Chronic Pancreatitis Clinical Trial
Official title:
Risk Factors for Post-ESWL and Post-ERCP Pancreatitis in Patients With Chronic Pancreatitis
NCT number | NCT04619511 |
Other study ID # | ESWL&ERCP |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 31, 2016 |
Est. completion date | July 31, 2019 |
Verified date | November 2020 |
Source | Changhai Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The study aimed to identify risk factors for post-ERCP pancreatitis(PEP) after ESWL, and the relationship between the occurrence of post-ESWL pancreatitis and PEP.
Status | Completed |
Enrollment | 714 |
Est. completion date | July 31, 2019 |
Est. primary completion date | July 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | Inclusion Criteria: - Patients diagnosed with chronic pancreatitis and treated with both ESWL and subsequent ERCP Exclusion Criteria: - Patients with isolated pancreatic tail stone - Patients with suspected or established malignancy - Patients with pancreatic ascites - Patients attending other interventional clinical trials - Patients with non-correctable coagulation disorder - Patients with pregnancy |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Changhai Hospital |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | post endoscopic retrograde cholangiopancreatography(ERCP) pancreatitis | The main outcome analyzed was the development of post-procedural pancreatitis, which was defined as clinical pancreatitis, meeting two of three the following criteria in accordance with the Revised Atlanta International consensus including pain consistent with AP; amylase or lipase more than 3 times the upper normal limit; characteristic findings on imaging. | up to 1 months | |
Primary | post pancreatic extracorporeal shock wave lithotripsy (ESWL) pancreatitis | The main outcome analyzed was the development of post-procedural pancreatitis, which was defined as clinical pancreatitis, meeting two of three the following criteria in accordance with the Revised Atlanta International consensus including pain consistent with AP; amylase or lipase more than 3 times the upper normal limit; characteristic findings on imaging. | up to 1 months |
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