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

Hospital San Paolo

Status: Unknown

Conditions: Post-ERCP Pancreatitis

Treatments: Device: Cannulotome CT-25mm Cook Medical; Device: Loop-tip wire (Cook Medical) for the cannulation of the CBD

Study type: Interventional

Funder types: Other

Identifiers

NCT01771419

H San Paolo

Details and patient eligibility

About

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.

Enrollment: 320 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

loop-tip arm

Experimental group

Description:

The cannulation of CBD will be obtained using the loop-tip wire (Cook Medical inc.)

Treatment:

Device: Loop-tip wire (Cook Medical) for the cannulation of the CBD

Control arm

Active Comparator group

Description:

The cannulation of CBD will be obtained with a Cook Medical sphincterotome CT-25 mm (tradictional technique)

Treatment:

Device: Cannulotome CT-25mm Cook Medical