Early Precut in Difficult Biliary Cannulation

Università Vita-Salute San Raffaele375 enrolled

Overview

This study evaluates whether an early precut strategy in cases of difficult biliary cannulation could reduce the incidence of PEP compared with that after prolonged cannulation attempts. Secondary aims are to compare the success of biliary cannulation and complications rates of the two techniques.

In this prospective multicenter randomized clinical trial the investigators assign patients referred for therapeutic biliary ERCP and difficult biliary cannulation (unsuccessful cannulation after 5 minutes) to early precut (group A) or repeated papillary cannulation attempts followed, in case of failure, by late precut (group B). Group A patients undergo precut immediately after randomization ("early precut"), while for group B cannulation attempts are continued for another 10 minutes, after which a precut is done if these fail or there are three unintended additional passages of the guide-wire into the MPD ("delayed precut").

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

375

Conditions

Common Bile Duct Diseases

Interventions

Early PrecutPROCEDURE

Early precut was performed during ERCP with difficult biliary cannulation

Prolonged cannulation attemptsPROCEDURE

Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation

Eligibility

Min age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 18 to 85 years of age who were scheduled to undergo therapeutic biliary ERCP. Exclusion Criteria: * active cholangitis or pancreatitis * chronic pancreatitis, * previous sphincterotomy, * prior gastric surgery, * coagulopathy, * severe comorbidity (need for tracheal intubation) * patients who refused or were unable to give informed consent. * patients with successful CBD cannulation within 5 minutes of standard attempts and fewer than three passages of the guidewire into the main pancreatic duct (MPD) (arbitrarily defined as "easy CBD cannulation"), * detection of ampulloma or peri-papillary diverticula during ERCP.

Locations (1)

San Raffaele Hospital

Milan, Italy

Outcomes

Primary Outcomes

Incidence of PEP

Time frame: 24 hours

Secondary Outcomes

Incidence of overall complications

The incidence of pancreatitis, cholangitis, perforation, bleeding after ERCP was recored. These complications were defined according to the protocol.

Time frame: 24 hours

Data from ClinicalTrials.gov

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