Incidence and Risk Factor of Post-ERCP Pancreatitis in Chronic Pancreatitis

Completed

• Conditions: Post-ERCP Acute Pancreatitis
• Interventions: Other: chronic pancreatitis

• Registration Number: NCT02781987
• Lead Sponsor: Changhai Hospital

Brief Summary

The purpose of this study is to compare the incidence of post-ERCP pancreatitis (PEP) in chronic pancreatitis (CP) patients to that in biliary disease patients, to determine whether CP patients in early clinical stage have a higher PEP incidence, and to identify the predictive and protective factors for PEP in chronic pancreatitis patients.

Detailed Description

Analysis of patients with chronic pancreatitis (CP group) and biliary disease (BD group) in Changhai Hospital from January 2011 to May 2015 were conducted. Difference of PEP incidences between BD group and CP group, as well as between M-ANNHEIM subcategories were calculated by chi-square test or Fisher's exact test. The predictive and protective factors for PEP were investigated by univariate and multivariate analysis.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-20
• Study First Posted: 2016-05-25
• Status Verified: 2017-01
• Last Update Submitted: 2017-01-12
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2028

Inclusion Criteria

• patients with an endoscope inserted to cannulate the pancreatic/biliary duct were included.

Exclusion Criteria

• patients in whom the papilla of Vater was not reached;
• patients who underwent stent removal procedures without ductal cannulation;
• patients in whom the intubation was failed.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CP group	chronic pancreatitis	Those patients with chronic pancreatitis underwent ERCP for pancreatic stone clearance, pancreatic stent placement, etc..

Primary Outcome Measures

Name	Time	Method
Numbers of chronic pancreatitis patients with post-ERCP pancreatitis, diabetes mellitus, steatorrhea, previous pancreatitis, previous PEP, pancreatic divisum, jaundice, ESWL, pancreatic duct stone, drainage and minor papilla pancreatogram.	8 months

Secondary Outcome Measures

Name	Time	Method
Numbers of biliary disease patients with post-ERCP pancreatitis, previous pancreatitis and previous PEP.	2 months