Early Precut in Difficult Biliary Cannulation

Università Vita-Salute San Raffaele

Status

Terminated

Conditions

Common Bile Duct Diseases

Treatments

Procedure: Early Precut

Procedure: Prolonged cannulation attempts

Study type

Interventional

Funder types

Other

Identifiers

NCT02596646

PRECUT PRECOCE/01

Details and patient eligibility

About

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.

Full description

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").

Enrollment

375 patients

Sex

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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.