ERCP Biliary Cannulation Success Using ESGE Algorithm

Biliary Tract Diseases Clinical Trial

— BILINCE  

Official title:

Efficacy of ERCP Using ESGE Algorithm for Biliary Cannulation: a Multicenter Prospective Italian Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06380543
• Other study ID #: BILINCE
• Status: Recruiting
• Start date: December 12, 2019
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: IRCCS San Raffaele
• Contact: Alberto Mariani, MD
• Phone: 02/26436301
• Email: mariani.alberto[@]hsr.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: December 31, 2024
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• patients > 18 years of age;

• native papilla;

• signed Informed Consent;

Exclusion criteria:

• previous biliary sphincterotomy;

• post-surgical ERCP;

• ampulloma or papilla involved by a tumor;

• pancreatic endotherapy;

• patients unable to give consent for the procedure;

Related Conditions & MeSH terms

• Biliary Tract Diseases

Locations

Country	Name	City	State
Italy	IRCCS OSpedale San Raffaele	Milano

Sponsors (2)

Lead Sponsor	Collaborator
IRCCS San Raffaele	Societa Italiana di Endoscopia Digestiva

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ERCP complication rates	pancreatitis, bleeding, perforation, or cholangitis according with the ESGE algorithm	At 0-72 hours, and at 30-days after the procedure.