PTFE Stents for Treatment of Malignant Biliary Strictures

Randomized Comparative Study of Novel PTFE-coated Stents (Hilzo) Versus Standard Silicone-coated Metal Stents (cSEMS) in Distal Malignant DHC Stenosis

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.

Study Overview

• Status: Unknown
• Conditions: Bile Duct Cancer; Pancreas Cancer; Bile Duct Stricture
• Intervention / Treatment: Device: Stenting with PTFE-coated stent (HILZO)

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
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Frankfurt am Main, Germany, 60590
    • Recruiting
    • Klinikum der J. W. Goethe-Universität
    • Contact: Mireen Friedrich-Rust, MD; Email: Mireen.Friedrich-Rust@kgu.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stenting with PTFE-coated stent (HILZO); The bile duct is stented with a PTFE-coated stent by duodenoscopy to allow bile duct flow	Device: Stenting with PTFE-coated stent (HILZO); Placing a metal stent in the biliary tract by duodenoscopy
Active Comparator: Stenting standard silicone coated stent; The bile duct is stented with a standard silicone-coated stent by duodenoscopy to allow bile duct flow	Device: Stenting with PTFE-coated stent (HILZO); Placing a metal stent in the biliary tract by duodenoscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stent migration	Rate of stent migrations	12 month

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Johannes Vermehren
• Collaborators: Robert Bosch Medical Center; Klinikum Stadt Hanau

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Anticipated): March 1, 2020
• Study Completion (Anticipated): September 1, 2020

Study Registration Dates

• First Submitted: May 14, 2018
• First Submitted That Met QC Criteria: December 1, 2018
• First Posted (Actual): December 4, 2018

Study Record Updates

• Last Update Posted (Actual): December 4, 2018
• Last Update Submitted That Met QC Criteria: December 1, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: stenting; metal stent; biliary stricture
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Digestive System Neoplasms; Endocrine Gland Neoplasms; Pathological Conditions, Anatomical; Biliary Tract Diseases; Pancreatic Diseases; Bile Duct Diseases; Biliary Tract Neoplasms; Pancreatic Neoplasms; Constriction, Pathologic; Cholangiocarcinoma; Bile Duct Neoplasms
• Other Study ID Numbers: JWGUHMED1-009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No