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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02232451

Acronym

loop

Enrollment

320

Registered

2014-09-05

Start date

2010-11-30

Completion date

2014-08-31

Last updated

2014-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Complications of Surgical and Medical Care: General Terms

Keywords

loop, ERCP, cannulation, biliary, wire

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.

Interventions

DEVICEERCP with loop tip wire

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

DEVICEERCP for cannulation

Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
The evaluation of the incidence of PEP	loop20216

Secondary

Measure	Time frame
The evaluation of CBD percentage cannulation.	loop20216

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026