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The Archimedes Biodegradable Biliary and Pancreatic Stents

Completed
Conditions
Pancreatic Diseases
Registration Number
NCT03767166
Lead Sponsor
Istituto Clinico Humanitas
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 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
30
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Biodegradation time24 Months
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

Endoscopy Unit, Humanitas Research Hospital

🇮🇹

Rozzano, Milano, Italy

Endoscopy Unit, Humanitas Research Hospital
🇮🇹Rozzano, Milano, Italy
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