Italian Registry of ERCP With Spyglass

NCT ID: NCT04009746

Last Updated: 2023-03-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 150 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-01-21
• Study Completion Date: 2023-12-31

Brief 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.

Conditions

Biliary Condition

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Endoscopic retrograde cholangiopancreatography (ERCP) with Spyglass

Endoscopic retrograde cholangiopancreatography (ERCP) with Spyglass

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Istituto Clinico Humanitas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Andrea Anderloni, MD

Role: CONTACT

andrea.anderloni@humanitas..it

0039-02-82247308

Facility Contacts

Alessandro Repici, MD

Role: primary

alessandro.repici@humanitas.it

+39282247493

Other Identifiers

Registro SpyGlass

Identifier Type: -

Identifier Source: org_study_id