Efficacy and Safety of Precut Fistulotomy vs Conventional Cannulation Technique as a Primary Approach to Biliary Access According to the Endoscopist Experience Degree in ERCP

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

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

Locations
Other Locations
Mexico
Centro Medico Nacional Siglo XXI Hospital de Especialidades
RECRUITING
Mexico City
Contact Information
Primary
Oscar V Hernández Mondragón, MD
mondragonmd@yahoo.co.uk
+525556276900
Backup
Carlos Mendoza Segura, Fellow
carlosms.gastro@gmail.com
+525556276900
Time Frame
Start Date: 2019-07-03
Estimated Completion Date: 2026-12-01
Participants
Target number of participants: 320
Treatments
Active_comparator: Fistulotomy - High experienced
Fistulotomy precut with a needle knife, ERBE Endocut I, Effect 2; as the primary cannulation technique in high experienced endoscopists.
Active_comparator: Fistulotomy - Low experienced
Fistulotomy precut with a needle knife, ERBE Endocut I, Effect 2; as the primary cannulation technique in low experienced endoscopists.
Active_comparator: Conventional (guidewire) cannulation- High experience
Conventional cannulation with an sphincterotome and 0.035 inch hydrophilic tip guidewire as the primary cannulation technique in high experienced endoscopists.
Active_comparator: Conventional (guidewire) cannulation - Low experienced.
Conventional cannulation with an sphincterotome and 0.035 inch hydrophilic tip guidewire as the primary cannulation technique in low experienced endoscopists.
Sponsors
Leads: Coordinación de Investigación en Salud, Mexico

This content was sourced from clinicaltrials.gov

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