PELstone Study: Pancreatoscopy-guided electrohydraulic lithotripsy for the treatment of obstructive distal main pancreatic duct stones.
Recruiting
- Conditions
- ithotripsy, Pancreatoscopy-guided, Main pancreatic duct stones, Clinical successLithotripsie, ERCP, Stenen, Klinisch succes
- Registration Number
- NL-OMON27159
- Lead Sponsor
- Erasmus University Medical Center
- Brief Summary
n/a
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 25
Inclusion Criteria
Male or female ¡Ý 18 years old
- Symptomatic chronic pancreatitis with obstructive pancreatic duct stones (> 5 mm), in the head or neck of the pancreas.
Exclusion Criteria
- Chronic pancreatitis with obstructive pancreatic duct stones, located in the body or tail of the pancreas.
- History of treatment of pancreatic duct stones with ESWL.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To investigate the technical success of pancreatoscopy-guided EHL, in casu clearance of main pancreatic duct stones, in patients with symptomatic chronic pancreatitis due to obstructive distal main pancreatic duct stones who did not undergo previous endoscopic or surgical treatment.
- Secondary Outcome Measures
Name Time Method 1. To evaluate the clinical success of pancreatoscopy-guided EHL, defined as reduction in pain scores and opiate usage.<br /><br>2. To evaluate the safety profile of pancreatoscopy-guided EHL.<br /><br>3. To assess the need for hospitalization for pain and/or a flares of chronic pancreatitis.<br /><br>4. To evaluate the total number of ERPs with or without repeat pancreatoscopy-guided EHL to achieve total or partial stone clearance (excluding procedures scheduled for dilatation therapy of a concomitant stricture.<br /><br>5. To evaluate the perceived burden and quality-of-life (QoL).<br /><br>6. To evaluate health resources utilizations / direct medical costs.