Chronic Pancreatitis, Extracorporeal Shock Wave Lithotripsy, Geriatric
Conditions
Brief summary
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
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.
Interventions
None listed
Sponsors
Changhai Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| P-ESWL complications | April 30, 2016 | The complications after P-ESWL. Including post-ESWL pancreatitis, bleeding, infection, steinstrasse, and perforation. The degree of these complications will also be measured. |
| Pain relief by the end of follow-up period | April 30, 2018 | 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%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stone clearance as assessed by ERCP performed post-ESWL | April 30, 2016 | 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. |
| Physical and mental health assessed by SF-36 questionnaire | April 30, 2018 | Physical and mental health after treatment were assessed according to the scores on the SF-36 questionnaire. |
| Quality of life score assessed by the patient | April 30, 2018 | 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. |
| Body weight | April 30, 2018 | Body weight after treatment |
Countries
China
Outcome results
None listed