Italian Registry of ERCP With Spyglass

Biliary Condition Clinical Trial

— Spyglass  

Official title:

Italian Registry of ERCP With Spyglass

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04009746
• Other study ID #: Registro SpyGlass
• Status: Recruiting
• Start date: January 21, 2016
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2023
• Source: Istituto Clinico Humanitas
• Contact: Andrea Anderloni, MD
• Phone: 0039-02-82247308
• Email: andrea.anderloni[@]humanitas..it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Biliary Condition

Intervention

Procedure:
• Endoscopic retrograde cholangiopancreatography (ERCP) with Spyglass
Endoscopic retrograde cholangiopancreatography (ERCP) with Spyglass

Locations

Country	Name	City	State
Italy	Endoscopy Unit, Humanitas Research Hospital	Rozzano	Milano

Sponsors (1)

Lead Sponsor	Collaborator
Istituto Clinico Humanitas

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Data collection of characteristics of ERCP with Spyglass	Frequencies of complications and distribution of population undergoing ERCP	12 Months