The Patency Period of the New Plastic Anti-reflux Biliary... | NCT01142921

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

NCT01142921

Sponsor

Chinese University of Hong Kong

Status

Terminated

Last Update Posted

Apr 21, 2017Actual

Enrollment

16Actual

Phase

Not Applicable

Conditions

Pancreatitis
Cholangitis

Interventions

Anti-reflux Tannenbaum biliary stent
Ordinary Tannenbaum biliary stent

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Issue regarding the stent design

Expanded Access Info

Start Date

Nov 2008Actual

Primary Completion Date

Aug 2011Actual

Completion Date

Aug 2011Actual

First Submitted Date

Jun 8, 2010

First Submission Date that Met QC Criteria

Jun 11, 2010

First Posted Date

Jun 14, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2017

Last Update Posted Date

Apr 21, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Anti-reflux Tannenbaum biliary stent	Device	Anti-reflux Tannenbaum biliary stent	Anti-reflux Tannenbaum biliary stent

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Wai L Quan, Dr.	Chinese University of Hong Kong	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Endoscopy Centre		Hong Kong			China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26024583	Derived	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.

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases
D001649	Bile Duct Diseases
D001660	Biliary Tract Diseases

ID	Term
D010195	Pancreatitis
D002761	Cholangitis