Trial record 19 of 399 for:    pancreatitis

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Zhuan Liao, Changhai Hospital
ClinicalTrials.gov Identifier:
NCT02781987
First received: May 18, 2016
Last updated: May 20, 2016
Last verified: May 2016
  Purpose
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.

Condition Intervention
Post-ERCP Acute Pancreatitis
Other: chronic pancreatitis

Study Type: Observational
Study Design: Observational Model: Case Control
Official Title: Changhai Hospital, the Second Military Medical University

Resource links provided by NLM:


Further study details as provided by Changhai Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Numbers of biliary disease patients with post-ERCP pancreatitis, previous pancreatitis and previous PEP. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]

Enrollment: 2028
Study Start Date: January 2011
Study Completion Date: May 2015
Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Ages Eligible for Study:   5 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Chronic pancreatitis patients underwent ERCP from January 2011 to May 2015 in Changhai Hospital.
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02781987

Sponsors and Collaborators
Changhai Hospital
Investigators
Study Chair: Zhao-shen Li Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
  More Information

Responsible Party: Zhuan Liao, associate professor, Changhai Hospital
ClinicalTrials.gov Identifier: NCT02781987     History of Changes
Other Study ID Numbers: PEP-CP  81470884  81422010  81270541  13QA1404600 
Study First Received: May 18, 2016
Last Updated: May 20, 2016
Health Authority: China: National Natural Science Foundation

Additional relevant MeSH terms:
Pancreatitis
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on May 26, 2016