Comparison Of Loop-Tip Wire Vs Tradictional Technique In The Cannulation Of The Common Bile Duct

Not Applicable

• Conditions: Post-ERCP Pancreatitis
• Interventions: Device: Loop-tip wire (Cook Medical) for the cannulation of the CBD; Device: Cannulotome CT-25mm Cook Medical

• Registration Number: NCT01771419
• Lead Sponsor: Hospital San Paolo

Brief Summary

Selective cannulation of common bile duct (CBD) by insertion of a guide-wire seems to be associated with fewer complications and post-ERCP (Endoscopic retrograde cholangiopancreatography) pancreatitis (PEP) rate than the conventional biliary tree access with cannulotome (CT-25 Cook Medical) 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Status Verified: 2013-01
• Study First Submitted: 2013-01-15
• Study First Submitted QC: 2013-01-16
• Last Update Submitted: 2013-01-16
• Study First Posted: 2013-01-18
• Last Update Posted: 2013-01-18
• Primary Completion: 2013-02
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

Inclusion Criteria

• high-risk patients for post-ERCP pancreatitis

Exclusion Criteria

• age < 18 years
• allargy to the contrast medium
• previous biliary or gastric surgery
• neoplastic patients
• previous biliary or pancreatic sphincterotomy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
loop-tip arm	Loop-tip wire (Cook Medical) for the cannulation of the CBD	The cannulation of CBD will be obtained using the loop-tip wire (Cook Medical inc.)
Control arm	Cannulotome CT-25mm Cook Medical	The cannulation of CBD will be obtained with a Cook Medical sphincterotome CT-25 mm (tradictional technique)

Primary Outcome Measures

Name	Time	Method
post ERCP pancreatitis rate	up to 4 weeks	participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Secondary Outcome Measures

Name	Time	Method
Number of attempts to obtain the cannulation of CBD and number of participants with adverse events as a measure of safety and tolerability	up to 4 weeks	participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Trial Locations

Locations (1)

San Paolo Hospital; 🇮🇹 Milan, Italy