TerminatedNot Applicable

Early Precut in Difficult Biliary Cannulation

Stopped: Interim analysis recommended terminating the study

Italy375 participantsStarted 2012-01

Plain-language 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.

Who can participate

Age range18 Years – 85 Years

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Incidence of PEP

Timeframe: 24 hours

Trial details

NCT IDNCT02596646

SponsorUniversità Vita-Salute San Raffaele

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More Common Bile Duct Diseases trials