Magnetic Resonance Imaging Study of Acute Pancreatitis

Acute Pancreatitis Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01911689
• Other study ID #: SKLMC-2013-001
• Status: Completed
• Phase: N/A
• First received: July 26, 2013
• Last updated: August 19, 2015
• Start date: August 2013
• Est. completion date: March 2015

Study information

• Verified date: November 2014
• Source: Af?liated Hospital of North Sichuan Medical College
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

1. We design a prospective study about "Magetic Resonance Imaging Study of Acute Pancreatitis".

2. We apply for an account and register our study on the clinicalTrials.

3. In patients with acute pancreatitis, imaging is recommended to confirm the clinical diagnosis, investigate the etiology, and grade the severity of the disease . MR had the excellent resolution of soft tissue，and it has earned an ever more important role in the diagnosis of AP. With the continuous development of MR scanning techniques, the sequence of a multi-echo gradient recalled echo (GRE) T2*-weighted imaging (T2*WI), which acquires a spin echo signal, T2* relaxation acquires a gradient echo signal, is a relatively new MRI technique. The sequence of a GRE T2*WI requires high uniformity of the magnetic field, plus it can provide the T2* value, which can indirectly reflect changes in tissue biochemical components, thus it can be used for the early diagnosis quantitative diagnosis of some diseases .

4. This calculation process for T2* value is completed using post-processing software on the workstation(Advantage workstation 4.4; GE Halthcare) directly after scanning.

5. AP is a process of inflammation diffusion, in which cell edema will lead to hydrogen proton increase. In the inflammatory exudation process, T2* value will change. So we conduct our research. In this study, we will observe pancreas in the normal pancreas and AP, and discuss the relationship between T2* value and that of AP graded by the MR severity index (MRSI) and Acute Physiology And Chronic Healthy Evaluation II (APACHE II) scores.

6. However, until now, there is no research on the sequence applied in the patients with AP.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 168
• Est. completion date: March 2015
• Est. primary completion date: March 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Pancreatitis
• Pancreatitis

Locations

Country	Name	City	State
China	Af?liated Hospital of North Sichuan Medical College	NanChong	Sichuan

Sponsors (1)

Lead Sponsor	Collaborator
Af?liated Hospital of North Sichuan Medical College

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	The Difference of T2* Value Between the Edematous AP and Necrotizing AP	Compare the difference of the T2* value between the edematous AP group and necrotizing AP group	1 year	No
Secondary	The T2* Value in Different Severity of AP According to MRSI	AP was graded as mild (0-3 points), moderate (4-6 points) or severe (7-10 points), according to the MR-severity index (MRSI) which was derived from the CT-severity index .	1 year	No
Secondary	The Relationship Between the T2* Value and the Severity of AP According to Apache II	In clinical practice, the physician usually used the APACHE II to evaluate the severity of acute pancreatitis. AP was graded as mild (0-7 points) and severe AP (=8 points) according to the APACHE II scoring system.	1 year	Yes