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Prospective Comparison Between Ultra Early NKF Versus Standard Cannulation Alone

Portugal334 participantsStarted 2020-06-01

Plain-language summary

Compare the ultra early fistulotomy strategy with standard cannulation methods for accessing the bile duct during endoscopic retrograde cholangiopancreatography (ERCP)

Who can participate

Age range18 Years

SexALL

See this in plain English?

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

From June 1, 2020 to June 1, 2022, all individuals referred for ERCP in the Digestive Endoscopy Unit of Santa Luzia Hospital (Unidade Local de Saúde do Alto Minho) will be invited to participate in the study. Inclusion Criteria: * ERCP with indication for biliary access * Naïve papilla Exclusion Criteria: * Flat papillas * Intradiverticular / Diverticular border papillas * Patients unable to sign or understand the informed consent * Patients with surgically altered anatomy * Patients with tumors of the papilla * Previous sphincterotomy * Spontaneous papillary fistula * Papilla not visualized

What they're measuring

Adverse events

Timeframe: 30 days from the procedure

Technical success

Timeframe: 1 day (same day of the procedure)

Trial details

NCT IDNCT04492137

SponsorUniversity of Minho

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-06-30

Contact for this trial

Luís Lopes, MD, PhD, MBA

00351932841974 luis.m.lopes@me.com

View on ClinicalTrials.gov More Pancreatitis trials