Inoperable Tumors of the Bile DuctWallstentNCT01047332
A Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
A study testing Partially Covered Wallstent and Uncovered Wallstent in people with Inoperable Tumors of the Bile Duct, run by Brigham and Women's Hospital.
Trial summary
The purpose of the study is to determine the best management of bile duct narrowing (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the liver to the small bowel to digest fats. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inoperable Tumors of the Bile Duct
- What is being tested?
- Partially Covered Wallstent and Uncovered Wallstent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- No sites listed yet
- Study dates
- Oct 2002to Nov 2009
- 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
- ≥ 18 years of age.
- Malignant bile duct stricture.
- Increased bilirubin.
- Duct stricture is ≥ 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts).
- Not an operative candidate.
Who cannot join
- Unable to obtain consent.
- Unable to tolerate procedure.
- Suspected benign bile duct stricture.
- Candidate for potentially curative surgical intervention.
- Previous metallic biliary stent.
- Previous bile duct surgery.
About this study
Official title: A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
The purpose of the study is to determine the best management of bile duct narrowing (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the liver to the small bowel to digest fats. Tumors around the bile duct can compress the duct causing pain, jaundice (yellow skin and eyes), itchy skin and fever.
Read the detailed description
This is a prospective randomized trial conducted at 4 large teaching hospitals (Brigham and Women's Hospital, Massachusetts General Hospital, and Boston Medical Center, Boston, Massachusetts, and Mayo Clinic, Rochester, Minnesota).
Malignancy is determined by pathology. Cancer stage is determined by transabdominal imaging and/or endoscopic ultrasound (EUS). Written informed consent is obtained from each of the enrolled patients. The study is approved by the Institutional Review Boards at each of the participating centers.
- Conditions
- Inoperable Tumors of the Bile Duct
- Being tested
- Partially Covered Wallstent, Uncovered Wallstent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Partially Covered WallstentDevice
Partially covered wallstent
Uncovered WallstentDevice
Uncovered wallstent
| Study group | Role | What they receive |
|---|---|---|
| Uncovered Wallstent | Active comparator | Endoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type). Receives: Device: Uncovered Wallstent |
| Partially Covered Wallstent | Experimental | Endoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type). Receives: Device: Partially Covered Wallstent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Recurrent Biliary Obstruction
Biliary obstruction is the narrowing (stricture) of the bile duct. This narrowing prevents bile, which is formed in the liver, from being carried to the small bowel to digest fats. Symptoms of biliary obstruction are pain, jaundice (yellow skin and eyes), itchy skin and fever. Time to biliary obstruction is defined as the time from the placement of the stent to the time of biliary obstruction as reported by the participant via monthly interview questions or call to a pager if symptoms of recurrent biliary obstruction developed. Participants not experiencing recurrent biliary obstruction were censored at the date of last follow-up or date of death.
Measured: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
Secondary outcomes (3)
Patient Survival
Patient survival is defined as the date of the placement of the stent to the date of death. Participants lost to follow-up were analyzed in an intention-to-treat fashion and censored at the time of their last follow-up interview.
Measured: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
Number of Participants With Serious Adverse Events (SAEs)
Serious adverse events were defined as adverse events requiring an invasive procedure or hospitalization or resulting in death.
Measured: From time of stent placement to participant death or lost to follow-up (up to 1302 days)
Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism
Mechanisms of recurrent biliary obstructions are defined as tumor ingrowth, tumor overgrowth, stent migration, sludge, food debris, stent failed to expand and unknown. Stents may be obstructed by more than one mechanism, therefore, the total does not add up to the number of stent obstructions in each group.
Measured: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startOct 2002
- Primary completionMay 2008
- Study completionNov 2009
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Inoperable Tumors of the Bile DuctStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Principal investigator, David L. Carr-Locke, MD, FRCP, Brigham and Women's Hospital
- Investigators
- David L Carr-Locke, MD, FRCP, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01047332
- Sponsor's protocol ID
- BS-816
- Acronym
- Wallstent
- Status last verified
- Feb 2017
- First submitted
- 8 Jan 2010
- Last updated
- 11 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Telford JJ, Carr-Locke DL, Baron TH, Poneros JM, Bounds BC, Kelsey PB, Schapiro RH, Huang CS, Lichtenstein DR, Jacobson BC, Saltzman JR, Thompson CC, Forcione DG, Gostout CJ, Brugge WR. A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction. Gastrointest Endosc. 2010 Nov;72(5):907-14. doi: 10.1016/j.gie.2010.08.021.
PubMed 21034891
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing the Uncovered to the Covered Wallstent in the Palliation of Malignant Bile Duct Strictures
- ClinicalTrials.gov ID
- NCT01047332
- Acronym / sponsor ID
- Wallstent / BS-816
- Conditions
- Inoperable Tumors of the Bile Duct
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- Oct 2002 (actual)
- Primary completion
- May 2008 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Posted 11 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to determine the best management of bile duct narrowing (stricture) due to inoperable tumors. The bile duct is a tube that carries bile formed in the liver to the small bowel to digest fats. Tumors around the bile duct can compress the duct causing pain, jaundice (yellow skin and eyes), itchy skin and fever.
Detailed description
This is a prospective randomized trial conducted at 4 large teaching hospitals (Brigham and Women's Hospital, Massachusetts General Hospital, and Boston Medical Center, Boston, Massachusetts, and Mayo Clinic, Rochester, Minnesota).
Malignancy is determined by pathology. Cancer stage is determined by transabdominal imaging and/or endoscopic ultrasound (EUS). Written informed consent is obtained from each of the enrolled patients. The study is approved by the Institutional Review Boards at each of the participating centers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Uncovered Wallstent | Active comparator | Device: Uncovered WallstentEndoscopically-placed biliary self-expanding metal stent (SEMS) (uncovered type). |
| Partially Covered Wallstent | Experimental | Device: Partially Covered WallstentEndoscopically-placed biliary self-expanding metal stent (SEMS) (partially covered type). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ≥ 18 years of age.
- Malignant bile duct stricture.
- Increased bilirubin.
- Duct stricture is ≥ 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts).
- Not an operative candidate.
Key exclusion criteria (6 listed)
- Unable to obtain consent.
- Unable to tolerate procedure.
- Suspected benign bile duct stricture.
- Candidate for potentially curative surgical intervention.
- Previous metallic biliary stent.
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 |
|---|---|---|
| Partially Covered WallstentPartially covered wallstent | Device | Partially Covered Wallstent |
| Uncovered WallstentUncovered wallstent | Device | Uncovered Wallstent |
Primary outcome
Time to Recurrent Biliary Obstruction
Time frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
Biliary obstruction is the narrowing (stricture) of the bile duct. This narrowing prevents bile, which is formed in the liver, from being carried to the small bowel to digest fats. Symptoms of biliary obstruction are pain, jaundice (yellow skin and eyes), itchy skin and fever. Time to biliary obstruction is defined as the time from the placement of the stent to the time of biliary obstruction as reported by the participant via monthly interview questions or call to a pager if symptoms of recurrent biliary obstruction developed. Participants not experiencing recurrent biliary obstruction were censored at the date of last follow-up or date of death.
3 secondary outcomes
Patient Survival
Time frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From time of stent placement to participant death or lost to follow-up (up to 1302 days)
Number of Participants With Recurrent Biliary Obstruction Reported by Mechanism
Time frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21034891Telford JJ, Carr-Locke DL, Baron TH, Poneros JM, Bounds BC, Kelsey PB, Schapiro RH, Huang CS, Lichtenstein DR, Jacobson BC, Saltzman JR, Thompson CC, Forcione DG, Gostout CJ, Brugge WR. A randomized trial comparing uncovered and partially covered self-expandable metal stents in the palliation of distal malignant biliary obstruction. Gastrointest Endosc. 2010 Nov;72(5):907-14. doi: 10.1016/j.gie.2010.08.021.
- Individual participant dataSharing planned: No
Related trials for Inoperable Tumors of the Bile Duct
Not yet recruiting
Improving a Bile Duct Drainage Procedure in Patients With Inoperable Cancer Blocking the Bile Ducts: Comparing Two Types of Endoscopically Placed Internal Stents to Prevent Blockage of a Lumen Apposing Metal Stent
Malignant Biliary Obstruction, Advanced Pancreatic Cancer and Cholangiocarcinoma
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.
David L Carr-Locke, MD, FRCP principal investigator
Brigham and Women's Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Partially Covered Wallstent and Uncovered Wallstent in people with Inoperable Tumors of the Bile Duct, run by Brigham and Women's Hospital.
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 5 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: finished, as of the sponsor's last update on 11 Apr 2017. 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?
Yes. Results are posted in the registry (first posted 11 Apr 2017). 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?
Time to Recurrent Biliary Obstruction (time frame: Median follow-up of 125 days in the uncovered SEMS arm and 201 days in the partially covered SEMS arm). 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 NCT01047332, 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 11 Apr 2017.