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
1 other identifier
observational
30
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Dec 2018
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 25, 2018
CompletedFirst Posted
Study publicly available on registry
December 27, 2018
CompletedStudy Start
First participant enrolled
December 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedDecember 27, 2018
December 1, 2018
1.9 years
December 25, 2018
December 25, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Technical feasibility of intrahepatic stenting
Successful biliary drainage by new stent
12 month
Secondary Outcomes (5)
Number of drained segments
12
Length of intervention
12 month
Stent dysfunction
12 month
Number of necessary endoscopies per year
12 month
Survival rate
12 month
Eligibility Criteria
Patients with the indication for palliative stenting of the bile duct system due to non-operable Klatskin tumors type II-IV
You may qualify if:
- Indication for the palliative metal-stent system for malignant stenosis due to biliary cancer (Klatskin tumor).
You may not qualify if:
- Age under 18 years
- Pregnancy
- Contraindication to an endoscopic examination
- Life expectancy under 3 months
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Johannes Vermehrenlead
- Klinikum Stadt Hanaucollaborator
Study Sites (1)
Klinikum der J. W. Goethe-Universität
Frankfurt am Main, 60590, Germany
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mireen Friedrich-Rust, Prof.
University Clinic Frankfurt am Main
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Record Keeper, Clinical Professor
Study Record Dates
First Submitted
December 25, 2018
First Posted
December 27, 2018
Study Start
December 31, 2018
Primary Completion
December 1, 2020
Study Completion
June 1, 2021
Last Updated
December 27, 2018
Record last verified: 2018-12