No registrations found.
ID
Source
Brief title
Health condition
Lithotripsy, Pancreatoscopy-guided, Main pancreatic duct stones, Clinical success
Lithotripsie, ERCP, Stenen, Klinisch succes
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
1. To evaluate the clinical success of pancreatoscopy-guided EHL, defined as reduction in pain scores and opiate usage.
2. To evaluate the safety profile of pancreatoscopy-guided EHL.
3. To assess the need for hospitalization for pain and/or a flares of chronic pancreatitis.
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.
5. To evaluate the perceived burden and quality-of-life (QoL).
6. To evaluate health resources utilizations / direct medical costs.
Background summary
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.
Study objective
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.
Study design
Primary and secondary endpoints will be evaluated at day 1, 1 month, 3 months and 6 months after the EHL procedure.
Intervention
Pancreatoscopy-guided EHL, performed with a digital single-operator cholangio-pancreatoscopy system (Spyglass Direct Visualizition System) with EHL (Nortech AUTOLITH system).
's Gravendijkwal 230
Erasmus Medisch Centrum Rotterdam, Department of Gastroenterology & Hepatology
Rotterdam 3015 CE
The Netherlands
0628235160
p.dejonge@erasmusmc.nl
's Gravendijkwal 230
Erasmus Medisch Centrum Rotterdam, Department of Gastroenterology & Hepatology
Rotterdam 3015 CE
The Netherlands
0628235160
p.dejonge@erasmusmc.nl
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.
- Written informed consent.
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.
- History of surgical treatment of chronic pancreatitis.
- Pregnancy.
- Inability to provide informed consent.
- Inability to undergo endoscopic treatment due to comorbidity.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6683 |
| NTR-old | NTR6853 |
| Other | METC Erasmus MC : MEC-2017-179 |