PancreatitisNCT01142921
The Patency Period of the New Plastic Anti-reflux Biliary Stent
A study testing Anti-reflux Tannenbaum biliary stent and Ordinary Tannenbaum biliary stent in people with Pancreatitis and Cholangitis, run by Chinese University of Hong Kong at 1 site in China.
Trial summary
The aim of this study is to determine the average patency period of the new anti-reflux biliary stent on patients with malignant bile duct strictures and to determine if this stent remains patent for a longer period of time comparing with the ordinary plastic Tannenbaum biliary stent. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pancreatitis, Cholangitis
- What is being tested?
- Anti-reflux Tannenbaum biliary stent and Ordinary Tannenbaum biliary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteChina
- Study dates
- Nov 2008to Aug 2011
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years old
- Patients who have cholangiographic evidence (on ERCP) consistent with a malignant extrahepatic biliary stricture (below bifurcation of the common hepatic duct) who require plastic stenting
- Patients with peri-ampullary tumours, pancreatic tumours, gall bladder cancer and metastatic tumours with suspected extrinsic bile duct compression
- Patients with stent or nasobiliary drain in-situ without previous sphincterotomy will qualify for the study if they satisfy the above inclusion criteria.
Who cannot join
- Patients fit for surgery.
- Patients who have dominant biliary strictures involving the hilum or more proximal biliary segments.
- Previous sphincterotomy.
- Other medical conditions that will result in a life expectancy of less then 3 months (ASA class >4)
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomised Study on the Patency Period of the Plastic Anti-reflux Biliary Stent
The aim of this study is to determine the average patency period of the new anti-reflux biliary stent on patients with malignant bile duct strictures and to determine if this stent remains patent for a longer period of time comparing with the ordinary plastic Tannenbaum biliary stent.
Read the detailed description
Bile duct related cancer is a condition quite commonly seen among Asians. Predisposing conditions for primary bile duct cancer include recurrent infections and autoimmune diseases such as recurrent pyogenic cholangitis (RPC) and primary sclerosing cholangitis (PSC) as well as congenital problem such as choledochal cyst. Peri-ampullary tumour, pancreatic tumour and metastatic tumours with bile duct compression are other causes of bile duct obstruction. As many of these tumours are discovered at a late stage, curative treatment is usually not feasible. Palliative endoscopic stenting of the obstructed biliary system remains the treatment of choice for the majority.
The main problem with endoscopic stenting of the biliary system is the short stent patency period. There are some reports on modifications to plastic biliary stenting method in recent years including changes in stent designs, use of a different material or coating, administrating prophylactic antibiotics and the use of special drugs. All these have failed to show any conclusive effect on the stent patency period.
A preliminary study has demonstrated some promising results in the use of a stent with an anti-reflux property very similar to the stents the investigators are using in this study.
- Conditions
- Pancreatitis, Cholangitis
- Being tested
- Anti-reflux Tannenbaum biliary stent, Ordinary Tannenbaum biliary stent
- Keywords
- Stent Occlusion, Biliary Bleeding, Biliary Perforation
- Medical subject headings
- Pancreatitis, Cholangitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anti-reflux Tannenbaum biliary stentDevice
Also called Fusion® Marathon™ Anti-Reflux Biliary Stent
Anti-reflux Tannenbaum biliary stent
Ordinary Tannenbaum biliary stentDevice
Also called ST-2 Soehendra® Tannenbaum® Biliary Stent
Ordinary Tannenbaum biliary stent
| Study group | Role | What they receive |
|---|---|---|
| Ordinary Tannenbaum biliary stent | Active comparator | Ordinary Tannenbaum biliary stent Receives: Device: Ordinary Tannenbaum biliary stent |
| Anti-reflux Tannenbaum biliary stent | Experimental | Anti-reflux Tannenbaum biliary stent Receives: Device: Anti-reflux Tannenbaum biliary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
time-to-occlusion or stent patency period in days
Measured: within 25 weeks of device application
Secondary outcomes (6)
Bleeding associated with endoscopic retrograde cholangiopancreatography (ERCP) and stent placement
Measured: within 25 weeks of device application
perforation associated with ERCP and stent placement
Measured: within 25 weeks of device application
pancreatitis associated with ERCP and stent placement
Measured: within 25 weeks of device application
cholangitis associated with ERCP and stent placement
Measured: within 25 weeks of device application
stent migration associated with ERCP and stent placement
Measured: within 25 weeks of device application
all cause mortality
Measured: within 25 weeks of device application
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2010 (estimated)
- Study startNov 2008
- Primary completionAug 2011
- Study completionAug 2011
Why it stopped: Issue regarding the stent design
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 PancreatitisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, James Yun-wong Lau, Chinese University of Hong Kong
- Investigators
- Wai L Quan, Dr., Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01142921
- Sponsor's protocol ID
- ARBS
- Status last verified
- Apr 2017
- First submitted
- 8 Jun 2010
- Last updated
- 21 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Leong QW, Shen ML, Au KW, Luo D, Lau JY, Wu JC, Chan FK, Sung JJ. A prospective, randomized study of the patency period of the plastic antireflux biliary stent: an interim analysis. Gastrointest Endosc. 2016 Feb;83(2):387-93. doi: 10.1016/j.gie.2015.04.027. Epub 2015 May 27.
PubMed 26024583
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomised Study on the Patency Period of the Plastic Anti-reflux Biliary Stent
- ClinicalTrials.gov ID
- NCT01142921
- Acronym / sponsor ID
- ARBS
- Conditions
- Pancreatitis, Cholangitis
- Keywords
- Stent Occlusion, Biliary Bleeding, Biliary Perforation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Issue regarding the stent design
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- Nov 2008 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 14 Jun 2010 (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.
The aim of this study is to determine the average patency period of the new anti-reflux biliary stent on patients with malignant bile duct strictures and to determine if this stent remains patent for a longer period of time comparing with the ordinary plastic Tannenbaum biliary stent.
Detailed description
Bile duct related cancer is a condition quite commonly seen among Asians. Predisposing conditions for primary bile duct cancer include recurrent infections and autoimmune diseases such as recurrent pyogenic cholangitis (RPC) and primary sclerosing cholangitis (PSC) as well as congenital problem such as choledochal cyst. Peri-ampullary tumour, pancreatic tumour and metastatic tumours with bile duct compression are other causes of bile duct obstruction. As many of these tumours are discovered at a late stage, curative treatment is usually not feasible. Palliative endoscopic stenting of the obstructed biliary system remains the treatment of choice for the majority.
The main problem with endoscopic stenting of the biliary system is the short stent patency period. There are some reports on modifications to plastic biliary stenting method in recent years including changes in stent designs, use of a different material or coating, administrating prophylactic antibiotics and the use of special drugs. All these have failed to show any conclusive effect on the stent patency period.
A preliminary study has demonstrated some promising results in the use of a stent with an anti-reflux property very similar to the stents the investigators are using in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ordinary Tannenbaum biliary stent | Active comparator | Device: Ordinary Tannenbaum biliary stentOrdinary Tannenbaum biliary stent |
| Anti-reflux Tannenbaum biliary stent | Experimental | Device: Anti-reflux Tannenbaum biliary stentAnti-reflux Tannenbaum biliary stent |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18 years old
- Patients who have cholangiographic evidence (on ERCP) consistent with a malignant extrahepatic biliary stricture (below bifurcation of the common hepatic duct) who require plastic stenting
- Patients with peri-ampullary tumours, pancreatic tumours, gall bladder cancer and metastatic tumours with suspected extrinsic bile duct compression
- Patients with stent or nasobiliary drain in-situ without previous sphincterotomy will qualify for the study if they satisfy the above inclusion criteria.
Key exclusion criteria (5 listed)
- Patients fit for surgery.
- Patients who have dominant biliary strictures involving the hilum or more proximal biliary segments.
- Previous sphincterotomy.
- Other medical conditions that will result in a life expectancy of less then 3 months (ASA class >4)
- Pregnancy
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 |
|---|---|---|
| Anti-reflux Tannenbaum biliary stentAlso: Fusion® Marathon™ Anti-Reflux Biliary StentAnti-reflux Tannenbaum biliary stent | Device | Anti-reflux Tannenbaum biliary stent |
| Ordinary Tannenbaum biliary stentAlso: ST-2 Soehendra® Tannenbaum® Biliary StentOrdinary Tannenbaum biliary stent | Device | Ordinary Tannenbaum biliary stent |
Primary outcome
time-to-occlusion or stent patency period in days
Time frame: within 25 weeks of device application
6 secondary outcomes
Bleeding associated with endoscopic retrograde cholangiopancreatography (ERCP) and stent placement
Time frame: within 25 weeks of device application
perforation associated with ERCP and stent placement
Time frame: within 25 weeks of device application
pancreatitis associated with ERCP and stent placement
Time frame: within 25 weeks of device application
cholangitis associated with ERCP and stent placement
Time frame: within 25 weeks of device application
stent migration associated with ERCP and stent placement
Time frame: within 25 weeks of device application
all cause mortality
Time frame: within 25 weeks of device application
Results and safety
The study was stopped early (reason given: Issue regarding the stent design). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2017.
- Derived from this study: PubMed 26024583Leong QW, Shen ML, Au KW, Luo D, Lau JY, Wu JC, Chan FK, Sung JJ. A prospective, randomized study of the patency period of the plastic antireflux biliary stent: an interim analysis. Gastrointest Endosc. 2016 Feb;83(2):387-93. doi: 10.1016/j.gie.2015.04.027. Epub 2015 May 27.
- 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.
Wai L Quan, Dr. principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anti-reflux Tannenbaum biliary stent and Ordinary Tannenbaum biliary stent in people with Pancreatitis and Cholangitis, run by Chinese University of Hong Kong at 1 site in China.
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: stopped early, as of the sponsor's last update on 21 Apr 2017. 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 China. 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 stopped early (reason given: Issue regarding the stent design). Results are not available in the source record.
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-occlusion or stent patency period in days (time frame: within 25 weeks of device application). 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 NCT01142921, 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 21 Apr 2017.