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OpenTrials
Completed

NCT Number: NCT06380543

ERCP Biliary Cannulation Success Using ESGE Algorithm

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS OSpedale San Raffaele

Milan, Italy, 20132

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

Primary outcomes

  1. Success of ERCP biliary cannulation rate

    Time frame: At the end of the procedure.

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

Secondary outcomes

  1. ERCP complication rates

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

    pancreatitis, bleeding, perforation, or cholangitis according with the ESGE algorithm

Sponsors and collaborators

Lead sponsor

IRCCS San Raffaele

Other

Collaborators

  • Societa Italiana di Endoscopia Digestiva

Registry information

Official study title

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

Acronym: BILINCE

Important dates

Study start
2019
Primary completion
2024
Study completion
2025
First posted
Apr 24, 2024
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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