Cholangioscopy With Spyglass DS Using Percutaneous Transhepatic Cholangiography Access (Spy PTC)

Cholangioscopy With Spyglass DS Using Percutaneous Transhepatic Cholangiography Access: a Retrospective Cohort Study

Conventional peroral methods to visualize biliary strictures are not feasible in some patients with altered anatomy or biliary obstruction, and percutaneous transhepatic cholangioscopy can be used as an alternative procedure. This study aimed to retrospectively review the use of percutaneous transhepatic cholangiography using the SpyGlass DS technology (S-PTCS) during a 5-year period at a Danish tertiary referral center.

Study Overview

• Status: Completed
• Conditions: Biliary Stricture
• Intervention / Treatment: Procedure: Spy PTC

Detailed Description

Biliary strictures are caused by various disorders ranging from inflammatory strictures induced by primary sclerosing cholangitis (PSC) to strictures caused by cholangiocarcinoma. Identifying the etiology of these strictures is often difficult, but important, as treatment is dependent on the underlying cause1-3. To properly treat and diagnose biliary strictures, visualization of the target area is needed, and biopsies must be taken3,4. Conventional methods have poor accuracy in distinguishing between benign and malignant etiologies, and diagnosing these patients presents a challenge1,4,5.

Endoscopic retrograde pancreatography (ERCP) is the standard procedure for the treatment of biliary strictures1 and can be further supplemented with magnetic resonance cholangiopancreatography to increase diagnostic accuracy. However, ERCP is limited by its low diagnostic sensitivity6. Furthermore, some difficult strictures require direct visualization of the lesions with targeted biopsies. In such cases, peroral cholangioscopy (POCS) provides an alternative when traditional ERCP is not feasible. POCS can directly visualize target lesions, obtain targeted biopsies, and is shown to be safe and useful when diagnosing indeterminate biliary strictures1. However, some patients have previously undergone upper gastrointestinal surgery, which can alter both duodenal and biliary anatomy. Moreover, strictures caused by PSC may be multifocal and/or positioned over the biliary confluence, which can make visualization difficult2. Conventional ERCP and POCS are not feasible in these patients, and another approach is required7,8.

Percutaneous transhepatic cholangioscopy (PTCS) is an alternative, attractive procedure owing to a shorter and more straightforward route to all parts of the biliary tree. Studies have shown that PTCS is safe, effective, and feasible for the visualization of indeterminate biliary strictures and in cases with altered biliary anatomy7,9-12. In addition, the studies demonstrated high diagnostic accuracy of PTCS and reported a satisfactory rate of technical success7,9-12.

Despite these preliminary studies, literature concerning the feasibility of PTCS using SpyGlass DS technology (S-PTCS) remains sparse. This study aimed to evaluate the use, specifically the visual and histological success, and the specificity, sensitivity, and complication rate of S-PTCS during a 5-year period at a Danish tertiary referral center for upper gastrointestinal and hepato-pancreato-biliary surgery and transplantation.

• Study Type: Observational
• Enrollment (Actual): 22

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

See above

Description

Inclusion Criteria:

• People above the 18 who underwent Spy PTC in this 5 year period

Exclusion Criteria:

• People under the age of 18

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Spy PTC; People who had Spy PTC performed	Procedure: Spy PTC; Percutaneous transhepatic cholangioscopy with SpyGlass DS system

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success in terms of finding diagnosis	Success rate of Spy PTC finding diagnosis later verified through histopathology/scans	baseline, 1 month after the procedure, follow up 4 or more years later

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety in terms of complications	Number of participants with complications after procedure requiring intervention in general anesthesia	during the procedure, up to one month after procedure

Collaborators and Investigators

• Sponsor: Rigshospitalet, Denmark
• Investigators: Study Director: Michael P Achiam, MD, Ph.D, Rigshospitalet, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2016
• Primary Completion (Actual): December 1, 2021
• Study Completion (Actual): July 1, 2022

Study Registration Dates

• First Submitted: October 5, 2023
• First Submitted That Met QC Criteria: October 17, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Actual): October 23, 2023
• Last Update Submitted That Met QC Criteria: October 17, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Constriction, Pathologic
• Other Study ID Numbers: R-21069569

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The plan is to publish the study in a international medical journal.
• IPD Sharing Time Frame: The information will be published in a medical journal sometime during the next two years.
• IPD Sharing Access Criteria: Will be entered when accepted in a journal.
• IPD Sharing Supporting Information Type: CSR

Drug and device information, study documents

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