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

NCT ID: NCT02781987

Last Updated: 2017-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

2028 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-01-31

Study Completion Date

2015-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Post-ERCP Acute Pancreatitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CP group

Those patients with chronic pancreatitis underwent ERCP for pancreatic stone clearance, pancreatic stent placement, etc..

chronic pancreatitis

Intervention Type OTHER

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.

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

chronic pancreatitis

patients with chronic pancreatitis

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

5 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhuan Liao

associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Zhao-shen Li

Role: STUDY_CHAIR

Changhai Hospital

References

Explore related publications, articles, or registry entries linked to this study.

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 Sep;86(3):519-524.e1. doi: 10.1016/j.gie.2016.12.020. Epub 2017 Jan 4.

Reference Type RESULT
PMID: 28062312 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

81470884

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

81422010

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

81270541

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

13QA1404600

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PEP-CP

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.