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

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.

Study Overview

• Status: Terminated
• Conditions: Pancreatitis; Cholangitis
• Intervention / Treatment: Device: Ordinary Tannenbaum biliary stent; Device: Anti-reflux 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 Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hong Kong, China
    • Endoscopy centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Ordinary Tannenbaum biliary stent	Device: Ordinary Tannenbaum biliary stent; Ordinary Tannenbaum biliary stent; Other Names: ST-2 Soehendra® Tannenbaum® Biliary Stent
EXPERIMENTAL: Anti-reflux Tannenbaum biliary stent	Device: Anti-reflux Tannenbaum biliary stent; Anti-reflux Tannenbaum biliary stent; Other Names: Fusion® Marathon™ Anti-Reflux Biliary Stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
time-to-occlusion or stent patency period in days	within 25 weeks of device application

Secondary Outcome Measures

Outcome Measure	Time Frame
Bleeding associated with endoscopic retrograde cholangiopancreatography (ERCP) and stent placement	within 25 weeks of device application
perforation associated with ERCP and stent placement	within 25 weeks of device application
pancreatitis associated with ERCP and stent placement	within 25 weeks of device application
cholangitis associated with ERCP and stent placement	within 25 weeks of device application
stent migration associated with ERCP and stent placement	within 25 weeks of device application
all cause mortality	within 25 weeks of device application

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong
• Investigators: Principal Investigator: Wai L Quan, Dr., Chinese University of Hong Kong

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 1, 2008
• Primary Completion (ACTUAL): August 1, 2011
• Study Completion (ACTUAL): August 1, 2011

Study Registration Dates

• First Submitted: June 8, 2010
• First Submitted That Met QC Criteria: June 11, 2010
• First Posted (ESTIMATE): June 14, 2010

Study Record Updates

• Last Update Posted (ACTUAL): April 21, 2017
• Last Update Submitted That Met QC Criteria: April 20, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Stent Occlusion; Biliary Bleeding; Biliary Perforation
• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Pancreatic Diseases; Bile Duct Diseases; Pancreatitis; Cholangitis
• Other Study ID Numbers: ARBS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO