Italian Registry of ERCP With Spyglass (Spyglass)

March 20, 2023 updated by: Istituto Clinico Humanitas

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Milano
      • Rozzano, Milano, Italy, 20089
        • Recruiting
        • Endoscopy Unit, Humanitas Research Hospital
        • Sub-Investigator:
          • Milena Di Leo, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

All patients will be recruited at the UO of Gastroenterology and digestive endoscopy of the participating centers

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituto Clinico Humanitas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2016

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

July 2, 2019

First Submitted That Met QC Criteria

July 3, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

March 21, 2023

Last Update Submitted That Met QC Criteria

March 20, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Registro SpyGlass

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Biliary Condition

Clinical Trials on Endoscopic retrograde cholangiopancreatography (ERCP) with Spyglass

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bahrain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe