and the CNN prediction
Time frame: 1 year
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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University of La Laguna