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PELstone Study: Pancreatoscopy-guided electrohydraulic lithotripsy for the treatment of obstructive distal main pancreatic duct stones.


- candidate number28272
- NTR NumberNTR6853
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR29-nov-2017
- Secondary IDsMEC-2017-179  METC Erasmus MC
- Public TitlePELstone Study: Pancreatoscopy-guided electrohydraulic lithotripsy for the treatment of obstructive distal main pancreatic duct stones.
- Scientific TitlePancreatoscopy-guided electrohydraulic lithotripsy for the treatment of obstructive distal main pancreatic duct stones; a clinical outcome and cost evaluation-effectiveness study.
- ACRONYMPELstone Study
- hypothesisCurrent 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.
- Healt Condition(s) or Problem(s) studiedLithotripsy, Pancreatoscopy-guided, Main pancreatic duct stones
- Inclusion criteria- Male or female 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.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- group[default]
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-dec-2017
- planned closingdate1-mei-2019
- Target number of participants25
- InterventionsPancreatoscopy-guided EHL, performed with a digital single-operator cholangio-pancreatoscopy system (Spyglass Direct Visualizition System) with EHL (Nortech AUTOLITH system).
- Primary outcomeTo 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 outcome1. 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.
- TimepointsPrimary and secondary endpoints will be evaluated at day 1, 1 month, 3 months and 6 months after the EHL procedure.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIESMD P.J.F. de Jonge
- CONTACT for SCIENTIFIC QUERIESMD P.J.F. de Jonge
- Sponsor/Initiator Erasmus University Medical Center
- Funding
(Source(s) of Monetary or Material Support)
Boston Scientific
- Publicationsn/a
- Brief summaryIn 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.
- Main changes (audit trail)
- RECORD29-nov-2017 - 12-dec-2017


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