Choledochoscopy Multicenter Registry (SPY)

Choledochoscopy For Diagnosing Pancreatico-Biliary Disorders: A Multicenter Registry

The purpose of this registry is to record information and evaluate the impact of SpyGlassTM Direct Visualization System for choledochoscopy on the management of pancreatico-biliary disorders. The registry will evaluate diagnostic performance and overall clinical management impacted by SpyGlass.

This multi-center registry has been initiated:

• To document the impact of SpyGlass Choledochoscopy in pancreatico-biliary disorders on the clinical management of pancreatico-biliary disorders including malignancies.
• To assess the sensitivity, specificity, accuracy, technical feasibility, safety and cost effectiveness of SpyGlass and compare it to other diagnostic modalities.

Study Overview

• Status: Unknown
• Conditions: Pancreatico-biliary Disorder
• Intervention / Treatment: Procedure: Choledochoscopy using Digital Spyglass

Detailed Description

Our institution performs therapeutic Interventional Endoscopy in around 750-1000 patients a year. During these interventional procedures, advanced and emerging imaging techniques including choledochoscopy, choledochopancreatoscopy, confocal endomicroscopy, chromoendoscopy, narrow band imaging, etc. are conducted for presumptive or definitive diagnoses in some of the patients suffering pancreatico-biliary disorders; including malignancies. Early and accurate diagnosis is necessary to improve the prognosis for pancreatic cancer or cholangiocarcinoma. Initial studies have shown that advanced imaging including confocal microendoscopy may majorly impact the clinical management of patients by providing accurate diagnosis early on. Choledochoscopy is used for microendoscopic visualisation of lumen and mucous membrane, for diagnosis, classification and therapy of abnormally functioning gall-bladder and pancreatic systems. New refinements have allowed for single user direct imaging with endobiliary biopsy. SpyGlassTM Direct Visualization System (Boston Scientific, Natick, MA) is a platform designed to enhance diagnostic accuracy during ERCP (Endoscopic Retrograde Cholangiopancreatography) and allowing guided biopsy. It is an FDA approved instrument with the ability of performing cholangiopancreatoscopy by a single endoscopist during ERCP. A 1.2 mm working channel exists within the Spyglass system allowing for instrument access to the biliary or pancreatic tree. Advanced Endoscopists at various centers in the U.S, and outside U.S., use Choledochoscopy with SpyGlass to assist in the confirmation of diagnosis in patients having Billiary lesions. However, there is little data and thus neglibible evidence regarding the agreement of SPY interpretation within doctors. However, advanced endoscopists have only recently started to employ the SpyGlassTM Direct Visualization System for single operator choledochoscopy. Hence we lack enough data to accurately evaluate the sensitivity, specificity, accuracy, technical feasibility, safety and cost effectiveness of such imaging devices. Evaluation of these factors would help us compare them to conventional diagnostic options; and consequently help us identify appropriate imaging techniques for biliary and pancreatic disorders and improve clinical management of patients.

The purpose of this registry is to record information and evaluate the impact of SpyGlassTM Direct Visualization System for choledochoscopy on the management of pancreatico-biliary disorders. The registry will evaluate diagnostic performance and overall clinical management impacted by SpyGlass.

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medical College

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Any patient who has undergone SpyGlass Choledochoscopy procedures for diagnosis and/or treatment of a pancreatico-biliary disorder

Description

Inclusion Criteria:

• Any patient who has undergone SpyGlass Choledochoscopy procedures for diagnosis and/or treatment of a pancreatico-biliary disorder
• Above 18 years of age

Exclusion Criteria:

• Any patient who has not undergone choledochoscopy for pancreatico-biliary disorders
• Below 18 years of age

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SpyGlass Choledochoscopy procedure; Any patient who has undergone SpyGlass Choledochoscopy procedures for diagnosis and/or treatment of a pancreatico-biliary disorder	Procedure: Choledochoscopy using Digital Spyglass; Choledochoscopy using Digital Spyglass during Endoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Management	Documentation of accuracy, sensitivity, specificity, positive predictive value, negative predictive value based on final diagnosis variable (followup at a year for confirmed diagnosis if tissue results are negative or indeterminate).	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Profile	Documentation of Safety: Number of Participants with Adverse Events; Type, frequency and intensity of adverse events.	30 days post procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy profile	Documentation of technical success and clinical success rates. Technical success is defined as successful choledochoscopy done or not based on access and visual recording. Clinical success is defined as determination of diagnosis based on choledochoscopy imaging.	1 year

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University

Publications and helpful links

General Publications

• Kahaleh M, Gaidhane M, Shahid HM, Tyberg A, Sarkar A, Ardengh JC, Kedia P, Andalib I, Gress F, Sethi A, Gan SI, Suresh S, Makar M, Bareket R, Slivka A, Widmer JL, Jamidar PA, Alkhiari R, Oleas R, Kim D, Robles-Medranda CA, Raijman I. Digital single-operator cholangioscopy interobserver study using a new classification: the Mendoza Classification (with video). Gastrointest Endosc. 2022 Feb;95(2):319-326. doi: 10.1016/j.gie.2021.08.015. Epub 2021 Aug 31.
• Kahaleh M, Raijman I, Gaidhane M, Tyberg A, Sethi A, Slivka A, Adler DG, Sejpal D, Shahid H, Sarkar A, Martins F, Boumitri C, Burton S, Bertani H, Tarnasky P, Gress F, Gan I, Ardengh JC, Kedia P, Arnelo U, Jamidar P, Shah RJ, Robles-Medranda C. Digital Cholangioscopic Interpretation: When North Meets the South. Dig Dis Sci. 2022 Apr;67(4):1345-1351. doi: 10.1007/s10620-021-06961-z. Epub 2021 Mar 30.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): December 30, 2018

Study Registration Dates

• First Submitted: June 10, 2014
• First Submitted That Met QC Criteria: June 13, 2014
• First Posted (Estimate): June 18, 2014

Study Record Updates

• Last Update Posted (Actual): February 20, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 1206012450

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No IPD sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No