Efficacy of Fistulotomy for Biliary Cannulation

Recruiting now · Not applicable

Conditions studied: Cholangiocarcinoma, Choledocholithiasis; Cholangitis, Pancreatic Cancer, Pancreatitis

In brief

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).

Key facts

Study ID

NCT04037007

Run by

Coordinación de Investigación en Salud, Mexico

People needed

320

Starts

2019-07-03

Expected to finish

2026-12-01

Last updated by the study team

2025-05-01

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.

Where it is running

• Centro Medico Nacional Siglo XXI Hospital de Especialidades — Mexico City, Mexico City, Mexico (enrolling)

Full record on ClinicalTrials.gov

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