ERCP Biliary Cannulation Success Using ESGE Algorithm

NCT06380543 | Completed

• 1 other identifier: BILINCE
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Biliary Tract Diseases

Keywords

ERCP; biliary cannulation; post-ERCP complications

Outcome Measures

Primary Outcomes (1)

• Success of ERCP biliary cannulation rate

  Success obtained with the different cannulation techniques according with the ESGE algorithm

  At the end of the procedure.

Secondary Outcomes (1)

• ERCP complication rates

  At 0-72 hours, and at 30-days after the procedure.

Eligibility Criteria

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

Study Population

Patients with either benign or primary/secondary malignant bile duct disease.

You may qualify if:

• patients \> 18 years of age;
• native papilla;
• signed Informed Consent;

You may not qualify if:

• previous biliary sphincterotomy;
• post-surgical ERCP;
• ampulloma or papilla involved by a tumor;
• pancreatic endotherapy;
• patients unable to give consent for the procedure;

Sponsors & Collaborators

• IRCCS San Raffaele: lead
• Societa Italiana di Endoscopia Digestiva: collaborator

Study Sites (1)

IRCCS OSpedale San Raffaele

Milan, Italy, 20132, Italy

Location

MeSH Terms

Conditions

Biliary Tract Diseases

Condition Hierarchy (Ancestors)

Digestive System Diseases

Study Officials

• Alberto Mariani, MD

  IRCCS Ospedale San Raffaele

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 24, 2024
• Study Start: December 12, 2019
• Primary Completion: December 31, 2024
• Study Completion: March 30, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Locations

IT (1)