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The Patency Period of the New Plastic Anti-reflux Biliary Stent

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ClinicalTrials.gov Identifier: NCT01142921
Recruitment Status : Terminated (Issue regarding the stent design)
First Posted : June 14, 2010
Last Update Posted : April 21, 2017
Sponsor:
Information provided by (Responsible Party):
James Yun-wong Lau, Chinese University of Hong Kong

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Pancreatitis Cholangitis Device: Anti-reflux Tannenbaum biliary stent Device: Ordinary Tannenbaum biliary stent Not Applicable

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
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: GERD

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. time-to-occlusion or stent patency period in days [ Time Frame: within 25 weeks of device application ]

Secondary Outcome Measures :
  1. Bleeding associated with endoscopic retrograde cholangiopancreatography (ERCP) and stent placement [ Time Frame: within 25 weeks of device application ]
  2. perforation associated with ERCP and stent placement [ Time Frame: within 25 weeks of device application ]
  3. pancreatitis associated with ERCP and stent placement [ Time Frame: within 25 weeks of device application ]
  4. cholangitis associated with ERCP and stent placement [ Time Frame: within 25 weeks of device application ]
  5. stent migration associated with ERCP and stent placement [ Time Frame: within 25 weeks of device application ]
  6. all cause mortality [ Time Frame: within 25 weeks of device application ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
China
Endoscopy Centre
Hong Kong, China
Sponsors and Collaborators
Chinese University of Hong Kong
Investigators
Principal Investigator: Wai L Quan, Dr. Chinese University of Hong Kong
More Information
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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