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

NCT01142921 | Terminated

• 1 other identifier: ARBS
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatitis; Cholangitis

Keywords

Stent Occlusion; Biliary Bleeding; Biliary Perforation

Outcome Measures

Primary Outcomes (1)

• time-to-occlusion or stent patency period in days

  within 25 weeks of device application

Secondary Outcomes (6)

• 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

Study Arms (2)

Ordinary Tannenbaum biliary stent

ACTIVE COMPARATOR

Ordinary Tannenbaum biliary stent

Device: Ordinary Tannenbaum biliary stent

Anti-reflux Tannenbaum biliary stent

EXPERIMENTAL

Anti-reflux Tannenbaum biliary stent

Device: Anti-reflux Tannenbaum biliary stent

Interventions

Anti-reflux Tannenbaum biliary stent DEVICE

Anti-reflux Tannenbaum biliary stent

Also known as: Fusion® Marathon™ Anti-Reflux Biliary Stent

Anti-reflux Tannenbaum biliary stent

Ordinary Tannenbaum biliary stent DEVICE

Ordinary Tannenbaum biliary stent

Also known as: ST-2 Soehendra® Tannenbaum® Biliary Stent

Ordinary Tannenbaum biliary stent

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Endoscopy Centre

Hong Kong, China

Location

Related Publications (1)

• 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.

  PMID: 26024583 DERIVED

MeSH Terms

Conditions

Pancreatitis; Cholangitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Bile Duct Diseases; Biliary Tract Diseases

Study Officials

• Wai L Quan, Dr.

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2010
• First Posted: June 14, 2010
• Study Start: November 1, 2008
• Primary Completion: August 1, 2011
• Study Completion: August 1, 2011
• Last Updated: April 21, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)