Biliary StrictureSpy PTCNCT06096129
Cholangioscopy With Spyglass DS Using Percutaneous Transhepatic Cholangiography Access
An observational study of Biliary Stricture, run by Copenhagen University Hospital, Rigshospitalet.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Biliary Stricture
- What is being tested?
- Spy PTC
- Type of treatment
- Surgery or procedure
- How many people
- 22 participants
- Where
- No sites listed yet
- Study dates
- Jan 2016to Jul 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: See above
Who may be able to join
- People above the 18 who underwent Spy PTC in this 5 year period
Who cannot join
- People under the age of 18
About this study
Official title: 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.
Read the 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.
- Conditions
- Biliary Stricture
- Being tested
- Spy PTC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spy PTCProcedure or surgery
Percutaneous transhepatic cholangioscopy with SpyGlass DS system
| Study group | Role | What they receive |
|---|---|---|
| Spy PTC | People who had Spy PTC performed Receives: Procedure: Spy PTC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success in terms of finding diagnosis
Success rate of Spy PTC finding diagnosis later verified through histopathology/scans
Measured: baseline, 1 month after the procedure, follow up 4 or more years later
Secondary outcomes (1)
Safety in terms of complications
Number of participants with complications after procedure requiring intervention in general anesthesia
Measured: during the procedure, up to one month after procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study startJan 2016
- Primary completionDec 2021
- Study completionJul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Biliary StrictureStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Trygve Ulvund Solstad, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Michael P Achiam, MD, Ph.D, Study director, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06096129
- Sponsor's protocol ID
- R-21069569
- Acronym
- Spy PTC
- Status last verified
- Oct 2023
- First submitted
- 5 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The plan is to publish the study in a international medical journal.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cholangioscopy With Spyglass DS Using Percutaneous Transhepatic Cholangiography Access: a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT06096129
- Acronym / sponsor ID
- Spy PTC / R-21069569
- Conditions
- Biliary Stricture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2016 (actual)
- Primary completion
- Dec 2021 (actual)
- Study completion
- Jul 2022 (actual)
- First posted
- 23 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spy PTC | – | Procedure: Spy PTCPeople who had Spy PTC performed |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- See above
Key inclusion criteria (1 listed)
- People above the 18 who underwent Spy PTC in this 5 year period
Key exclusion criteria (1 listed)
- People under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spy PTCPercutaneous transhepatic cholangioscopy with SpyGlass DS system | Procedure or surgery | Spy PTC |
Primary outcome
Success in terms of finding diagnosis
Time frame: 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
1 secondary outcome
Safety in terms of complications
Time frame: during the procedure, up to one month after procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Yes. The plan is to publish the study in a international medical journal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael P Achiam, MD, Ph.D study director
Copenhagen University Hospital, Rigshospitalet
Questions about this trial
What is this clinical trial studying?
An observational study of Biliary Stricture, run by Copenhagen University Hospital, Rigshospitalet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success in terms of finding diagnosis (time frame: baseline, 1 month after the procedure, follow up 4 or more years later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.