Malignant Tumor of Extrahepatic Bile DuctNCT01514214
Winged Perimeter Versus Traditional Plastic Biliary Stent for Malignant Bile Duct Obstruction
A study testing WInged perimeter biliary stent insertion (Viaduct) and traditional polyethylene stent insertion (Cotton Huibregtse) in people with Malignant Tumor of Extrahepatic Bile Duct, run by University of British Columbia at 2 sites in Canada.
Trial summary
Strictures in the bile duct cause a blockage of flow of bile. This leads to potential problems including jaundice, itch and infection in the bile duct. The usual first step in this situation would be to allow flow of bile by placing a stent across the stricture. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Tumor of Extrahepatic Bile Duct
- What is being tested?
- WInged perimeter biliary stent insertion (Viaduct) and traditional polyethylene stent insertion (Cotton Huibregtse)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 2 sitesCanada
- Study dates
- Jan 2012to Sep 2016
- Phase
- Interventional
- 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
- > 18 years of age
- Bile duct stricture confirmed on cholangiography at ERCP
- Malignant etiology confirmed on histology or cytology
- Duct stricture is > 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts)
Who cannot join
- Unable to obtain consent
- Unable to tolerate procedure
- Hilar strictures
- Known benign biliary strictures and benign strictures confirmed after randomization
- Circumstances where an alternative biliary stent (pigtail stent or metal stent) is deemed critical by the treating Gastroenterologist
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Vancouver General Hospital
Vancouver, British Columbia, V5Z 1M9
St Paul's Hospital
Vancouver, British Columbia, V6Z 2K5
About this study
Official title: A Randomized Trial Comparing a Winged Perimeter Stent and Traditional Polyethylene Plastic Stent in the Management of Malignant Distal Biliary Strictures
Strictures in the bile duct cause a blockage of flow of bile. This leads to potential problems including jaundice, itch and infection in the bile duct. The usual first step in this situation would be to allow flow of bile by placing a stent across the stricture. This is usually done by a special type of endoscopy procedure called an endoscopic retrograde cholangiopancreatography, or ERCP.
The most commonly used stent are made from a plastic material called polyethylene and has a central lumen in which bile drains through it. Health Canada has approved the sale and use of another stent with a winged perimeter (the VIADUCT stent) for placement in bile duct strictures and is used routinely in our hospitals. However, the investigators do not know which stent is better at treating bile duct strictures. In order to determine which stent would be more useful, the VIADUCT stent and the usual polyethylene flanged stent must be studied under carefully controlled circumstances. This will be done by a randomized, subject-blinded study. Other trials in the past have looked at other stents in this way, but this is the first time the VIADUCT stent has been looked at in this manner. The investigators suspect that the design of the VIADUCT stent will allow it to work for a longer period of time compared to the traditional polyethylene stent.
Read the detailed description
Biliary obstruction usually presents with jaundice, pruritis, cholangitis, and steatorrhoea. Strictures which are a common cause of biliary obstruction, may be secondary to benign or malignant conditions. Common benign conditions include chronic pancreatitis, primary sclerosing cholangitis, autoimmune pancreatitis, prior surgery and recurrent pyogenic cholangitis. Cholangiocarcinomas, ampullary and pancreatic tumours are more common causes of malignant biliary obstruction.
The principles of managing biliary strictures are to determine the underlying cause of the stricture, whilst achieving drainage of the biliary tree, initially with the placement of a plastic stent via an endoscopic retrograde cholangiopancreatography (ERCP). Strictures are sampled using biliary brush cytology and/or biliary biopsy to assess for underlying malignancy. Malignant strictures are usually staged for resectability with computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP) and/or endoscopic ultrasound (EUS).
The Viaduct stent (GI Supply, Camp Hill, Pennsylvania, USA) is a unique stent design and has a winged perimeter, which channels flow of bile around the stent, rather than through a central lumen. Theoretically this may enhance flow and biliary drainage, and prevent obstruction. Both polyethylene and Viaduct plastic stents are approved for use by Health Canada for benign and malignant biliary conditions. It is not known whether one stent is superior to the other in maintaining symptomatic relief from bile duct strictures as there have been no studies to date comparing the two stents.
There is limited published data on the Viaduct stent. A pilot study of the winged stent design was published in 2006. Five patients had winged stents inserted and followed for 2 weeks. The were no problems with stent insertion and symptoms of obstruction and jaundice improved over this time. One study published in abstract form retrospectively compared 34 Viaduct stents matched with 240 "conventional" stents over a five year period. There was no statistical difference with stent dysfunction, and a trend towards patency with the Viaduct stent.
The primary aim of this study is to compare the stent patency time in the Viaduct and polyethylene stent groups in subjects with malignant bile duct strictures. The secondary aims are to determine the etiology of stent failure in the two treatment groups, to identify and compare device-related adverse events in the two treatment groups, to identify other patient factors associated with stent failure, and to compare survival between the Viaduct and polyethylene stent groups.
- Being tested
- WInged perimeter biliary stent insertion (Viaduct), traditional polyethylene stent insertion (Cotton Huibregtse)
- Keywords
- ERCP, biliary stricture, viaduct, cancer
- Medical subject headings
- Bile Duct Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WInged perimeter biliary stent insertion (Viaduct)Device
Also called Viaduct Stent
Insertion of a winged perimeter stent. Size to be determined during the ERCP based on findings.
traditional polyethylene stent insertion (Cotton Huibregtse)Device
Also called Cotton Huibregtse Stent
insertion of a traditional polyethylene stent during ERCP, size to be determined depending on findings during ERCP
| Study group | Role | What they receive |
|---|---|---|
| Winged perimeter stent | Active comparator | Patients who receive the Viaduct stent during ERCP Receives: Device: WInged perimeter biliary stent insertion (Viaduct) |
| polyethylene stent arm | Active comparator | Patient who receive the traditional polyethylene stent during ERCP Receives: Device: traditional polyethylene stent insertion (Cotton Huibregtse) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stent patency time
Time to bile duct re-obstruction
Measured: six months post stent insertion
Secondary outcomes (4)
Etiology of stent failure
Usually occlusion or migration
Measured: six months post stent insertion
Compare number of patients with device related adverse events
Comparing both procedural and delayed complications of stents
Measured: six months post stent insertion
Identify patient factors associated with stent failure
Measured: six months post stent insertion
Survival between the two groups
Measurement in months of survival post diagnosis
Measured: six months post stent insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2012 (estimated)
- Study startJan 2012
- Primary completionJun 2015
- Study completionSep 2016
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 Malignant Tumor of Extrahepatic Bile DuctStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Telford, University of British Columbia
- Investigators
- Jennifer J Telford, MD MPH FRCPC, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01514214
- Sponsor's protocol ID
- H10-02829
- Status last verified
- Apr 2018
- First submitted
- 16 Jan 2012
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Raju GS, Sud R, Elfert AA, Enaba M, Kalloo A, Pasricha PJ. Biliary drainage by using stents without a central lumen: a pilot study. Gastrointest Endosc. 2006 Feb;63(2):317-20. doi: 10.1016/j.gie.2005.07.053.
PubMed 16427942
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Trial Comparing a Winged Perimeter Stent and Traditional Polyethylene Plastic Stent in the Management of Malignant Distal Biliary Strictures
- ClinicalTrials.gov ID
- NCT01514214
- Acronym / sponsor ID
- H10-02829
- Keywords
- ERCP, biliary stricture, viaduct, cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Jan 2012 (actual)
- Primary completion
- Jun 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 23 Jan 2012 (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.
Strictures in the bile duct cause a blockage of flow of bile. This leads to potential problems including jaundice, itch and infection in the bile duct. The usual first step in this situation would be to allow flow of bile by placing a stent across the stricture. This is usually done by a special type of endoscopy procedure called an endoscopic retrograde cholangiopancreatography, or ERCP.
The most commonly used stent are made from a plastic material called polyethylene and has a central lumen in which bile drains through it. Health Canada has approved the sale and use of another stent with a winged perimeter (the VIADUCT stent) for placement in bile duct strictures and is used routinely in our hospitals. However, the investigators do not know which stent is better at treating bile duct strictures. In order to determine which stent would be more useful, the VIADUCT stent and the usual polyethylene flanged stent must be studied under carefully controlled circumstances. This will be done by a randomized, subject-blinded study. Other trials in the past have looked at other stents in this way, but this is the first time the VIADUCT stent has been looked at in this manner. The investigators suspect that the design of the VIADUCT stent will allow it to work for a longer period of time compared to the traditional polyethylene stent.
Detailed description
Biliary obstruction usually presents with jaundice, pruritis, cholangitis, and steatorrhoea. Strictures which are a common cause of biliary obstruction, may be secondary to benign or malignant conditions. Common benign conditions include chronic pancreatitis, primary sclerosing cholangitis, autoimmune pancreatitis, prior surgery and recurrent pyogenic cholangitis. Cholangiocarcinomas, ampullary and pancreatic tumours are more common causes of malignant biliary obstruction.
The principles of managing biliary strictures are to determine the underlying cause of the stricture, whilst achieving drainage of the biliary tree, initially with the placement of a plastic stent via an endoscopic retrograde cholangiopancreatography (ERCP). Strictures are sampled using biliary brush cytology and/or biliary biopsy to assess for underlying malignancy. Malignant strictures are usually staged for resectability with computed tomography (CT), magnetic resonance cholangiopancreatography (MRCP) and/or endoscopic ultrasound (EUS).
The Viaduct stent (GI Supply, Camp Hill, Pennsylvania, USA) is a unique stent design and has a winged perimeter, which channels flow of bile around the stent, rather than through a central lumen. Theoretically this may enhance flow and biliary drainage, and prevent obstruction. Both polyethylene and Viaduct plastic stents are approved for use by Health Canada for benign and malignant biliary conditions. It is not known whether one stent is superior to the other in maintaining symptomatic relief from bile duct strictures as there have been no studies to date comparing the two stents.
There is limited published data on the Viaduct stent. A pilot study of the winged stent design was published in 2006. Five patients had winged stents inserted and followed for 2 weeks. The were no problems with stent insertion and symptoms of obstruction and jaundice improved over this time. One study published in abstract form retrospectively compared 34 Viaduct stents matched with 240 "conventional" stents over a five year period. There was no statistical difference with stent dysfunction, and a trend towards patency with the Viaduct stent.
The primary aim of this study is to compare the stent patency time in the Viaduct and polyethylene stent groups in subjects with malignant bile duct strictures. The secondary aims are to determine the etiology of stent failure in the two treatment groups, to identify and compare device-related adverse events in the two treatment groups, to identify other patient factors associated with stent failure, and to compare survival between the Viaduct and polyethylene stent groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Winged perimeter stent | Active comparator | Device: WInged perimeter biliary stent insertion (Viaduct)Patients who receive the Viaduct stent during ERCP |
| polyethylene stent arm | Active comparator | Device: traditional polyethylene stent insertion (Cotton Huibregtse)Patient who receive the traditional polyethylene stent during ERCP |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years of age
- Bile duct stricture confirmed on cholangiography at ERCP
- Malignant etiology confirmed on histology or cytology
- Duct stricture is > 1 cm distal to the biliary hilum (bifurcation of the common hepatic duct into the right and left hepatic ducts)
Key exclusion criteria (5 listed)
- Unable to obtain consent
- Unable to tolerate procedure
- Hilar strictures
- Known benign biliary strictures and benign strictures confirmed after randomization
- Circumstances where an alternative biliary stent (pigtail stent or metal stent) is deemed critical by the treating Gastroenterologist
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 |
|---|---|---|
| WInged perimeter biliary stent insertion (Viaduct)Also: Viaduct StentInsertion of a winged perimeter stent. Size to be determined during the ERCP based on findings. | Device | Winged perimeter stent |
| traditional polyethylene stent insertion (Cotton Huibregtse)Also: Cotton Huibregtse Stentinsertion of a traditional polyethylene stent during ERCP, size to be determined depending on findings during ERCP | Device | polyethylene stent arm |
Primary outcome
Stent patency time
Time frame: six months post stent insertion
Time to bile duct re-obstruction
4 secondary outcomes
Etiology of stent failure
Time frame: six months post stent insertion
Compare number of patients with device related adverse events
Time frame: six months post stent insertion
Identify patient factors associated with stent failure
Time frame: six months post stent insertion
Survival between the two groups
Time frame: six months post stent insertion
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 2 May 2018.
- Background: PubMed 16427942Raju GS, Sud R, Elfert AA, Enaba M, Kalloo A, Pasricha PJ. Biliary drainage by using stents without a central lumen: a pilot study. Gastrointest Endosc. 2006 Feb;63(2):317-20. doi: 10.1016/j.gie.2005.07.053.
- 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.
Jennifer J Telford, MD MPH FRCPC principal investigator
University of British Columbia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WInged perimeter biliary stent insertion (Viaduct) and traditional polyethylene stent insertion (Cotton Huibregtse) in people with Malignant Tumor of Extrahepatic Bile Duct, run by University of British Columbia at 2 sites in Canada.
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 4 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 2 May 2018. 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 Canada. 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?
Stent patency time (time frame: six months post stent insertion). 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 NCT01514214, 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 2 May 2018.