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

Completed

• Conditions: chronic inflammation of the pancreas with obstruction of the main pancreatic duct.; Chronic pancreatitis with obstructive main pancreatic duct stones; 10018008

• Registration Number: NL-OMON47888
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 11 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 25

Inclusion Criteria

1. Written informed consent
2. Age equal to or above 18 years (adult)
3. Symptomatic chronic pancreatitis with obstructive pancreatic duct stones (> 5 mm), in the head or neck of the pancreas.

Exclusion Criteria

1. Inability to give informed consent.
2. Age less than 18 years of age.
3. Chronic pancreatitis with obstructive pancreatic duct stones, located in the body or tail of the pancreas.
4. History of treatment of pancreatic duct stones with ESWL.
5. History of surgical treatment of chronic pancreatitis.
6. Pregnancy.
7. Inability to undergo endoscopic treatment due to comorbidity.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary endpoint is the technical success rate of pancreatoscopy-guided EHL<br /><br>(clearance of main pancreatic duct stones). </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>The secondary endpoints include clinical success (reduction in pain scores and<br /><br>opiate usage), ERCP related complication rates within 30 days of treatment,<br /><br>number of repeat ERPs for stone clearance, length of hospital stay, perceived<br /><br>burden and quality of life, and costs. </p><br>