Italian Registry of ERCP With Spyglass

Study Overview
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Brief Summary
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Endoscopic retrograde cholangiopancreatography (ERCP) is a procedure used for the diagnosis and treatment of diseases of the biliary tract, pancreas and papilla of Vater. The ERCP allows an indirect vision of the ductal and pancreatic system by means of the endoductal injection of contrast medium and the evaluation of these by X-rays. Recently, cholangioscopy has been developed using the Spy Glass system, introduced on the market in 2007. This allows a direct visualization of the bile duct and pancreatic pathway through the introduction of an optical probe inside the ductal system. SpyGlass was developed to overcome the limitations of traditional cholangioscopy and allow optically guided therapies for the treatment of stenoses and calculations. This is the first cholangioscopy system performed by a single disposable operator (SOC), with two dedicated irrigation channels, an optical channel and a therapeutic channel with a diameter of 1.2 mm. Everything is placed inside a 10 Fr Spy Scope ™ access and delivery catheter (3.3 mm), which allows the tip to flex in 4 directions to facilitate maneuverability and directionality in small ducts. The irrigation channels of the SOC system allow a fluid flow rate of four to five times higher than that which can be obtained through the operating channel of conventional systems. In bench simulations with loaded Spy Bite ™ biopsy forceps, the SOC system presented a success rate in obtaining access to sites of double interest compared to that of a conventional 2-way limited bending choledocoscope. Some studies have confirmed the adequacy of the Spy Glass system in providing adequate samples for histological diagnosis and successfully facilitating the treatment of stones. The new single-use Spy Glass digital display system was introduced in 2014 and no multi-center experience on the use of this device is described to date.

Official Title
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Italian Registry of ERCP With Spyglass

Conditions
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Biliary Condition

Intervention / Treatment
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* Procedure: Endoscopic retrograde cholangiopancreatography (ERCP) with Spyglass


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: With an age above or equal to 18, From which informed consent has been obtained, Subjected to ERCP carried out by expert operators, Subject to ERCP with SpyGlass. Patients who do not meet all of the listed inclusion criteria will be excluded from this study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Endoscopic retrograde cholangiopancreatography (ERCP) with Spyglass|Endoscopic retrograde cholangiopancreatography (ERCP) with Spyglass|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Data collection of characteristics of ERCP with Spyglass | Frequencies of complications and distribution of population undergoing ERCP | 12 Months |