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

Complications of Surgical and Medical Care: General Terms Clinical Trial

— loop  

Official title:

Comparison of Loop-tip Cook Medical® Wire vs Traditional Endoscopic Technique Cannulation in the Prevention of Post-ercp Pancreatitis and Biliary Tree Access in High-risk Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02232451
• Other study ID #: loop20216
• Status: Completed
• Phase: N/A
• First received: August 1, 2012
• Last updated: September 23, 2014
• Start date: November 2010
• Est. completion date: August 2014

Study information

• Verified date: September 2014
• Source: Azienda Ospedaliera San Paolo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 320
• Est. completion date: August 2014
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Complications of Surgical and Medical Care: General Terms

Intervention

Device:
• ERCP with loop tip wire
Endoscopic retrograde cholangio-pancreatography with guide wire (loop-tip) for CBD cannulation
• ERCP for cannulation
Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera San Paolo

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The evaluation of the incidence of PEP		loop20216	Yes
Secondary	The evaluation of CBD percentage cannulation.		loop20216	Yes