Spy PTC: Cholangioscopy With Spyglass DS Using Percutaneous Transhepatic Cholangiography Access

Sponsor
Rigshospitalet, Denmark (Other)
Overall Status
Completed
CT.gov ID
NCT06096129
Collaborator
(none)
22
78

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
22 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Cholangioscopy With Spyglass DS Using Percutaneous Transhepatic Cholangiography Access: a Retrospective Cohort Study
Actual Study Start Date :
Jan 1, 2016
Actual Primary Completion Date :
Dec 1, 2021
Actual Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Spy PTC

People who had Spy PTC performed

Procedure: Spy PTC
Percutaneous transhepatic cholangioscopy with SpyGlass DS system

Outcome Measures

Primary Outcome Measures

  1. Success in terms of finding diagnosis [baseline, 1 month after the procedure, follow up 4 or more years later]

    Success rate of Spy PTC finding diagnosis later verified through histopathology/scans

Secondary Outcome Measures

  1. Safety in terms of complications [during the procedure, up to one month after procedure]

    Number of participants with complications after procedure requiring intervention in general anesthesia

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • People above the 18 who underwent Spy PTC in this 5 year period
Exclusion Criteria:
  • People under the age of 18

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Rigshospitalet, Denmark

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Trygve Ulvund Solstad, MD (Medical Doctor), Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT06096129
Other Study ID Numbers:
  • R-21069569
First Posted:
Oct 23, 2023
Last Update Posted:
Oct 23, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Oct 23, 2023