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

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ClinicalTrials.gov Identifier: NCT03788655
Recruitment Status : Recruiting
First Posted : December 27, 2018
Last Update Posted : December 27, 2018
Sponsor:
Collaborator:
Klinikum Stadt Hanau
Information provided by (Responsible Party):
Johannes Vermehren, Johann Wolfgang Goethe University Hospital

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.


Condition or disease
Bile Duct Stricture Bile Duct Cancer

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.


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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Feasibility Study on Novel Metal Stents (Moving Cell Stent) for Inoperable Tumors of the Bile Duct Tract
Estimated Study Start Date : December 31, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. Technical feasibility of intrahepatic stenting [ Time Frame: 12 month ]
    Successful biliary drainage by new stent


Secondary Outcome Measures :
  1. Number of drained segments [ Time Frame: 12 ]
    Number of successful drained liver segments

  2. Length of intervention [ Time Frame: 12 month ]
    Length of the endoscopy with the new stent

  3. Stent dysfunction [ Time Frame: 12 month ]
    Stent migration or stenosis

  4. Number of necessary endoscopies per year [ Time Frame: 12 month ]
    Number of necessary endoscopies per year to have successful drainage

  5. Survival rate [ Time Frame: 12 month ]
    Survival of patients 12 month after the procedure



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03788655


Contacts
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Contact: Mireen Friedrich-Rust, Prof. 069-6301-0 mireen.friedrich-rust@kgu.de
Contact: Fabian Finkelmeier, Dr. 069-6301-0 fabian.finkelmeier@kgu.de

Locations
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Germany
Klinikum der J. W. Goethe-Universität Recruiting
Frankfurt am Main, Germany, 60590
Contact: Mireen Friedrich-Rust, Prof.       Mireen.Friedrich-Rust@kgu.de   
Sponsors and Collaborators
Johannes Vermehren
Klinikum Stadt Hanau
Investigators
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Principal Investigator: Mireen Friedrich-Rust, Prof. University Clinic Frankfurt am Main

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Responsible Party: Johannes Vermehren, Record Keeper, Clinical Professor, Johann Wolfgang Goethe University Hospital
ClinicalTrials.gov Identifier: NCT03788655     History of Changes
Other Study ID Numbers: JWGUHMED1-010
First Posted: December 27, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Johannes Vermehren, Johann Wolfgang Goethe University Hospital:
metal stent
biliary stricture
stenting

Additional relevant MeSH terms:
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Cholangiocarcinoma
Constriction, Pathologic
Bile Duct Neoplasms
Pathological Conditions, Anatomical
Biliary Tract Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Bile Duct Diseases
Biliary Tract Diseases
Digestive System Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type