Risk Factors for Post-ESWL and Post-ERCP Pancreatitis

Chronic Pancreatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04619511
• Other study ID #: ESWL&ERCP
• Status: Completed
• Start date: October 31, 2016
• Est. completion date: July 31, 2019

Study information

• Verified date: November 2020
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Chronic Pancreatitis
• ERCP
• ESWL
• Pancreatitis
• Pancreatitis, Chronic
• Risk Factors

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Outcome

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