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

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ClinicalTrials.gov Identifier: NCT03373682
Recruitment Status : Active, not recruiting
First Posted : December 14, 2017
Last Update Posted : December 14, 2017
Sponsor:
Information provided by (Responsible Party):
Zhaoshen Li, 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.

Condition or disease
Chronic Pancreatitis Geriatric Extracorporeal Shock Wave Lithotripsy

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.

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Study Type : Observational
Actual Enrollment : 1404 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Safety and Efficacy of Extracorporeal Shock Wave Lithotripsy for Geriatric Patients With Chronic Pancreatitis
Actual Study Start Date : January 1, 2011
Actual Primary Completion Date : April 30, 2016
Estimated Study Completion Date : April 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis Shock




Primary Outcome Measures :
  1. 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.

  2. 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%)


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. Body weight [ Time Frame: April 30, 2018 ]
    Body weight after treatment



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Chronic pancreatitis patients with pancreatic stones in China
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373682


Locations
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China
Changhai Hospital, Second Military Medical University
Shanghai, China, 200433
Sponsors and Collaborators
Changhai Hospital

Publications:
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Responsible Party: Zhaoshen Li, Director of Gastroenterology Dept., Changhai Hospital
ClinicalTrials.gov Identifier: NCT03373682     History of Changes
Other Study ID Numbers: ESWL-01
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: December 14, 2017
Last Verified: December 2017
Additional relevant MeSH terms:
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Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases