Safety and Efficacy of ESWL for Geriatric Patients With Chronic Pancreatitis

• Conditions: Geriatric; Chronic Pancreatitis; Extracorporeal Shock Wave Lithotripsy

• Registration Number: NCT03373682
• Lead Sponsor: Changhai Hospital

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.

Study Timeline

• Study Start: 2011-01-01
• Primary Completion: 2016-04-30
• Status Verified: 2017-12
• Study First Submitted: 2017-12-06
• Study First Submitted QC: 2017-12-10
• Last Update Submitted: 2017-12-10
• Study First Posted: 2017-12-14
• Last Update Posted: 2017-12-14
• Study Completion: 2018-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1404

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Body weight	April 30, 2018	Body weight after treatment
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.
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.
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.

Trial Locations

Locations (1)

Changhai Hospital, Second Military Medical University; 🇨🇳 Shanghai, China