|- candidate number||28272|
|- NTR Number||NTR6853|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-nov-2017|
|- Secondary IDs||MEC-2017-179 METC Erasmus MC|
|- Public Title||PELstone Study: Pancreatoscopy-guided electrohydraulic lithotripsy for the treatment of obstructive distal main pancreatic duct stones. |
|- Scientific Title||Pancreatoscopy-guided electrohydraulic lithotripsy for the treatment of obstructive distal main pancreatic duct stones; a clinical outcome and cost evaluation-effectiveness study.|
|- ACRONYM||PELstone Study|
|- hypothesis||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.|
|- Healt Condition(s) or Problem(s) studied||Lithotripsy, Pancreatoscopy-guided, Main pancreatic duct stones|
|- 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.
- Inability to provide informed consent.
- Inability to undergo endoscopic treatment due to comorbidity.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-dec-2017|
|- planned closingdate||1-mei-2019|
|- Target number of participants||25|
|- Interventions||Pancreatoscopy-guided EHL, performed with a digital single-operator cholangio-pancreatoscopy system (Spyglass Direct Visualizition System) with EHL (Nortech AUTOLITH system). |
|- 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.
|- Timepoints||Primary and secondary endpoints will be evaluated at day 1, 1 month, 3 months and 6 months after the EHL procedure. |
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES||MD P.J.F. de Jonge|
|- CONTACT for SCIENTIFIC QUERIES||MD P.J.F. de Jonge|
|- Sponsor/Initiator ||Erasmus University Medical Center|
(Source(s) of Monetary or Material Support)
|- Brief 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. |
|- Main changes (audit trail)|
|- RECORD||29-nov-2017 - 12-dec-2017|