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Italian Registry of ERCP With Spyglass

Italian Registry of ERCP With Spyglass

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04009746
Acronym
Spyglass
Enrollment
150
Registered
2019-07-05
Start date
2016-01-21
Completion date
2023-12-31
Last updated
2023-03-21

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

Conditions

Biliary Condition

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.

Interventions

PROCEDUREEndoscopic retrograde cholangiopancreatography (ERCP) with Spyglass

Endoscopic retrograde cholangiopancreatography (ERCP) with Spyglass

Sponsors

Istituto Clinico Humanitas
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Data collection of characteristics of ERCP with Spyglass12 MonthsFrequencies of complications and distribution of population undergoing ERCP

Countries

Italy

Contacts

Primary ContactAndrea Anderloni, MD
andrea.anderloni@humanitas..it0039-02-82247308

Outcome results

None listed

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