Status:
COMPLETED
The Archimedes Biodegradable Biliary and Pancreatic Stents
Lead Sponsor:
Istituto Clinico Humanitas
Conditions:
Pancreatic Diseases
Eligibility:
All Genders
18+ years
Brief Summary
This is a prospective, phase II, single-centre, non-randomised, single-arm study, enrolling patients with benign and malignant bilio-pancreatic diseases with an indication to biliary or pancreatic pla...
Eligibility Criteria
Inclusion
- Patients with an indication to position one ore more biliary plastic stents during ERCP
- Patients with an indication to position a pancreatic plastic stent during ERCP
Exclusion
- Age \< 18 y
- Life expectancy \< 1 m,
- Inability to pass a guidewire through stricture
- Contra-indication for endoscopy or interventional radiology
- Presence of partial gastric resection
- Unsigned informing consent form, ICF
- Pregnancy
- Pseudo Klatskin tumors (metastases in the liver hilum) and gallbladder carcinoma
Key Trial Info
Start Date :
February 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
December 31 2020
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03767166
Start Date
February 1 2019
End Date
December 31 2020
Last Update
March 18 2021
Active Locations (1)
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1
Endoscopy Unit, Humanitas Research Hospital
Rozzano, Milano, Italy, 20089