NCT03482921

Brief Summary

This study is to assess the predictive significance of visceral adipose tissue (VAT) and visceral adipose tissue /skeletal muscle tissue ratio (VAT/SMT ratio) for the prognosis in acute pancreatitis (AP) patients.

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 Dec 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 23, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 29, 2018

Completed
Last Updated

March 29, 2018

Status Verified

March 1, 2018

Enrollment Period

2 months

First QC Date

March 23, 2018

Last Update Submit

March 23, 2018

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (2)

  • Comparisons of variables according to AP severity

    Comparisons of variables according to AP severity by one-way analysis of variance (ANOVA) and Likelihood Ratio

    the physical examination data in the year of 2017

  • Relationships between VAT and severity outcomes Relationships between VAT and severity outcomes Relationships between VAT and severity outcomes Relationships between body parameters and severity outcomes

    Relationships between VAT and severity outcomes by Likelihood Ratio

    the physical examination data in the year of 2017

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (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:

  • age\<18years
  • missing data in the electronic medical record
  • history of AP

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ningbo NO.1 hospital

Ningbo, Zhejiang, 315010, China

Location

Related Publications (1)

  • Xie J, Xu L, Pan Y, Li P, Liu Y, Pan Y, Xu L. Impact of visceral adiposity on severity of acute pancreatitis: a propensity score-matched analysis. BMC Gastroenterol. 2019 Jun 13;19(1):87. doi: 10.1186/s12876-019-1015-z.

    PMID: 31195984DERIVED

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System 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
7 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2018

First Posted

March 29, 2018

Study Start

December 1, 2017

Primary Completion

February 12, 2018

Study Completion

March 22, 2018

Last Updated

March 29, 2018

Record last verified: 2018-03

Locations

CN(1)