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

Primary Purpose

Pancreatitis, Cholangitis

Status
Terminated
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Anti-reflux Tannenbaum biliary stent
Ordinary Tannenbaum biliary stent
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis focused on measuring Stent Occlusion, Biliary Bleeding, Biliary Perforation

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Endoscopy Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Ordinary Tannenbaum biliary stent

Anti-reflux Tannenbaum biliary stent

Arm Description

Ordinary Tannenbaum biliary stent

Anti-reflux Tannenbaum biliary stent

Outcomes

Primary Outcome Measures

time-to-occlusion or stent patency period in days

Secondary Outcome Measures

Bleeding associated with endoscopic retrograde cholangiopancreatography (ERCP) and stent placement
perforation associated with ERCP and stent placement
pancreatitis associated with ERCP and stent placement
cholangitis associated with ERCP and stent placement
stent migration associated with ERCP and stent placement
all cause mortality

Full Information

First Posted
June 8, 2010
Last Updated
April 20, 2017
Sponsor
Chinese University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT01142921
Brief Title
The Patency Period of the New Plastic Anti-reflux Biliary Stent
Official Title
A Prospective Randomised Study on the Patency Period of the Plastic Anti-reflux Biliary Stent
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
Issue regarding the stent design
Study Start Date
November 2008 (Actual)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Cholangitis
Keywords
Stent Occlusion, Biliary Bleeding, Biliary Perforation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ordinary Tannenbaum biliary stent
Arm Type
Active Comparator
Arm Description
Ordinary Tannenbaum biliary stent
Arm Title
Anti-reflux Tannenbaum biliary stent
Arm Type
Experimental
Arm Description
Anti-reflux Tannenbaum biliary stent
Intervention Type
Device
Intervention Name(s)
Anti-reflux Tannenbaum biliary stent
Other Intervention Name(s)
Fusion® Marathon™ Anti-Reflux Biliary Stent
Intervention Description
Anti-reflux Tannenbaum biliary stent
Intervention Type
Device
Intervention Name(s)
Ordinary Tannenbaum biliary stent
Other Intervention Name(s)
ST-2 Soehendra® Tannenbaum® Biliary Stent
Intervention Description
Ordinary Tannenbaum biliary stent
Primary Outcome Measure Information:
Title
time-to-occlusion or stent patency period in days
Time Frame
within 25 weeks of device application
Secondary Outcome Measure Information:
Title
Bleeding associated with endoscopic retrograde cholangiopancreatography (ERCP) and stent placement
Time Frame
within 25 weeks of device application
Title
perforation associated with ERCP and stent placement
Time Frame
within 25 weeks of device application
Title
pancreatitis associated with ERCP and stent placement
Time Frame
within 25 weeks of device application
Title
cholangitis associated with ERCP and stent placement
Time Frame
within 25 weeks of device application
Title
stent migration associated with ERCP and stent placement
Time Frame
within 25 weeks of device application
Title
all cause mortality
Time Frame
within 25 weeks of device application

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wai L Quan, Dr.
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Endoscopy Centre
City
Hong Kong
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
26024583
Citation
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.
Results Reference
derived

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

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