NCT02781987

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,028

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 25, 2016

Completed
Last Updated

January 13, 2017

Status Verified

January 1, 2017

Enrollment Period

4.3 years

First QC Date

May 18, 2016

Last Update Submit

January 12, 2017

Conditions

Post-ERCP Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Numbers of biliary disease patients with post-ERCP pancreatitis, previous pancreatitis and previous PEP.

    2 months

Study Arms (2)

CP group

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

Other: chronic pancreatitis

BD group

Those patients with biliary ductal disease, such as choledocholithiasis, underwent ERCP to relieve outflow obstruction of the common bile duct.

Interventions

chronic pancreatitisOTHER

patients with chronic pancreatitis

CP group

Eligibility Criteria

Age5 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

    PMID: 28062312RESULT

Study Officials

  • Zhao-shen Li

    Changhai Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 25, 2016

Study Start

January 1, 2011

Primary Completion

May 1, 2015

Study Completion

May 1, 2015

Last Updated

January 13, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share