Pancreatic Diseases
Conditions
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.
Interventions
DEVICEBiodegradable biliary and pancreatic stents placement
Biodegradable biliary and pancreatic stents placement
Sponsors
Istituto Clinico Humanitas
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biodegradation time | 24 Months |
Countries
Italy
Outcome results
None listed