Anastomotic Biliary Stricture Post Orthotopic Liver TransplantNCT01151280
WallFlex Biliary Post Liver Transplant IDE Pilot
A study testing WallFlex Biliary Fully Covered Stent in people with Anastomotic Biliary Stricture Post Orthotopic Liver Transplant, run by Boston Scientific Corporation at 2 sites in United States.
Trial summary
The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant (OLT) patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anastomotic Biliary Stricture Post Orthotopic Liver Transplant
- What is being tested?
- WallFlex Biliary Fully Covered Stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2009to Dec 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18 or older
- Post -OLT patients with symptoms of biliary obstruction secondary to anastomotic biliary stricture as assessed by:
- Clinical signs and symptoms including jaundice, abdominal pain, pruritis, and cholangitis
- Abnormal liver function tests (serum bilirubin > 1.5 and/or elevated alkaline phosphatase levels)
- Abnormal imaging on ultrasound, CT scan, or MRCP suggestive of a biliary stricture
- Willingness and ability to comply with the study procedures and provide written informed consent to participate in the study.
Who cannot join
- Roux-en-Y choledochojejunostomy
- Suspected nonanastomotic biliary strictures based on imaging(i.e. multiple strictures, strictures that are longer than 8cm in length, strictures located in the intrahepatic ducts and/or in the donor duct proximal to the site of anastomosis)
- Living donor transplants
- Transplants performed within 30 days (fresh transplants)
- Perforation of any duct within the biliary tree
- Patients with known sensitivity to any components of the stent or delivery system
Show all 14Show fewer
- Patients with malignancy involving the biliary tree (including hepatocellular carcinoma)
- Patients with poor Karnofsky score
- Life expectancy of less than one year
- Inability to pass a guidewire through the strictured area
- Previous biliary metal or multiple plastic stent placement
- Drug-induced or cholestatic hepatitis from an infective cause
- Redundant bile duct that may be treated by temporary placement of stent or conversion to a RouxEnY hepaticojejunostomy
- Choledocholithiasis/biliary "cast" syndrome
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mansour Parsi, MD
Cleveland, Ohio, 44195
Mount Sinai Medical Center
New York, New York, 10017
About this study
Official title: A Multi-Center, Prospective Study the WallFlex Biliary RX Fully Covered Stent for the Treatment of Anastomotic Biliary Strictures in Post Liver Transplant Patients.
The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant (OLT) patients.
- Being tested
- WallFlex Biliary Fully Covered Stent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WallFlex Biliary Fully Covered StentDevice
Investigational device evaluated for the treatment for benign biliary strictures
| Study group | Role | What they receive |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Experimental | All eligible patients entered into the study will be treated with a WallFlex Biliary Fully Covered Stent Receives: Device: WallFlex Biliary Fully Covered Stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stricture Resolution at the Time of Stent Removal.
Stricture resolution is assessed at the time of stent removal. Stricture resolution is confirmed by cholangiogram and/or balloon sweep of the biliary duct. Stent removal can be per-protocol (3 months indwell) or early.
Measured: At 3 months (per protocol removal) or at early removal.
Secondary outcomes (6)
Safety
Safety is being measured by the occurrence, severity, device- and procedure-relatedness of adverse events during stent placement, during stent indwell, at the time of stent removal, and after stent removal.
Unit of measure will be the actual number of adverse events that occurred.
Measured: From enrollment through end of study.
Stent Removability
Stent removability is measured as the ability to successfully remove the stent at initial placement in case of inadequate stent placement, during the stent indwell period in case of stent failure, or at the end of indwell without any clinically significant complications or technical difficulties. A clinically significant complication is defined as a medical event that requires an intervention.
Measured: At 3 months (per protocol removal) or early removal
Technical Success of Stent Placement
Evaluation of technical success of the stent placement defined as the ability to deploy the stent in satisfactory position across the stricture as determined by cholangiogram.
Measured: At stent placement (Day 1)
Effectiveness of Stent at 6 Months
Evaluation of effectiveness of the stent by assessing for resolution of stricture at 6 months as determined by cholangiogram.
"Effectiveness" is defined as the absence of biliary obstructive symptoms after receiving a WallFlex stent.
Subjects received liver function tests at the 1 Month and 6 Month post stent removal follow-up visits and were also assessed for biliary obstructive symptoms.
Measured: From stent removal through 6 months post stent removal follow-up.
Re-intervention Occurrence
Evaluation of the occurrence of re-intervention. Re-intervention is defined as any type of endoscopic, percutaneous, or surgical procedure to improve biliary drainage during stent indwell or through 6 months of follow-up after stent removal.
Measured: 6 months post stent removal
Time to Stent Occlusion
Evidence of stent occlusion
"stent occlusion" was assessed during the stent indwell period (from stent placement procedure through the stent removal procedure. 3 months according to protocol). Subjects received liver function tests at the 48 hour, Week 1, Month 1, and Month 3 stent indwell follow-up visits and were also asked if they were experiencing biliary obstructive symptoms at each visit. If stent occlusion was suspected, imaging and/or endoscopic intervention was performed. One subject experienced stent occlusion at 68 days post stent placement. Time to event data was not generated as not enough events occurred to calculate medial time to event data.
Measured: mean time from stent placement to stent removal for all 10 patients was 91.3 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startOct 2009
- Primary completionOct 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anastomotic Biliary Stricture Post Orthotopic Liver TransplantStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Divyesh Sejpal, M.D., Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151280
- Sponsor's protocol ID
- E7055
- Other IDs
- E7055
- Status last verified
- Nov 2013
- First submitted
- 21 Jun 2010
- Last updated
- 25 Dec 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Center, Prospective Study the WallFlex Biliary RX Fully Covered Stent for the Treatment of Anastomotic Biliary Strictures in Post Liver Transplant Patients.
- ClinicalTrials.gov ID
- NCT01151280
- Acronym / sponsor ID
- E7055
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Oct 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 28 Jun 2010 (estimated)
- Results
- Posted 19 Jul 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to demonstrate effectiveness of the WallFlex Biliary RX Fully Covered Stent for anastomotic biliary strictures in post-orthotopic liver transplant (OLT) patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WallFlex Biliary Fully Covered Stent | Experimental | Device: WallFlex Biliary Fully Covered StentAll eligible patients entered into the study will be treated with a WallFlex Biliary Fully Covered Stent |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older
- Post -OLT patients with symptoms of biliary obstruction secondary to anastomotic biliary stricture as assessed by:
- Willingness and ability to comply with the study procedures and provide written informed consent to participate in the study.
Key exclusion criteria (14 listed)
- Roux-en-Y choledochojejunostomy
- Suspected nonanastomotic biliary strictures based on imaging(i.e. multiple strictures, strictures that are longer than 8cm in length, strictures located in the intrahepatic ducts and/or in the donor duct proximal to the site of anastomosis)
- Living donor transplants
- Transplants performed within 30 days (fresh transplants)
- Perforation of any duct within the biliary tree
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 |
|---|---|---|
| WallFlex Biliary Fully Covered StentInvestigational device evaluated for the treatment for benign biliary strictures | Device | WallFlex Biliary Fully Covered Stent |
Primary outcome
Stricture Resolution at the Time of Stent Removal.
Time frame: At 3 months (per protocol removal) or at early removal.
Stricture resolution is assessed at the time of stent removal. Stricture resolution is confirmed by cholangiogram and/or balloon sweep of the biliary duct. Stent removal can be per-protocol (3 months indwell) or early.
6 secondary outcomes
Safety
Time frame: From enrollment through end of study.
Stent Removability
Time frame: At 3 months (per protocol removal) or early removal
Technical Success of Stent Placement
Time frame: At stent placement (Day 1)
Effectiveness of Stent at 6 Months
Time frame: From stent removal through 6 months post stent removal follow-up.
Re-intervention Occurrence
Time frame: 6 months post stent removal
Time to Stent Occlusion
Time frame: mean time from stent placement to stent removal for all 10 patients was 91.3 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Dec 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.
Divyesh Sejpal, M.D. principal investigator
Icahn School of Medicine at Mount Sinai
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WallFlex Biliary Fully Covered Stent in people with Anastomotic Biliary Stricture Post Orthotopic Liver Transplant, run by Boston Scientific Corporation at 2 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 6 inclusion and 14 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 25 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 19 Jul 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Stricture Resolution at the Time of Stent Removal. (time frame: At 3 months (per protocol removal) or at early removal.). 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 25 Dec 2013; AzTrials last refreshed its copy on 27 Oct 2026.