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

January 12, 2017 updated by: Zhuan Liao, Changhai Hospital

Changhai Hospital, the Second Military Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

2028

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 85 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Chronic pancreatitis patients underwent ERCP from January 2011 to May 2015 in Changhai Hospital.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
CP group
Those patients with chronic pancreatitis underwent ERCP for pancreatic stone clearance, pancreatic stent placement, etc..
Other: chronic pancreatitis
patients with chronic pancreatitis
BD group
Those patients with biliary ductal disease, such as choledocholithiasis, underwent ERCP to relieve outflow obstruction of the common bile duct.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: 8 months
8 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Numbers of biliary disease patients with post-ERCP pancreatitis, previous pancreatitis and previous PEP.
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changhai Hospital

Investigators

  • Study Chair: Zhao-shen Li, Changhai Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

May 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

May 18, 2016

First Submitted That Met QC Criteria

May 20, 2016

First Posted (ESTIMATE)

May 25, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 12, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEP-CP
  • 81470884 (OTHER_GRANT: National Natural Science Foundation of China)
  • 81422010 (OTHER_GRANT: National Natural Science Foundation of China)
  • 81270541 (OTHER_GRANT: National Natural Science Foundation of China)
  • 13QA1404600 (OTHER_GRANT: the Shanghai Rising-Star Program)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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