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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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, Senior)
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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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
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