Safety and Efficacy of ESWL for Geriatric Patients With Chronic Pancreatitis (ESWL)

December 10, 2017 updated by: Zhaoshen Li, Changhai Hospital

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

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Actual)

1404

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200433
        • Changhai Hospital, Second Military Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Chronic pancreatitis patients with pancreatic stones in China

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
P-ESWL complications
Time Frame: 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.
April 30, 2016
Pain relief by the end of follow-up period
Time Frame: 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%)
April 30, 2018

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stone clearance as assessed by ERCP performed post-ESWL
Time Frame: 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.
April 30, 2016
Physical and mental health assessed by SF-36 questionnaire
Time Frame: April 30, 2018
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
Time Frame: 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.
April 30, 2018
Body weight
Time Frame: April 30, 2018
Body weight after treatment
April 30, 2018

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2011

Primary Completion (Actual)

April 30, 2016

Study Completion (Anticipated)

April 30, 2018

Study Registration Dates

First Submitted

December 6, 2017

First Submitted That Met QC Criteria

December 10, 2017

First Posted (Actual)

December 14, 2017

Study Record Updates

Last Update Posted (Actual)

December 14, 2017

Last Update Submitted That Met QC Criteria

December 10, 2017

Last Verified

December 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESWL-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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