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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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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

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Pancreatitis Cholangitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Ordinary Tannenbaum biliary stent

Group Type ACTIVE_COMPARATOR

Ordinary Tannenbaum biliary stent

Intervention Type DEVICE

Ordinary Tannenbaum biliary stent

Anti-reflux Tannenbaum biliary stent

Group Type EXPERIMENTAL

Anti-reflux Tannenbaum biliary stent

Intervention Type DEVICE

Anti-reflux Tannenbaum biliary stent

Interventions

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Anti-reflux Tannenbaum biliary stent

Intervention Type DEVICE

Ordinary Tannenbaum biliary stent

Intervention Type DEVICE

Other Intervention Names

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Fusion® Marathon™ Anti-Reflux Biliary Stent ST-2 Soehendra® Tannenbaum® Biliary Stent

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No