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

Azienda Ospedaliera San Paolo

Status: Completed

Conditions: Complications of Surgical and Medical Care: General Terms

Treatments: Device: ERCP with loop tip wire; Device: ERCP for cannulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02232451

loop20216

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• high risk patients for post-ERCP pancreatitis

Exclusion criteria

• age < 18 yrs
• allergy to the contrast medium
• previous surgery
• neoplastic bilio-pancreatic disease
• previous EBS

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

ERCP with loop tip wire

Experimental group

Description:

ERCP with loop tip wire is an endoscopic procedure to treat biliary disease. Wire guide cannulation with loop-tip is a new procedure to improve rate of biliary cannulation and reduce complication, as post-procedure pancreatitis.

Treatment:

Device: ERCP with loop tip wire

ERCP for cannulation

Active Comparator group

Description:

ERCP for cannulation of CBD with traditional technique

Treatment:

Device: ERCP for cannulation