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

NCT ID: NCT02232451

Last Updated: 2014-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 320 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-30
• Study Completion Date: 2014-08-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ERCP with loop tip wire

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.

Group Type: EXPERIMENTAL

ERCP with loop tip wire

Intervention Type: DEVICE

Endoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation

ERCP for cannulation

ERCP for cannulation of CBD with traditional technique

Group Type: ACTIVE_COMPARATOR

ERCP for cannulation

Intervention Type: DEVICE

Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation

Interventions

ERCP with loop tip wire

Endoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation

Intervention Type: DEVICE

ERCP for cannulation

Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera San Paolo

OTHER

Sponsor Role: lead

Responsible Party

Enzo Masci

Chief of Gastrointestinal Endoscopy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Enzo Masci, MD

Role: STUDY_DIRECTOR

Hospital San Paolo

Other Identifiers

loop20216

Identifier Type: -

Identifier Source: org_study_id