NCT01911689

Brief Summary

To quantitatively analyze the T2\* values of the head, body, and tail of normal pancreas, and observe the value of GRE T2\*-weighted MRI in the diagnosis of acute pancreatitis and the relationship between the T2\* value and the severity of AP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
168

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

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

First Submitted

Initial submission to the registry

July 26, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
2 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
6 months until next milestone

Results Posted

Study results publicly available

August 24, 2015

Completed
Last Updated

August 24, 2015

Status Verified

November 1, 2014

Enrollment Period

1.6 years

First QC Date

July 26, 2013

Results QC Date

March 30, 2015

Last Update Submit

August 19, 2015

Conditions

Keywords

pancreatitisMRIAPACHEⅡT2*T2 star

Outcome Measures

Primary Outcomes (1)

  • The T2* Values in the Diagnosis of AP

    Compare the difference of the T2\* value between the AP group and the control group.

    1 year

Secondary Outcomes (3)

  • The Difference of T2* Value Between the Edematous AP and Necrotizing AP

    1 year

  • The T2* Value in Different Severity of AP According to MRSI

    1 year

  • The Relationship Between the T2* Value and the Severity of AP According to Apache II

    1 year

Study Arms (2)

acute pancreatitis

acute pancreatitis group:(a) acute onset of abdominal pain; (b) pancreatitis at first onset; (c) three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and (5) abdominal MR examination.

controlgroup

normal control group:without pancreatic disorders.The exclusion criteria in this study were as follows: (a) inability to cooperate when MR imaging was performed; (b) a history of chronic pancreatitis; (c) AP due to pancreatic carcinoma; (d) hypoproteinemia; and (e) with hypoproteinemia and other peritoneal/ retroperitoneal infection diseases ;(f) with iron deposition disorder (e.g. diabetes or blood system diseases).

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with AP admitted to our institution between August 2013 and March 2015 were considered for inclusion in this study. The inclusion criteria for patients in this study were as follows: (a) acute onset of abdominal pain; (b) pancreatitis at first onset; (c) three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and (d) abdominal MR examination.

You may qualify if:

  • acute onset of abdominal pain;
  • pancreatitis at first onset;
  • three-fold elevated amylase or lipase, excluding other causes of elevated enzymes; and
  • abdominal MR examination.

You may not qualify if:

  • inability to cooperate when MR imaging was performed;
  • a history of chronic pancreatitis;
  • AP due to pancreatic carcinoma;
  • hypoproteinemia;
  • with hypoproteinemia and other peritoneal/ retroperitoneal infection diseases ;
  • with iron deposition disorder (e.g. diabetes or blood system diseases).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of North Sichuan Medical College

Nanchong, Sichuan, 637000, China

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Limitations and Caveats

Some diseases, such as chronic anemia, diabetes, etc., may lead to iron deposition in pancreas and may lead to change the T2\* value.

Results Point of Contact

Title
Dr.XiaoMing Zhang
Organization
Sichuan Key Laboratory of Medical Imaging, Department of Radiology, Affiliated Hospital of North Sichuan Medical College

Study Officials

  • zhang x ming, PHD

    Affiliated Hospital of North Sichuan Medical College

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2013

First Posted

July 30, 2013

Study Start

August 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

August 24, 2015

Results First Posted

August 24, 2015

Record last verified: 2014-11

Locations