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

Post-ERCP Acute Pancreatitis Clinical Trial

Official title:

Changhai Hospital, the Second Military Medical University

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02781987
• Other study ID #: PEP-CP
• Secondary ID: 8147088481422010
• Status: Completed
• Phase: N/A
• First received: May 18, 2016
• Last updated: January 12, 2017
• Start date: January 2011
• Est. completion date: May 2015

Study information

• Verified date: January 2017
• Source: Changhai Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2028
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Pancreatitis
• Post-ERCP Acute Pancreatitis

Intervention

Other:
• chronic pancreatitis
patients with chronic pancreatitis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

References & Publications (1)

Zhao ZH, Hu LH, Ren HB, Zhao AJ, Qian YY, Sun XT, Su S, Zhu SG, Yu J, Zou WB, Guo XR, Wang L, Li ZS, Liao Z. Incidence and Risk Factors for post-ERCP Pancreatitis in Chronic Pancreatitis. Gastrointest Endosc. 2017 Jan 3. pii: S0016-5107(16)30897-5. doi: 1 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Numbers of biliary disease patients with post-ERCP pancreatitis, previous pancreatitis and previous PEP.		2 months