The Patency Period of the New Plastic Anti-reflux Biliary Stent
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01142921 |
Recruitment Status
:
Terminated
(Issue regarding the stent design)
First Posted
: June 14, 2010
Last Update Posted
: April 21, 2017
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Pancreatitis Cholangitis | Device: Anti-reflux Tannenbaum biliary stent Device: Ordinary Tannenbaum biliary stent | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Prospective Randomised Study on the Patency Period of the Plastic Anti-reflux Biliary Stent |
Actual Study Start Date : | November 2008 |
Actual Primary Completion Date : | August 2011 |
Actual Study Completion Date : | August 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Ordinary Tannenbaum biliary stent
Ordinary Tannenbaum biliary stent
|
Device: Ordinary Tannenbaum biliary stent
Ordinary Tannenbaum biliary stent
Other Name: ST-2 Soehendra® Tannenbaum® Biliary Stent
|
Experimental: Anti-reflux Tannenbaum biliary stent
Anti-reflux Tannenbaum biliary stent
|
Device: Anti-reflux Tannenbaum biliary stent
Anti-reflux Tannenbaum biliary stent
Other Name: Fusion® Marathon™ Anti-Reflux Biliary Stent
|
- time-to-occlusion or stent patency period in days [ Time Frame: within 25 weeks of device application ]
- 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 ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 99 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01142921
China | |
Endoscopy Centre | |
Hong Kong, China |
Principal Investigator: | Wai L Quan, Dr. | Chinese University of Hong Kong |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | James Yun-wong Lau, Professor, Chinese University of Hong Kong |
ClinicalTrials.gov Identifier: | NCT01142921 History of Changes |
Other Study ID Numbers: |
ARBS |
First Posted: | June 14, 2010 Key Record Dates |
Last Update Posted: | April 21, 2017 |
Last Verified: | April 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Keywords provided by James Yun-wong Lau, Chinese University of Hong Kong:
Stent Occlusion Biliary Bleeding Biliary Perforation |
Additional relevant MeSH terms:
Pancreatitis Cholangitis Pancreatic Diseases |
Digestive System Diseases Bile Duct Diseases Biliary Tract Diseases |