Early Precut in Difficult Biliary Cannulation

Early Precut Sphincterotomy During ERCP With Difficult Biliary Access (Italian: Esecuzione Del Pre-cut Precoce in Corso di ERCP Con Difficoltosa Incannulazione Della Via Biliare)

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02596646

Enrollment

375

Registered

2015-11-04

Start date

2012-01-31

Completion date

2013-12-31

Last updated

2015-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Common Bile Duct Diseases

Brief summary

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.

Detailed 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).

Interventions

PROCEDUREEarly Precut

Early precut was performed during ERCP with difficult biliary cannulation

PROCEDUREProlonged cannulation attempts

Prolonged cannulation attempts was performed during ERCP with difficult biliary cannulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Age

18 Years to 85 Years

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.

Design outcomes

Primary

Measure	Time frame
Incidence of PEP	24 hours

Secondary

Measure	Time frame	Description
Incidence of overall complications	24 hours	The incidence of pancreatitis, cholangitis, perforation, bleeding after ERCP was recored. These complications were defined according to the protocol.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026