Bile Duct StricturePhase 4NCT01818050
Prospective Evaluation of Stent Patency in Patients With Benign Biliary Obstruction of the Wing Biliary Stent (Viaduct™)
A Phase 4 study testing Liver Function Tests in people with Bile Duct Stricture, run by Stanford University at 1 site in United States.
Trial summary
Endoscopic retrograde cholangiopancreatography (ERCP) with plastic stent placement for resolution of biliary obstruction has been the method of choice for many years. However, stent clogging/obstruction is a major limitation in the management of biliary obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bile Duct Stricture
- What is being tested?
- Liver Function Tests
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2013to Mar 2014
- Phase
- Phase 4
- 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
Who may be able to join
- All patients age 18 or older referred for ERCP for biliary obstruction from stones or benign strictures that have been confirmed based on clinical, laboratory and imaging findings, with an indication for plastic stent placement.
- One or more biliary stents may be placed during the procedure depending on the indication such as a biliary stricture necessitating multiple stent placements for dilation as the standard of care.
- Expected patient survival of at least 90 days
- High likelihood of patient follow-up
- Patient is able to give a written informed consent
- Patient is willing and able to comply with the study procedures.
Who cannot join
- Patients with cholangitis
- Patients with bile leak
- Pregnant patients
- Patients with any contraindication to endoscopic procedure
- Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
- Patients with malignant biliary strictures
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Stanford University Hospital
Palo Alto, California, 94035
Subhas Banerjee, MD, 650-723-2623
Subhas Banerjee, MD
About this study
Endoscopic retrograde cholangiopancreatography (ERCP) with plastic stent placement for resolution of biliary obstruction has been the method of choice for many years. However, stent clogging/obstruction is a major limitation in the management of biliary obstruction. Studies have shown that the conventional tubular type polyethylene stents (CS) with side holes accumulate significant sludge and their mean patency is approximately 90 days.
Thus patients requiring longer term stenting need to undergo stent exchanges every 2-3 months.
Read more
Recently, a stent with a star-shaped cross-section has been developed for biliary applications. This FDA approved biliary Wing stent (WS) (ViaDuct™) is a novel plastic biliary stent that lacks a lumen, and is designed to allow bile to flow on the outside of the stent. The stent which is star shaped in cross section, channels fluid along its winged perimeter. It has been proposed that the winged stent design with a lack of central lumen obviates the risk of luminal occlusion and that the risk of occlusion, given the presence of multiple external drainage channels, is smaller. Longer term biliary drainage without the need for stent exchange should therefore be possible with these stents.
The primary aim of this study is to prospectively evaluate the patency rate of the WS up to 90 days in 50 patients with biliary obstruction due to stones or benign strictures.
Read the detailed description
- Fifty patients that meet all the inclusion criteria and have none of the exclusion criteria will be invited to participate in the study.
- Initial visit:
- Written informed consent will be obtained
- Complete history and physical will be performed and the patients baseline liver function tests and imaging results will be assessed and noted in the case report form.
- Patients gender, date of birth, concomitant medications will be noted.
- Procedure: Patients will then be scheduled for the ERCP procedure with wing biliary stent placement. They will undergo the ERCP as standard of care and the wing biliary stent will be placed for decompression of the obstructed biliary system in situations where stenting is standard of care. One or more biliary stents may be placed during the procedure depending on the indication such as a biliary stricture necessitating multiple stent placements for dilation as the standard of care.
- Bloodwork: Patients will undergo bloodwork (total and direct bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) one week after the procedure. The degree of drop in bilirubin will also be noted. The patients will be then have these labs drawn again at 4, 8 and 12 weeks after the procedure.
- Telephone calls: The patients will be called on the telephone at weeks 2, 4, 6, 8, 10 after the procedure to monitor their clinical status. Patients and family members will be given a contact number to call us immediately if they develop any signs of biliary obstruction such as fever, abdominal pain, jaundice, dark urine or light stools. They will also be instructed to come to the emergency room should they develop fevers.
- Stent removal: At the end of 90 days from the stent placement patients will return for a repeat ERCP for stent removal as the standard of care and further endo-therapy as indicated.
- Stent patency will be calculated from the time of stent insertion up to the end of 90 days. The stent patency rate at 90 days will be the proportion of stents placed that do not occlude over this time period. Stent occlusion will be defined as biochemical or clinical evidence of obstructive jaundice.
- All the continuous and outcome variables (stent obstruction) will be statistically analyzed and stent malfunction rates will be analyzed for the wing stent across the various indications.
- Conditions
- Bile Duct Stricture
- Being tested
- Liver Function Tests
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Liver Function TestsOther
LFTs will be checked periodically after Wing stent placement to evaluate stent patency
| Study group | Role | What they receive |
|---|---|---|
| Wing stent arm | Other | There is only one arm in this study. Intervention: checking liver function tests to evaluate stent patency Receives: Other: Liver Function Tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biliary stent patency
Measured: At 90 days after stent placement
Secondary outcomes (1)
Liver Function Test improvement
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2013 (estimated)
- Study startMar 2013
- Primary completionMar 2014 (estimated)
- Study completionMar 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bile Duct StrictureStudies of the same condition, open and under way.
- More trials run by Stanford 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- GI Supply
- Responsible party
- Sponsor
- Investigators
- Subhas Banerjee, Principal investigator, Stanford UniversityRajan Kochar, MD, Study director, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01818050
- Sponsor's protocol ID
- 21604
- Status last verified
- Apr 2013
- First submitted
- 21 Mar 2013
- Last updated
- 8 Apr 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Schmidt A, Riecken B, Rische S, Klinger C, Jakobs R, Bechtler M, Kahler G, Dormann A, Caca K. Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study. Endoscopy. 2015 May;47(5):430-6. doi: 10.1055/s-0034-1391232. Epub 2015 Jan 15.
PubMed 25590188
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of Stent Patency in Patients With Benign Biliary Obstruction of the Wing Biliary Stent (Viaduct™)
- ClinicalTrials.gov ID
- NCT01818050
- Acronym / sponsor ID
- 21604
- Conditions
- Bile Duct Stricture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- GI Supply
- Study start
- Mar 2013
- Primary completion
- Mar 2014 (estimated)
- Study completion
- Mar 2014 (estimated)
- First posted
- 26 Mar 2013 (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.
Endoscopic retrograde cholangiopancreatography (ERCP) with plastic stent placement for resolution of biliary obstruction has been the method of choice for many years. However, stent clogging/obstruction is a major limitation in the management of biliary obstruction. Studies have shown that the conventional tubular type polyethylene stents (CS) with side holes accumulate significant sludge and their mean patency is approximately 90 days.
Thus patients requiring longer term stenting need to undergo stent exchanges every 2-3 months.
Recently, a stent with a star-shaped cross-section has been developed for biliary applications. This FDA approved biliary Wing stent (WS) (ViaDuct™) is a novel plastic biliary stent that lacks a lumen, and is designed to allow bile to flow on the outside of the stent. The stent which is star shaped in cross section, channels fluid along its winged perimeter. It has been proposed that the winged stent design with a lack of central lumen obviates the risk of luminal occlusion and that the risk of occlusion, given the presence of multiple external drainage channels, is smaller. Longer term biliary drainage without the need for stent exchange should therefore be possible with these stents.
The primary aim of this study is to prospectively evaluate the patency rate of the WS up to 90 days in 50 patients with biliary obstruction due to stones or benign strictures.
Detailed description
- Fifty patients that meet all the inclusion criteria and have none of the exclusion criteria will be invited to participate in the study.
- Initial visit:
- Written informed consent will be obtained
- Complete history and physical will be performed and the patients baseline liver function tests and imaging results will be assessed and noted in the case report form.
- Patients gender, date of birth, concomitant medications will be noted.
- Procedure: Patients will then be scheduled for the ERCP procedure with wing biliary stent placement. They will undergo the ERCP as standard of care and the wing biliary stent will be placed for decompression of the obstructed biliary system in situations where stenting is standard of care. One or more biliary stents may be placed during the procedure depending on the indication such as a biliary stricture necessitating multiple stent placements for dilation as the standard of care.
- Bloodwork: Patients will undergo bloodwork (total and direct bilirubin, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase) one week after the procedure. The degree of drop in bilirubin will also be noted. The patients will be then have these labs drawn again at 4, 8 and 12 weeks after the procedure.
- Telephone calls: The patients will be called on the telephone at weeks 2, 4, 6, 8, 10 after the procedure to monitor their clinical status. Patients and family members will be given a contact number to call us immediately if they develop any signs of biliary obstruction such as fever, abdominal pain, jaundice, dark urine or light stools. They will also be instructed to come to the emergency room should they develop fevers.
- Stent removal: At the end of 90 days from the stent placement patients will return for a repeat ERCP for stent removal as the standard of care and further endo-therapy as indicated.
- Stent patency will be calculated from the time of stent insertion up to the end of 90 days. The stent patency rate at 90 days will be the proportion of stents placed that do not occlude over this time period. Stent occlusion will be defined as biochemical or clinical evidence of obstructive jaundice.
- All the continuous and outcome variables (stent obstruction) will be statistically analyzed and stent malfunction rates will be analyzed for the wing stent across the various indications.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wing stent arm | Other | Other: Liver Function TestsThere is only one arm in this study. Intervention: checking liver function tests to evaluate stent patency |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- All patients age 18 or older referred for ERCP for biliary obstruction from stones or benign strictures that have been confirmed based on clinical, laboratory and imaging findings, with an indication for plastic stent placement.
- One or more biliary stents may be placed during the procedure depending on the indication such as a biliary stricture necessitating multiple stent placements for dilation as the standard of care.
- Expected patient survival of at least 90 days
- High likelihood of patient follow-up
- Patient is able to give a written informed consent
Key exclusion criteria (6 listed)
- Patients with cholangitis
- Patients with bile leak
- Pregnant patients
- Patients with any contraindication to endoscopic procedure
- Participation in another investigational study that may directly or indirectly affect the results of this study within 30 days prior to the initial visit
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 |
|---|---|---|
| Liver Function TestsLFTs will be checked periodically after Wing stent placement to evaluate stent patency | Other | Wing stent arm |
Primary outcome
Biliary stent patency
Time frame: At 90 days after stent placement
1 secondary outcome
Liver Function Test improvement
Time frame: 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2013.
- Derived from this study: PubMed 25590188Schmidt A, Riecken B, Rische S, Klinger C, Jakobs R, Bechtler M, Kahler G, Dormann A, Caca K. Wing-shaped plastic stents vs. self-expandable metal stents for palliative drainage of malignant distal biliary obstruction: a randomized multicenter study. Endoscopy. 2015 May;47(5):430-6. doi: 10.1055/s-0034-1391232. Epub 2015 Jan 15.
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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.
Subhas Banerjee principal investigator
Stanford University
Rajan Kochar, MD study director
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liver Function Tests in people with Bile Duct Stricture, run by Stanford University at 1 site 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 8 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biliary stent patency (time frame: At 90 days after stent placement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01818050, which also lists 1 linked publication.
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 8 Apr 2013.