Safety and Efficacy of ESWL for Geriatric Patients With Chronic Pancreatitis

Study Overview
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Brief Summary
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Pancreatic extracorporeal shock wave lithotripsy (P-ESWL) is recommended as the first-line treatment for pancreatic stones. However, how well P-ESWL performs in geriatric patients remains unclear. The investigators aimed to evaluate the safety and efficacy of P-ESWL for geriatric patients with chronic pancreatitis.

Detailed Description
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This prospective observational study was conducted in patients with painful chronic pancreatitis who underwent P-ESWL. Patients aged over 65 years were included in the geriatric group; patients aged under 65 years who underwent P-ESWL in the same period were assigned to the control group. For investigation of long-term follow-up, the geriatric group were matched with patients from the control group in a 1:1 ratio. The primary outcomes were P-ESWL complications and pain relief. The secondary outcomes included: stone clearance, physical and mental health, quality of life score, and body weight.

Official Title
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Safety and Efficacy of Extracorporeal Shock Wave Lithotripsy for Geriatric Patients With Chronic Pancreatitis

Conditions
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Chronic Pancreatitis, Geriatric, Extracorporeal Shock Wave Lithotripsy

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with painful chronic pancreatitis and radiopaque stones of ≥5mm. Exclusion Criteria: Patients with a suspected or established malignant mass or pancreatic ascites, and pregnant patients.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| P-ESWL complications | The complications after P-ESWL. Including post-ESWL pancreatitis, bleeding, infection, steinstrasse, and perforation. The degree of these complications will also be measured. | April 30, 2016 | 
| Pain relief by the end of follow-up period | Participants will be followed up annually either by return visit or telephone call. Condition of abdominal pain or acute pancreatitis attack during follow-up will be measured. Pain relief at the end of the follow-up period was classified as complete relief (Izbicki pain score≤10) or partial relief (Izbicki pain score >10 after a decrease of >50%) | April 30, 2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stone clearance as assessed by ERCP performed post-ESWL | Stone clearance was evaluated at the ERCP performed post-ESWL, with complete clearance defined as clearance of >90% of the main pancreatic duct stone volume, whereas partial clearance was defined as clearance of 50%-90% of the stone volume. | April 30, 2016 | 
| Physical and mental health assessed by SF-36 questionnaire | Physical and mental health after treatment were assessed according to the scores on the SF-36 questionnaire. | April 30, 2018 | 
| Quality of life score assessed by the patient | Quality of life score after treatment were assessed by the patient and ranged from 0 to 100, with higher scores indicating a better quality of life. | April 30, 2018 | 
| Body weight | Body weight after treatment | April 30, 2018 |