Liver Transplant; ComplicationsNCT03205072
POCS in Liver Transplantation Patients
An observational study of Liver Transplant; Complications, run by Boston Scientific Corporation at 5 sites in 4 countries.
Trial summary
A prospective, multi-center, non-randomized, observational, consecutive case series, which will compare Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) and cholangioscopy with Spy Glass Digital System (DS) procedure at 5-10 centers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Transplant; Complications
- What is being tested?
- Spy Glass DS
- Type of treatment
- Medical device
- How many people
- 42 participants
- Where
- 5 sitesin 4 countries
- Study dates
- 25 Jan 2018to 24 Mar 2022
- How long will I take part?
- 12 Months
- 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: Cadaveric donor or live donor liver transplantation patients referred for ERCP in the setting of a clinical suspicion of post-liver transplant bile duct stricture(s).
Who may be able to join
- Liver transplantation at least 1 month prior to POCS procedure
- Abnormal Liver Function Tests (LFTs) and/or biliary obstructive symptoms
- Prior cross sectional imaging (MRI and/or US and/or CT)
- Suspicion of anastomotic biliary stricture(s)
- Diameter of bile ducts deemed sufficient to accommodate cholangioscopy system based on baseline imaging
- Willing and able to provide a written informed consent to participate in the study
- Willing and able to comply with study procedures and follow-up schedule
Who cannot join
- Contraindication for an ERCP per local standard of practice
- Deemed contraindicated for POCS per local standard of practice
- Prior biliary treatment of biliary anastomotic stricture
- < 18 years old
- Documented life expectancy of less than 12 months.
Trial locations and contacts
5 sites in 4 countries.
5 sites in 4 countries
United States2 sites
New York Presbyterian Hospital CUMC
New York, New York, 10032
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Per-Oral Cholangioscopy in Liver Transplantation Patients
A prospective, multi-center, non-randomized, observational, consecutive case series, which will compare Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) and cholangioscopy with Spy Glass Digital System (DS) procedure at 5-10 centers.
Read the detailed description
The objective of this study is to demonstrate the clinical utility of cholangioscopy with Spy Glass Digital System (DS) in cadaveric donor or live donor liver transplantation patients who are referred for ERCP in the setting of a clinical suspicion of post liver transplant bile duct stricture(s). A secondary study objective is to generate a hypothesis for a randomized controlled trial comparing ERCP alone to ERCP with Per- Oral Cholangioscopy (POCS) in patients referred for ERCP post liver transplantation.
- Conditions
- Liver Transplant; Complications
- Being tested
- Spy Glass DS
- Keywords
- ERCP, Per-Oral Cholangioscopy, Liver Transplantation, Spy Glass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spy Glass DSDevice
The SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller.
| Study group | Role | What they receive |
|---|---|---|
| ERCP & Spy Glass DS | Patients with cadaveric donor or live donor liver transplantation referred for ERCP in the setting of a clinical suspicion of post liver transplant bile duct strictures. Receives: Device: Spy Glass DS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of Per-Oral Cholangioscopy on Patient Management
To evaluate the impact of the addition of POCS to same setting ERCP on the recommended management of post-liver transplantation biliary complications.
Measured: 12 Months
Secondary outcomes (6)
Technical Success
Ability to visualize the duct/lesion of interest and, if applicable, ability to obtain POCS-guided biopsy adequate for histopathology.
Measured: 12 Months
Serious Adverse Events
Serious Adverse Events (SAEs) including severity, onset, time to resolution, required interventions, relatedness to endoscopic devices and/or procedures and hospitalizations.
Measured: 12 Months
Number of biliary re-interventions
Re-interventions may include but are not limited to repeat ERCP, repeat POCS, ultrasonography, stent exchanges, balloon dilations and liver biopsy.
Measured: 12 Months
Patient Management
Confirmation at 3 months and at 12 months that recommended management at the index procedures was adequate.
Measured: 3 and 12 Months
Relationship between endoscopic findings on POCS visualization
Relationship between endoscopic findings on POCS visualization during index procedure and refractory biliary strictures during follow-up.
Measured: 12 Months
Evaluation
Evaluation by surgeon of whether or not POCS impacted patient management post procedure.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2017
- Study start25 Jan 2018
- Primary completion24 Mar 2022
- Study completion24 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Transplant; ComplicationsStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe 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
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 12 Months
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Amrita Sethi, MD, Principal investigator, Columbia UniversityEduardo De Moura, MD, Principal investigator, Hospital das Clinicas University of Sao PauloAdam Slivka, MD, Principal investigator, University of Pittsburgh Medical CenterAndres Cardenas, MD, Principal investigator, Hospital Clinic of BarcelonaMarco Bruno, MD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03205072
- Sponsor's protocol ID
- E7114
- Status last verified
- Jul 2022
- First submitted
- 26 Jun 2017
- Last updated
- 28 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Per-Oral Cholangioscopy in Liver Transplantation Patients
- ClinicalTrials.gov ID
- NCT03205072
- Acronym / sponsor ID
- E7114
- Conditions
- Liver Transplant; Complications
- Keywords
- ERCP, Per-Oral Cholangioscopy, Liver Transplantation, Spy Glass
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- 25 Jan 2018 (actual)
- Primary completion
- 24 Mar 2022 (actual)
- Study completion
- 24 Mar 2022 (actual)
- First posted
- 2 Jul 2017 (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.
A prospective, multi-center, non-randomized, observational, consecutive case series, which will compare Endoscopic Retrograde Cholangiopancreatoscopy (ERCP) and cholangioscopy with Spy Glass Digital System (DS) procedure at 5-10 centers.
Detailed description
The objective of this study is to demonstrate the clinical utility of cholangioscopy with Spy Glass Digital System (DS) in cadaveric donor or live donor liver transplantation patients who are referred for ERCP in the setting of a clinical suspicion of post liver transplant bile duct stricture(s). A secondary study objective is to generate a hypothesis for a randomized controlled trial comparing ERCP alone to ERCP with Per- Oral Cholangioscopy (POCS) in patients referred for ERCP post liver transplantation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ERCP & Spy Glass DS | – | Device: Spy Glass DSPatients with cadaveric donor or live donor liver transplantation referred for ERCP in the setting of a clinical suspicion of post liver transplant bile duct strictures. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cadaveric donor or live donor liver transplantation patients referred for ERCP in the setting of a clinical suspicion of post-liver transplant bile duct stricture(s).
Key inclusion criteria (7 listed)
- Liver transplantation at least 1 month prior to POCS procedure
- Abnormal Liver Function Tests (LFTs) and/or biliary obstructive symptoms
- Prior cross sectional imaging (MRI and/or US and/or CT)
- Suspicion of anastomotic biliary stricture(s)
- Diameter of bile ducts deemed sufficient to accommodate cholangioscopy system based on baseline imaging
Key exclusion criteria (5 listed)
- Contraindication for an ERCP per local standard of practice
- Deemed contraindicated for POCS per local standard of practice
- Prior biliary treatment of biliary anastomotic stricture
- < 18 years old
- Documented life expectancy of less than 12 months.
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 Glass DSThe SpyScope™ DS Access and Delivery Catheter (SpyScope™ DS Catheter) is a sterile, single-use endoscope that enables access and delivery of accessories to targeted pancreaticobiliary anatomy and displays live video when connected to a Spy Glass DS Digital Controller. | Device | ERCP & Spy Glass DS |
Primary outcome
Impact of Per-Oral Cholangioscopy on Patient Management
Time frame: 12 Months
To evaluate the impact of the addition of POCS to same setting ERCP on the recommended management of post-liver transplantation biliary complications.
6 secondary outcomes
Technical Success
Time frame: 12 Months
Serious Adverse Events
Time frame: 12 Months
Number of biliary re-interventions
Time frame: 12 Months
Patient Management
Time frame: 3 and 12 Months
Relationship between endoscopic findings on POCS visualization
Time frame: 12 Months
Evaluation
Time frame: 12 Months
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 28 Jul 2022.
- Individual participant dataSharing planned: No
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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.
Amrita Sethi, MD principal investigator
Columbia University
Eduardo De Moura, MD principal investigator
Hospital das Clinicas University of Sao Paulo
Adam Slivka, MD principal investigator
University of Pittsburgh Medical Center
5 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Transplant; Complications, run by Boston Scientific Corporation at 5 sites in 4 countries.
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 7 inclusion and 5 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 28 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Brazil, Netherlands, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Impact of Per-Oral Cholangioscopy on Patient Management (time frame: 12 Months). 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 28 Jul 2022.