Metal Stents (Moving Cell Stent) for Inoperable Tumors of the Bile Duct Tract
NCT ID: NCT03788655
Last Updated: 2018-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
30 participants
OBSERVATIONAL
2018-12-31
2021-06-30
Brief Summary
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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.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Pregnancy
* Contraindication to an endoscopic examination
* Life expectancy under 3 months
18 Years
100 Years
ALL
No
Sponsors
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Klinikum Stadt Hanau
OTHER
Johannes Vermehren
OTHER
Responsible Party
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Johannes Vermehren
Record Keeper, Clinical Professor
Principal Investigators
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Mireen Friedrich-Rust, Prof.
Role: PRINCIPAL_INVESTIGATOR
University Clinic Frankfurt am Main
Locations
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Klinikum der J. W. Goethe-Universität
Frankfurt am Main, , Germany
Countries
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Central Contacts
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Facility Contacts
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Mireen Friedrich-Rust, Prof.
Role: primary
Other Identifiers
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JWGUHMED1-010
Identifier Type: -
Identifier Source: org_study_id