A Convolutional Neural Network for Difficult Biliary Cannulation

NCT07389915 | Not Yet Recruiting

• 1 other identifier: CNN difficult cannulation
• Study Type: observational
• Target: 600
• Locations: 0 countries
• Sites: N/A

Brief 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). 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. .

Conditions

Difficult Biliary Cannulation

Keywords

ERCP; Difficult biliary cannulation; Convolutional neural network; CNN

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (1)

• A validation of the CNN

  1 year

Study Arms (1)

Patients undergoing ERCP

Consecutive patients undergoing endoscopic retrograde cholangiopancreatography (ERCP) will be included

Procedure: Endoscopic retrograde cholangiopancreatography (ERCP)

Interventions

Endoscopic retrograde cholangiopancreatography (ERCP) PROCEDURE

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

Patients undergoing ERCP

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients who meet the inclusion criteria and none of the exclusion criteria will be offered participation in the study.

You may qualify if:

• Age \>18 years
• Signed informed consent
• Patients indicated for ERCP

You may not qualify if:

• 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

Sponsors & Collaborators

• University of La Laguna: lead

MeSH Terms

Interventions

Cholangiopancreatography, Endoscopic Retrograde

Intervention Hierarchy (Ancestors)

Cholangiography; Radiography, Abdominal; Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Endoscopy, Digestive System; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures

Central Study Contacts

Antonio Z Gimeno García, MD, PhD

CONTACT

34-922678039; antozeben@gmail.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start: February 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 5, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share