Risk Factors for Post-ESWL and Post-ERCP Pancreatitis

Risk Factors for Post-ESWL and Post-ERCP Pancreatitis in Patients With Chronic Pancreatitis

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.

Study Overview

• Status: Completed
• Conditions: Chronic Pancreatitis; Risk Factors; ERCP; ESWL

• Study Type: Observational
• Enrollment (Actual): 714

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Consecutive CP patients treated with both ESWL and subsequent ERCP during the same hospitalization between October 2016 and July 2019 were included.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Changhai Hospital

Publications and helpful links

General Publications

• Ru N, Qian YY, Zhu JH, Chen H, Zou WB, Hu LH, Pan J, Guo JY, Li ZS, Liao Z. Post-ESWL and post-ERCP pancreatitis in patients with chronic pancreatitis: Do they share the same risks? J Hepatobiliary Pancreat Sci. 2021 Sep;28(9):778-787. doi: 10.1002/jhbp.1013. Epub 2021 Jul 22.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 31, 2016
• Primary Completion (ACTUAL): July 31, 2019
• Study Completion (ACTUAL): July 31, 2019

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 3, 2020
• First Posted (ACTUAL): November 6, 2020

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2020
• Last Update Submitted That Met QC Criteria: November 3, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: ESWL&ERCP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No