The Archimedes Biodegradable Biliary and Pancreatic Stents (ARCHIMEDES)

Istituto Clinico Humanitas

Status: Completed

Conditions: Pancreatic Diseases

Treatments: Device: Biodegradable biliary and pancreatic stents placement

Study type: Observational

Funder types: Other

Identifiers

NCT03767166

2275

Details and patient eligibility

About

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 plastic stent positioning during ERCP.

On procedure day, the study team will confirm that the patient meets all the inclusion criteria and none of the exclusion criteria.

The patient will undergo the ABS insertion and monitored and follow-up accordingly to biodegration variant.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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