NCT03566173

Brief Summary

The early evaluation of AP severity are vital. Previous studies have shown non-alcoholic fatty liver disease (NAFLD) is associated with severity of acute pancreatitis (AP). This study is aimed to investigate the relationship between NAFLD and AP severity.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,662

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

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

March 10, 2018

Completed
22 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 25, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 25, 2018

Completed
Last Updated

May 1, 2019

Status Verified

April 1, 2019

Enrollment Period

22 days

First QC Date

May 25, 2018

Last Update Submit

April 28, 2019

Conditions

Acute PancreatitisNonalcoholic Fatty Liver Disease

Outcome Measures

Primary Outcomes (1)

  • Comparisons of variables (age in years, BMI in kg/m2, pancreas attenuation in HU) on the basis of AP severity

    Comparisons of variables on the basis of AP severity by one-way analysis of variance (ANOVA)

    the physical examination data in the year of 2017

Secondary Outcomes (1)

  • Association between NAFLD and severity outcomes in AP patients

    the physical examination data in the year of 2017

Eligibility Criteria

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

Diagnosis criteria for AP was defined as the presence of at least 2 of the 3 following factors: (1) abdominal pain characteristic of AP; (2) serum amylase and/or lipase levels≥3 times the upper limit of the normal level, and (3) characteristic findings of AP on a CT scanning.

You may qualify if:

  • diagnosed with AP
  • age \>18 years

You may not qualify if:

  • an age of \<18 years
  • without complete data and CT scans
  • previous splenectomy or hepatectomy
  • a past history of AP
  • an ambiguous pancreatic margin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ningbo NO.1 hospital

Ningbo, Zhejiang, 315010, China

Location

MeSH Terms

Conditions

PancreatitisNon-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesFatty LiverLiver Diseases

Study Officials

  • Lei Xu, Dr

    Department of gastroenterology,Ningbo No.1 Hospital, Ningbo, China

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2018

First Posted

June 25, 2018

Study Start

March 10, 2018

Primary Completion

April 1, 2018

Study Completion

April 15, 2018

Last Updated

May 1, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)