chronic inflammation of the pancreas with obstruction of the main pancreatic duct. Chronic pancreatitis with obstructive main pancreatic duct stones
Conditions
Interventions
Pancreatoscopy-guided EHL, performed with a digital single-operator
cholangio-pancreaticoscopy system (Spyglass* Direct Visualization System) with
EHL (Nortech AUTOLITH system).
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Age equal to or above 18 years (adult) 3. Symptomatic chronic pancreatitis with obstructive pancreatic duct stones (> 5 mm), in the head or neck of the pancreas.
Exclusion criteria
Exclusion criteria: 1. Inability to give informed consent. 2. Age less than 18 years of age. 3. Chronic pancreatitis with obstructive pancreatic duct stones, located in the body or tail of the pancreas. 4. History of treatment of pancreatic duct stones with ESWL. 5. History of surgical treatment of chronic pancreatitis. 6. Pregnancy. 7. Inability to undergo endoscopic treatment due to comorbidity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the technical success rate of pancreatoscopy-guided EHL (clearance of main pancreatic duct stones). | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints include clinical success (reduction in pain scores and opiate usage), ERCP related complication rates within 30 days of treatment, number of repeat ERPs for stone clearance, length of hospital stay, perceived burden and quality of life, and costs. | — |
Countries
Netherlands
Outcome results
None listed