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Completed

NCT Number: NCT02232451

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

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.

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Key information

Conditions

Complications of Surgical and Medical Care: General Terms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ERCP with loop tip wire

Device

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

ERCP for cannulation

Device

Endoscopic retrograde cholangio-pancreatography with traditional technique for CBD cannulation

Primary outcomes

  1. The evaluation of the incidence of PEP

    Time frame: loop20216

Secondary outcomes

  1. The evaluation of CBD percentage cannulation.

    Time frame: loop20216

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliera San Paolo

Other

Registry information

Official study 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

Acronym: loop

Important dates

Study start
2010
Primary completion
2012
Study completion
2014
First posted
Sep 5, 2014
Registry last updated
Sep 25, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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