NCT06096129

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2022

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2023

Completed
18 days until next milestone

First Posted

Study publicly available on registry

October 23, 2023

Completed
Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

5.9 years

First QC Date

October 5, 2023

Last Update Submit

October 17, 2023

Conditions

Biliary Stricture

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Safety in terms of complications

    during the procedure, up to one month after procedure

Study Arms (1)

Spy PTC

People who had Spy PTC performed

Procedure: Spy PTC

Interventions

Spy PTCPROCEDURE

Percutaneous transhepatic cholangioscopy with SpyGlass DS system

Spy PTC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

See above

You may qualify if:

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

You may not qualify if:

  • People under the age of 18

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Michael P Achiam, MD, Ph.D

    Rigshospitalet, Denmark

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD (Medical Doctor)

Study Record Dates

First Submitted

October 5, 2023

First Posted

October 23, 2023

Study Start

January 1, 2016

Primary Completion

December 1, 2021

Study Completion

July 1, 2022

Last Updated

October 23, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will share

The plan is to publish the study in a international medical journal.

Shared Documents
CSR
Time Frame
The information will be published in a medical journal sometime during the next two years.
Access Criteria
Will be entered when accepted in a journal.