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

Pancreatoscopy-guided electrohydraulic lithotripsy for the treatment of obstructive distal main pancreatic duct stones; a clinical outcome and cost evaluation-effectiveness study.

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON27159

Enrollment

Registered

2017-11-29

Start date

2017-12-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lithotripsy, Pancreatoscopy-guided, Main pancreatic duct stones, Clinical success Lithotripsie, ERCP, Stenen, Klinisch succes

Interventions

Pancreatoscopy-guided EHL, performed with a digital single-operator cholangio-pancreatoscopy system (Spyglass Direct Visualizition System) with EHL (Nortech AUTOLITH system).

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Contacts

Public ContactP.J.F. de Jonge

p.dejonge@erasmusmc.nl0628235160

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)