Current treatment of patients with symptomatic chronic pancreatitis (CP) and obstructive main pancreatic duct stones consists of extracorporeal shockwave lithotripsy (ESWL) followed by endoscopic retrograde pancreatography (ERP) to extract the…
ID
Bron
Verkorte titel
Aandoening
Lithotripsy, Pancreatoscopy-guided, Main pancreatic duct stones, Clinical success
Lithotripsie, ERCP, Stenen, Klinisch succes
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
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.
Achtergrond van het onderzoek
In this non-randomized single center prospective cohort study we invastigate the efficacy and safety of pancreatoscopy-guided EHL in patients with symptomatic CP due to obstructive distal main pancreatic duct stones not having undergone previous treatment. The primary endpoint is clinical success.
Doel van het onderzoek
Current treatment of patients with symptomatic chronic pancreatitis (CP) and obstructive main pancreatic duct stones consists of extracorporeal shockwave lithotripsy (ESWL) followed by endoscopic retrograde pancreatography (ERP) to extract the fragmented stones. Pancreatoscopy-guided electrohydraulic lithotripsy has shown potential value CP patients, but is a novel second-line intervention after failed ESWL, due to the necessity of nonstandard equipment and materials. First line intervention with pancreatoscopy-guided electrohydraulic lithotripsy (EHL) could potentially obviate the need for ESWL in selected patients, reducing patient burden, costs and healthcare utilization.
Onderzoeksopzet
Primary and secondary endpoints will be evaluated at day 1, 1 month, 3 months and 6 months after the EHL procedure.
Onderzoeksproduct en/of interventie
Pancreatoscopy-guided EHL, performed with a digital single-operator cholangio-pancreatoscopy system (Spyglass Direct Visualizition System) with EHL (Nortech AUTOLITH system).
Publiek
's Gravendijkwal 230
Erasmus Medisch Centrum Rotterdam, Department of Gastroenterology & Hepatology
Rotterdam 3015 CE
The Netherlands
0628235160
p.dejonge@erasmusmc.nl
Wetenschappelijk
's Gravendijkwal 230
Erasmus Medisch Centrum Rotterdam, Department of Gastroenterology & Hepatology
Rotterdam 3015 CE
The Netherlands
0628235160
p.dejonge@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
- Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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.
- History of surgical treatment of chronic pancreatitis.
- Pregnancy.
- Inability to provide informed consent.
- Inability to undergo endoscopic treatment due to comorbidity.
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL6683 |
| NTR-old | NTR6853 |
| Ander register | METC Erasmus MC : MEC-2017-179 |