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PTFE Stents for Treatment of Malignant Biliary Strictures

Primary Purpose

Bile Duct Stricture, Bile Duct Cancer, Pancreas Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Stenting with PTFE-coated stent (HILZO)
Sponsored by
Johannes Vermehren
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bile Duct Stricture focused on measuring metal stent, biliary stricture, stenting

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Indication for the palliative metal-stent system for malignant stenosis of the distal DHC (bile duct tumors, pancreatic carcinoma, papillary carcinoma, lymphoma, lymph node metastases in the hilum)

Exclusion Criteria:

  • Age under 18 years
  • Pregnancy
  • Contraindication to an endoscopic examination
  • Life expectancy under 3 months

Sites / Locations

  • Klinikum der J. W. Goethe-UniversitätRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Stenting with PTFE-coated stent (HILZO)

Stenting standard silicone coated stent

Arm Description

The bile duct is stented with a PTFE-coated stent by duodenoscopy to allow bile duct flow

The bile duct is stented with a standard silicone-coated stent by duodenoscopy to allow bile duct flow

Outcomes

Primary Outcome Measures

Stent migration
Rate of stent migrations

Secondary Outcome Measures

Stent dysfunction (re-stenosis)
Stenosis of stent with necessity to do duodenoscopy again
Number of ERCPs in one year
Count of the number of duodenoscopy the patients undergo
Survival rate
Survival of patientes 12 month after the procedure

Full Information

First Posted
May 14, 2018
Last Updated
December 1, 2018
Sponsor
Johannes Vermehren
Collaborators
Robert Bosch Medical Center, Klinikum Stadt Hanau
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1. Study Identification

Unique Protocol Identification Number
NCT03763214
Brief Title
PTFE Stents for Treatment of Malignant Biliary Strictures
Official Title
Randomized Comparative Study of Novel PTFE-coated Stents (Hilzo) Versus Standard Silicone-coated Metal Stents (cSEMS) in Distal Malignant DHC Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
September 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Johannes Vermehren
Collaborators
Robert Bosch Medical Center, Klinikum Stadt Hanau

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
In this randomized trial two two self-expanding metal stents (SEMS) for treatment of malignant biliary strictures are investigated. A newly developed PTFE (Polytetrafluorethylen) (Teflon) stent is tested versus standard covered metal stents. PFTE (Teflon) coating promises improved formability over standard silicone-coated stents, easier removal through the soft surface, and significantly reduced tumor growth through the impermeable surface.
Detailed Description
ERCP (endoscopic retrograde cholangiopancreatography) is the standard method of treating diseases in the biliopancreatic system and the treatment goal is achieved in a very high proportion of the studies. The ERCP is based on the indirect imaging of the bile ducts by injection of contrast medium, which is visualized in X-ray fluoroscopy. Furthermore, the probing of the bile ducts by means of wire and direct interventions within the bile duct system is possible. Malignant biliary strictures are caused by various, usually cholangiocellular or pancreatic tumors, whose surgical therapy is complex and often impossible due to advanced disease. Tumors of the papillae, lymphomas and lymph node metastases can also lead to stenosis of the extra hepatic bile ducts. The outcome of patients with malignant biliary strictures is poor, most are already presenting with advanced disease because early symptoms are rare. In particular, the above-mentioned cholangiocellular carcinomas and pancreatic carcinomas are often resectable only in its early form with high recurrence rates. Furthermore, then only palliative concepts are possible. Various studies have shown that stenting of the biliary tract with drainage of more than 50% of the liver volume improves survival. Metal stents seem to be superior to plastic stents at a slightly higher cholangitis rate. It is therefore considered standard therapy to palliatively treat these patients with more than 3 months of life expectancy using a metal stent. Two types of stents are currently in use, plastic stents and self-expanding metal stents (SEMS). These in turn are coated (cSEMS) and uncoated (uSEMS). In distal malignant stenosis, both cSEMS and uSEMS can be used, with a higher patency rate for cSEMS and a longer duration of uSEMS retention. The disadvantage of the uSEMS is the tumor ingrowth in the stents and the possibility of re-stenosis. Various studies have shown that metal stents are associated with better bile duct drainage and better retention time compared to plastic stents and have fewer early complications, however, a consensus regarding a survival advantage with metal stents has not yet been substantiated, with the data showing a positive trend. Since metal stents, unlike plastic stents, do not need to be changed, a significant advantage for the patient is the significant reduction in endoscopic examinations and associated hospitalization and complication rates. PTFE stents are a new development that should significantly reduce tumor ingrowth into the stent and, in particular, allow for a significantly reduced stent migration rate. PFTE (Teflon) coating promises improved formability over standard silicone-coated stents, easier removal through the soft surface, and significantly reduced tumor growth through the impermeable surface. At both ends of the stents are "tulips" which are coated with silicone. This in turn reduces the rate of stent closure by sludge, and in particular, the otherwise very high rate of stent migration should be significantly reduced.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bile Duct Stricture, Bile Duct Cancer, Pancreas Cancer
Keywords
metal stent, biliary stricture, stenting

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized, two arms
Masking
None (Open Label)
Allocation
Randomized
Enrollment
64 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stenting with PTFE-coated stent (HILZO)
Arm Type
Experimental
Arm Description
The bile duct is stented with a PTFE-coated stent by duodenoscopy to allow bile duct flow
Arm Title
Stenting standard silicone coated stent
Arm Type
Active Comparator
Arm Description
The bile duct is stented with a standard silicone-coated stent by duodenoscopy to allow bile duct flow
Intervention Type
Device
Intervention Name(s)
Stenting with PTFE-coated stent (HILZO)
Intervention Description
Placing a metal stent in the biliary tract by duodenoscopy
Primary Outcome Measure Information:
Title
Stent migration
Description
Rate of stent migrations
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Stent dysfunction (re-stenosis)
Description
Stenosis of stent with necessity to do duodenoscopy again
Time Frame
12 month
Title
Number of ERCPs in one year
Description
Count of the number of duodenoscopy the patients undergo
Time Frame
12 month
Title
Survival rate
Description
Survival of patientes 12 month after the procedure
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Indication for the palliative metal-stent system for malignant stenosis of the distal DHC (bile duct tumors, pancreatic carcinoma, papillary carcinoma, lymphoma, lymph node metastases in the hilum) Exclusion Criteria: Age under 18 years Pregnancy Contraindication to an endoscopic examination Life expectancy under 3 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mireen Friedrich-Rust, Prof.
Phone
069-6301-0
Email
mireen.friedrich-rust@kgu.de
First Name & Middle Initial & Last Name or Official Title & Degree
Fabian Finkelmeier, Dr.
Phone
069-6301-0
Email
fabian.finkelmeier@kgu.de
Facility Information:
Facility Name
Klinikum der J. W. Goethe-Universität
City
Frankfurt am Main
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mireen Friedrich-Rust, MD
Email
Mireen.Friedrich-Rust@kgu.de

12. IPD Sharing Statement

Learn more about this trial

PTFE Stents for Treatment of Malignant Biliary Strictures

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