Pancreas Cancer Clinical Trial
Official title:
Randomized Comparative Study of Novel PTFE-coated Stents (Hilzo) Versus Standard Silicone-coated Metal Stents (cSEMS) in Distal Malignant DHC Stenosis
In this randomized trial two two self-expanding metal stents (SEMS) for treatment of
malignant biliary strictures are investigated.
A newly developed PTFE (Polytetrafluorethylen) (Teflon) stent is tested versus standard
covered metal stents. PFTE (Teflon) coating promises improved formability over standard
silicone-coated stents, easier removal through the soft surface, and significantly reduced
tumor growth through the impermeable surface.
Status | Recruiting |
Enrollment | 64 |
Est. completion date | September 2020 |
Est. primary completion date | March 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 of the distal DHC (bile duct tumors, pancreatic carcinoma, papillary carcinoma, lymphoma, lymph node metastases in the hilum) Exclusion Criteria: - Age under 18 years - Pregnancy - Contraindication to an endoscopic examination - Life expectancy under 3 months |
Country | Name | City | State |
---|---|---|---|
Germany | Klinikum der J. W. Goethe-Universität | Frankfurt am Main |
Lead Sponsor | Collaborator |
---|---|
Johannes Vermehren | Klinikum Stadt Hanau, Robert Bosch Medical Center |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Stent migration | Rate of stent migrations | 12 month | |
Secondary | Stent dysfunction (re-stenosis) | Stenosis of stent with necessity to do duodenoscopy again | 12 month | |
Secondary | Number of ERCPs in one year | Count of the number of duodenoscopy the patients undergo | 12 month | |
Secondary | Survival rate | Survival of patientes 12 month after the procedure | 12 month |
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