NCT02232451

Comparison of Loop-tip Cook Medical® Wire Versus Traditional Endoscopic Technique

Comparison of Loop-tip Cook Medical® Wire vs Traditional Endoscopic Technique Cannulation in the Prevention of Post-ercp Pancreatitis and Biliary Tree Access in High-risk Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (actual)
• Sponsor: Azienda Ospedaliera San Paolo · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in post-ERCP pancreatitis in high-risk patients.

Detailed description

Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complication and post-ERCP pancreatitis (PEP) rate than the conventional biliary tree access with contrast injection even if results are conflicting. The aim of our study is to test a new guide-wire (loop-tip wire) with a loop in the tip for the prevention of PEP and biliary tree access, in PEP high-risk patients. Type of study: Multicentric, prospective and randomized trial Patients: PEP high-risk patients underwent ERCP for benign biliary pathology Number of patients: 320 patients (160 for each group) Aim: Primary end point: The evaluation of the incidence of PEP . Secondary end point: The evaluation of CBD percentage cannulation.

Conditions

• Complications of Surgical and Medical Care: General Terms

Interventions

Type	Name	Description
DEVICE	ERCP with loop tip wire	Endoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation
DEVICE	ERCP for cannulation	Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation

Timeline

• Start date: 2010-11-01
• Primary completion: 2012-06-01
• Completion: 2014-08-01
• First posted: 2014-09-05
• Last updated: 2014-09-25