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Efficacy of Fistulotomy for Biliary Cannulation

RECRUITINGN/ASponsored by Coordinación de Investigación en Salud, Mexico
Actively Recruiting
PhaseN/A
SponsorCoordinación de Investigación en Salud, Mexico
Started2019-07-03
Est. completion2026-12-01
Eligibility
Age18 Years – 90 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT04037007

Summary

Access to the main bile duct is the first step in order to perform a therapeutic maneuver for biliary diseases. Early precut has been shown to ameliorate cannulation success rate, specially in difficult cannulation cases, when compared to guidewire cannulation (which is considered, for most, the standard technique). We aim to perform a randomized clinical trial comparing fistulotomy (F) precut vs guidewire cannulation (CC), as a primary cannulation technique, and compare outcomes between high experienced endoscopists (\> 200 ERCPs\[Endoscopic Retrograde cholangiopancreatography\]) and low experienced endoscopists (\< 200 ERCPs).

Eligibility

Age: 18 Years – 90 YearsHealthy volunteers accepted
Inclusion Criteria:

* All patients undergoing ERCP with suspected or confirmed of choledocholithiasis, malignant and benign biliary stenosis.

Exclusion Criteria:

* patients with previous ERCP, altered gastro-duodenal anatomy by previous surgery, suspicion or diagnosis of ampullary neoplasm, duodenal cancer, periampullary diverticula types 1 and 2, pregnant women, coagulopathy with INR greater than 1.5.

Elimination Criteria:

\- Incomplete procedure due to anesthesia adverse events.

Conditions5

CancerCholangiocarcinomaCholedocholithiasis; CholangitisPancreatic CancerPancreatitis

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