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

Bile Duct Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03788655
• Other study ID #: JWGUHMED1-010
• Status: Recruiting
• Start date: December 31, 2018
• Est. completion date: June 2021

Study information

• Verified date: December 2018
• Source: Johann Wolfgang Goethe University Hospital
• Contact: Mireen Friedrich-Rust, Prof.
• Phone: 069-6301-0
• Email: mireen.friedrich-rust[@]kgu.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Bile Duct Cancer
• Bile Duct Neoplasms
• Bile Duct Stricture
• Cholangiocarcinoma
• Constriction, Pathologic

Locations

Country	Name	City	State
Germany	Klinikum der J. W. Goethe-Universität	Frankfurt am Main

Sponsors (2)

Lead Sponsor	Collaborator
Johannes Vermehren	Klinikum Stadt Hanau

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Technical feasibility of intrahepatic stenting	Successful biliary drainage by new stent	12 month
Secondary	Number of drained segments	Number of successful drained liver segments	12
Secondary	Length of intervention	Length of the endoscopy with the new stent	12 month
Secondary	Stent dysfunction	Stent migration or stenosis	12 month
Secondary	Number of necessary endoscopies per year	Number of necessary endoscopies per year to have successful drainage	12 month
Secondary	Survival rate	Survival of patients 12 month after the procedure	12 month