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

Hospital San Paolo320 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

320

Conditions

Post-ERCP Pancreatitis

Interventions

Loop-tip wire (Cook Medical) for the cannulation of the CBDDEVICE

Cannulotome CT-25mm Cook MedicalDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

San Paolo Hospital

Milan, Italy, Italy

RECRUITING

Outcomes

Primary Outcomes

post ERCP pancreatitis rate

participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Time frame: up to 4 weeks

Secondary Outcomes

Number of attempts to obtain the cannulation of CBD and number of participants with adverse events as a measure of safety and tolerability

participants will be followed for the duration of hospital stay, an expected average of 2 weeks

Time frame: up to 4 weeks

Data from ClinicalTrials.gov

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