Bile Duct StricturesNCT02776709
Feasibility of a Single-operator Peroral Cholangiopancreatioscopy System (SpyGlass)
An observational study of Bile Duct Strictures and Common Bile Duct Stones, run by Northwestern University at 5 sites in United States.
Trial summary
Cholangioscopy, or direct visualization of the bile ducts was first documented in the late 1970s and has made many advances over the last few decades. The advent of mother-baby scopes allowed for both diagnostic and therapeutic procedures, though the early scopes were often fragile, and cumbersome due to the need for… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Bile Duct Strictures, Common Bile Duct Stones
- What is being tested?
- ERCP with cholangioscopy
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- Jul 2015to May 2018
- How long will I take part?
- 6 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Formation of a multi-site prospective database of all patients referred for the evaluation of indeterminate strictures or removal of difficult stones.
Who may be able to join
- All patients referred for the evaluation of indeterminate strictures or removal of difficult stones.
Who cannot join
- All patients who are unable or unwilling to give consent will not be included in this study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
University of Colorado, Denver
Denver, Colorado, 80202
UCLA Medical Center
Los Angeles, California, 90095
Ochsner Medical Center
New Orleans, Louisiana, 70121
University of Utah
Salt Lake City, Utah, 84132
Moffitt Cancer Center
Tampa, Florida, 33612
About this study
Official title: Clinical Feasibility and Efficacy of a New Digital Single-operator Peroral Cholangiopancreatioscopy System: a Multicenter Registry
Cholangioscopy, or direct visualization of the bile ducts was first documented in the late 1970s and has made many advances over the last few decades. The advent of mother-baby scopes allowed for both diagnostic and therapeutic procedures, though the early scopes were often fragile, and cumbersome due to the need for two endoscopists. Ultraslim endoscopes later became popular as a method to digitally view the bile ducts, however, often needed guide-wire or balloon-assistance to allow for cannulation. Other disadvantages of these systems included limited steerability, and poor irrigation capabilities.
The advent of Spyglass, a single-operator peroral cholangioscopy method allowed for a fiberoptic, catheter-based system that could be easily used for diagnostic and therapeutic purposes in the biliary system. However, image quality was often lacking due to the fiberoptic technology. The new digital Spyglass system rectifies this inadequacy by introducing a digital sensor for better image quality, which will allow for better visualization and diagnosis of indeterminate strictures. Furthermore, modification of the scope platform allows for efficient use, reliable directionality of the scope tip, and improved ease of passage of accessories during therapeutic procedures such clearing stones or stent placement.
Read the detailed description
All patients referred for the evaluation of indeterminate strictures or removal of difficult stones will be eligible for enrollment in the consortium. The PI or study coordinator will meet with the patient and discuss the study, its objectives, and obligations with each patient. After full disclosure, informed consent will be obtained.
Upon consent, basic demographics and data from prior procedures (when available) will be recorded. An endoscopist proficient in ERCP, with expertise in cholangioscopy, will perform the procedures using the Spyglass DS system with its associated components including biopsy forceps (SpyBiteTM) and other accessories as necessary. Procedure time, visual findings, number of biopsies taken, pathology, stone location, stone size, and method of stone clearance and adverse events will be recorded on data collection forms and transferred into a centralized password protected database. All patients will be followed for 6-12 months or surgery (stricture cohort) to assess accuracy or stone recurrence rates.
- Conditions
- Bile Duct Strictures, Common Bile Duct Stones
- Being tested
- ERCP with cholangioscopy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERCP with cholangioscopyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Bile duct Stricture | Patients referred for the evaluation of indeterminate strictures. Receives: Procedure: ERCP with cholangioscopy | |
| Common bile duct Stones | Patients referred for the removal of difficult stones. Receives: Procedure: ERCP with cholangioscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone clearance rate
% of complete removal of bile duct stones
Measured: 6 months
Secondary outcomes (1)
Diagnostic accuracy for indeterminate bile duct strictures
Correlation of pathology with surgical specimen or 6month f/u
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2016 (estimated)
- Study startJul 2015
- Primary completionMay 2018
- Study completionMay 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bile Duct StricturesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 0 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Denver, University of California, Los Angeles, H. Lee Moffitt Cancer Center and Research Institute, University of Utah, Ochsner Health System
- Responsible party
- Principal investigator, Sri Komanduri, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02776709
- Sponsor's protocol ID
- STU00201104
- Status last verified
- Dec 2020
- First submitted
- 12 May 2016
- Last updated
- 4 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Feasibility and Efficacy of a New Digital Single-operator Peroral Cholangiopancreatioscopy System: a Multicenter Registry
- ClinicalTrials.gov ID
- NCT02776709
- Acronym / sponsor ID
- STU00201104
- Conditions
- Bile Duct Strictures, Common Bile Duct Stones
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- University of Colorado, Denver, University of California, Los Angeles, H. Lee Moffitt Cancer Center and Research Institute, University of Utah, Ochsner Health System
- Study start
- Jul 2015
- Primary completion
- May 2018 (actual)
- Study completion
- May 2018 (actual)
- First posted
- 18 May 2016 (estimated)
- 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.
Cholangioscopy, or direct visualization of the bile ducts was first documented in the late 1970s and has made many advances over the last few decades. The advent of mother-baby scopes allowed for both diagnostic and therapeutic procedures, though the early scopes were often fragile, and cumbersome due to the need for two endoscopists. Ultraslim endoscopes later became popular as a method to digitally view the bile ducts, however, often needed guide-wire or balloon-assistance to allow for cannulation. Other disadvantages of these systems included limited steerability, and poor irrigation capabilities.
The advent of Spyglass, a single-operator peroral cholangioscopy method allowed for a fiberoptic, catheter-based system that could be easily used for diagnostic and therapeutic purposes in the biliary system. However, image quality was often lacking due to the fiberoptic technology. The new digital Spyglass system rectifies this inadequacy by introducing a digital sensor for better image quality, which will allow for better visualization and diagnosis of indeterminate strictures. Furthermore, modification of the scope platform allows for efficient use, reliable directionality of the scope tip, and improved ease of passage of accessories during therapeutic procedures such clearing stones or stent placement.
Detailed description
All patients referred for the evaluation of indeterminate strictures or removal of difficult stones will be eligible for enrollment in the consortium. The PI or study coordinator will meet with the patient and discuss the study, its objectives, and obligations with each patient. After full disclosure, informed consent will be obtained.
Upon consent, basic demographics and data from prior procedures (when available) will be recorded. An endoscopist proficient in ERCP, with expertise in cholangioscopy, will perform the procedures using the Spyglass DS system with its associated components including biopsy forceps (SpyBiteTM) and other accessories as necessary. Procedure time, visual findings, number of biopsies taken, pathology, stone location, stone size, and method of stone clearance and adverse events will be recorded on data collection forms and transferred into a centralized password protected database. All patients will be followed for 6-12 months or surgery (stricture cohort) to assess accuracy or stone recurrence rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bile duct Stricture | – | Procedure: ERCP with cholangioscopyPatients referred for the evaluation of indeterminate strictures. |
| Common bile duct Stones | – | Procedure: ERCP with cholangioscopyPatients referred for the removal of difficult stones. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Formation of a multi-site prospective database of all patients referred for the evaluation of indeterminate strictures or removal of difficult stones.
Key inclusion criteria (1 listed)
- All patients referred for the evaluation of indeterminate strictures or removal of difficult stones.
Key exclusion criteria (1 listed)
- All patients who are unable or unwilling to give consent will not be included in this study
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 |
|---|---|---|
| ERCP with cholangioscopy | Procedure or surgery | Bile duct Stricture, Common bile duct Stones |
Primary outcome
Stone clearance rate
Time frame: 6 months
% of complete removal of bile duct stones
1 secondary outcome
Diagnostic accuracy for indeterminate bile duct strictures
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bile Duct Strictures and Common Bile Duct Stones, run by Northwestern University at 5 sites in United States.
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: withdrawn, as of the sponsor's last update on 4 Dec 2020. 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. 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 was withdrawn before enrolling participants, so there are no results.
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?
Stone clearance rate (time frame: 6 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 4 Dec 2020.