The Archimedes Biodegradable Biliary and Pancreatic Stents

Istituto Clinico Humanitas30 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Pancreatic Diseases

Interventions

Biodegradable biliary and pancreatic stents placementDEVICE

Biodegradable biliary and pancreatic stents placement

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Endoscopy Unit, Humanitas Research Hospital

Rozzano, Milano, Italy

Outcomes

Primary Outcomes

Biodegradation time

Time frame: 24 Months

Data from ClinicalTrials.gov

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