Chronic PancreatitisESWLNCT03373682
Safety and Efficacy of ESWL for Geriatric Patients With Chronic Pancreatitis
An observational study of Chronic Pancreatitis and Geriatric, run by Changhai Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Pancreatitis, Geriatric, Extracorporeal Shock Wave Lithotripsy
- How many people
- 1,404 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2011to 30 Apr 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Chronic pancreatitis patients with pancreatic stones in China
Who may be able to join
- Patients with painful chronic pancreatitis and radiopaque stones of ≥5mm.
Who cannot join
- Patients with a suspected or established malignant mass or pancreatic ascites, and pregnant patients.
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital, Second Military Medical University
Shanghai, 200433
About this study
Official title: 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.
Read the 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.
- Medical subject headings
- Pancreatitis, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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%)
Measured: April 30, 2018
Secondary outcomes (4)
Stone clearance as assessed by ERCP performed post-ESWL
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.
Measured: April 30, 2016
Physical and mental health assessed by SF-36 questionnaire
Physical and mental health after treatment were assessed according to the scores on the SF-36 questionnaire.
Measured: April 30, 2018
Quality of life score assessed by the patient
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.
Measured: April 30, 2018
Body weight
Body weight after treatment
Measured: April 30, 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2017
- Study start1 Jan 2011
- Primary completion30 Apr 2016
- Study completion30 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,404 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhaoshen Li, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03373682
- Sponsor's protocol ID
- ESWL-01
- Acronym
- ESWL
- Status last verified
- Dec 2017
- First submitted
- 6 Dec 2017
- Last updated
- 14 Dec 2017
- Results posted
- No
Publications
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.
PubMed 28403504Hu 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.
PubMed 26418906Li 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.
PubMed 26542375Li 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.
PubMed 25251205
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Extracorporeal Shock Wave Lithotripsy for Geriatric Patients With Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT03373682
- Acronym / sponsor ID
- ESWL / ESWL-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,404 participants (actual)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Jan 2011 (actual)
- Primary completion
- 30 Apr 2016 (actual)
- Study completion
- 30 Apr 2018 (estimated)
- First posted
- 14 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Chronic pancreatitis patients with pancreatic stones in China
Key inclusion criteria (1 listed)
- Patients with painful chronic pancreatitis and radiopaque stones of ≥5mm.
Key exclusion criteria (1 listed)
- Patients with a suspected or established malignant mass or pancreatic ascites, and pregnant patients.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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%)
4 secondary outcomes
Stone clearance as assessed by ERCP performed post-ESWL
Time frame: April 30, 2016
Physical and mental health assessed by SF-36 questionnaire
Time frame: April 30, 2018
Quality of life score assessed by the patient
Time frame: April 30, 2018
Body weight
Time frame: April 30, 2018
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2017.
- Background: PubMed 28403504Wang 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.
- Background: PubMed 26418906Hu 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.
- Background: PubMed 26542375Li 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.
- Background: PubMed 25251205Li 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Pancreatitis and Geriatric, run by Changhai Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
P-ESWL complications (time frame: April 30, 2016). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03373682, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2017.