Metal Stents (Moving Cell Stent) for Inoperable Tumors of the Bile Duct Tract

Feasibility Study on Novel Metal Stents (Moving Cell Stent) for Inoperable Tumors of the Bile Duct Tract

In this feasibility study (non-randomized), the applicability of a new "moving cell" biliary stents (by HILZO) in Klatskin tumors (bile duct obstruction) will be investigated.

The HILZO Moving-Cell Stent to be examined here is a non-coated metal stent with a novelty. The meshes have a diameter of 4 mm, which is rather small compared to most other stents. This significantly increases the radial force and thus the stability of the stent. Furthermore, ingrowth by tumors in the stent is difficult. The special feature is that the individual meshes can easily be stretched to 10 mm without changing the stability of the stent. This allows a second stent to pass through the first to another segment of liver.

Study Overview

• Status: Unknown
• Conditions: Bile Duct Cancer; Bile Duct Stricture

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.

The HILZO Moving-Cell Stent to be examined here is a non-coated metal stent with a novelty. The meshes have a diameter of 4 mm, which is rather small compared to most other stents. This significantly increases the radial force and thus the stability of the stent. Furthermore, ingrowth by tumors in the stent is difficult. The special feature is that the individual meshes can easily be stretched to 10 mm without changing the stability of the stent. This allows a second stent to pass through the first to another segment of liver. Previous metal stents could previously only be placed side by side in the common bile duct, thereby limiting the number of stents as a function of the gait and the stents can develop worse in the main course.

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Germany
  • Frankfurt am Main, Germany, 60590
    • Recruiting
    • Klinikum der J. W. Goethe-Universität
    • Contact: Mireen Friedrich-Rust, Prof.; 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

• Sampling Method: Probability Sample

Study Population

Patients with the indication for palliative stenting of the bile duct system due to non-operable Klatskin tumors type II-IV

Description

Inclusion Criteria:

• Indication for the palliative metal-stent system for malignant stenosis due to biliary cancer (Klatskin tumor).

Exclusion Criteria:

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical feasibility of intrahepatic stenting	Successful biliary drainage by new stent	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of drained segments	Number of successful drained liver segments	12
Length of intervention	Length of the endoscopy with the new stent	12 month
Stent dysfunction	Stent migration or stenosis	12 month
Number of necessary endoscopies per year	Number of necessary endoscopies per year to have successful drainage	12 month
Survival rate	Survival of patients 12 month after the procedure	12 month

Collaborators and Investigators

• Sponsor: Johannes Vermehren
• Collaborators: Klinikum Stadt Hanau
• Investigators: Principal Investigator: Mireen Friedrich-Rust, Prof., University Clinic Frankfurt am Main

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): December 31, 2018
• Primary Completion (ANTICIPATED): December 1, 2020
• Study Completion (ANTICIPATED): June 1, 2021

Study Registration Dates

• First Submitted: December 25, 2018
• First Submitted That Met QC Criteria: December 25, 2018
• First Posted (ACTUAL): December 27, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 27, 2018
• Last Update Submitted That Met QC Criteria: December 25, 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; Digestive System Neoplasms; Pathological Conditions, Anatomical; Biliary Tract Diseases; Bile Duct Diseases; Biliary Tract Neoplasms; Constriction, Pathologic; Cholangiocarcinoma; Bile Duct Neoplasms
• Other Study ID Numbers: JWGUHMED1-010

Drug and device information, study documents

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