NCT03373682

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,404

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
5.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2016

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 14, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
Last Updated

December 14, 2017

Status Verified

December 1, 2017

Enrollment Period

5.3 years

First QC Date

December 6, 2017

Last Update Submit

December 10, 2017

Conditions

Chronic PancreatitisGeriatricExtracorporeal Shock Wave Lithotripsy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Stone clearance as assessed by ERCP performed post-ESWL

    April 30, 2016

  • Physical and mental health assessed by SF-36 questionnaire

    April 30, 2018

  • Quality of life score assessed by the patient

    April 30, 2018

  • Body weight

    April 30, 2018

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Chronic pancreatitis patients with pancreatic stones in China

You may qualify if:

  • Patients with painful chronic pancreatitis and radiopaque stones of ≥5mm.

You may not qualify if:

  • Patients with a suspected or established malignant mass or pancreatic ascites, and pregnant patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital, Second Military Medical University

Shanghai, 200433, China

Location

Related Publications (4)

  • Wang D, Bi YW, Ji JT, Xin L, Pan J, Liao Z, Du TT, Lin JH, Zhang D, Zeng XP, Ye B, Zou WB, Chen H, Xie T, Li BR, Zheng ZH, Li ZS, Hu LH. Extracorporeal shock wave lithotripsy is safe and effective for pediatric patients with chronic pancreatitis. Endoscopy. 2017 May;49(5):447-455. doi: 10.1055/s-0043-104527. Epub 2017 Apr 12.

    PMID: 28403504BACKGROUND

  • Hu LH, Ye B, Yang YG, Ji JT, Zou WB, Du TT, Hao JF, Jiang YY, Liao Z, Li ZS. Extracorporeal Shock Wave Lithotripsy for Chinese Patients With Pancreatic Stones: A Prospective Study of 214 Cases. Pancreas. 2016 Feb;45(2):298-305. doi: 10.1097/MPA.0000000000000464.

    PMID: 26418906BACKGROUND

  • Li BR, Liao Z, Du TT, Ye B, Chen H, Ji JT, Zheng ZH, Hao JF, Ning SB, Wang D, Lin JH, Hu LH, Li ZS. Extracorporeal shock wave lithotripsy is a safe and effective treatment for pancreatic stones coexisting with pancreatic pseudocysts. Gastrointest Endosc. 2016 Jul;84(1):69-78. doi: 10.1016/j.gie.2015.10.026. Epub 2015 Nov 2.

    PMID: 26542375BACKGROUND

  • Li BR, Liao Z, Du TT, Ye B, Zou WB, Chen H, Ji JT, Zheng ZH, Hao JF, Jiang YY, Hu LH, Li ZS. Risk factors for complications of pancreatic extracorporeal shock wave lithotripsy. Endoscopy. 2014 Dec;46(12):1092-100. doi: 10.1055/s-0034-1377753. Epub 2014 Sep 24.

    PMID: 25251205BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of Gastroenterology Dept.

Study Record Dates

First Submitted

December 6, 2017

First Posted

December 14, 2017

Study Start

January 1, 2011

Primary Completion

April 30, 2016

Study Completion

April 30, 2018

Last Updated

December 14, 2017

Record last verified: 2017-12

Locations

CN(1)