Cholangioscopy With Spyglass DS Using Percutaneous Transhepatic Cholangiography Access

Biliary Stricture Clinical Trial

— Spy PTC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06096129
• Other study ID #: R-21069569
• Status: Completed
• Start date: January 2016
• Est. completion date: July 2022

Study information

• Verified date: October 2023
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 2022
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• People under the age of 18

Related Conditions & MeSH terms

• Biliary Stricture
• Constriction, Pathologic

Intervention

Procedure:
• Spy PTC
Percutaneous transhepatic cholangioscopy with SpyGlass DS system

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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