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
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.
Study Type
Interventional
Primary Outcome
Stent migration
Secondary Outcome
Stent dysfunction (re-stenosis)
Condition
Bile Duct Stricture
Intervention
Stenting with PTFE-coated stent (HILZO)
Study Arms / Comparison Groups
Stenting with PTFE-coated stent (HILZO)
Description: The bile duct is stented with a PTFE-coated stent by duodenoscopy to allow bile duct flow
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
64
Start Date
March 1, 2018
Completion Date
September 2020
Primary Completion Date
March 2020
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
Gender
All
Ages
18 Years - 100 Years
Accepts Healthy Volunteers
No
Contacts
, 069-6301-0, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT03763214
Organization ID
JWGUHMED1-009
Responsible Party
Sponsor-Investigator
Study Sponsor
Johannes Vermehren
Collaborators
Robert Bosch Medical Center
Study Sponsor
, ,
Verification Date
December 2018