Acute PancreatitisNCT01911689

Magnetic Resonance Imaging Study of Acute Pancreatitis

An observational study of Acute Pancreatitis, run by Afﬁliated Hospital of North Sichuan Medical College at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Acute Pancreatitis
How many people: 168 participants
Where: 1 siteChina
Study dates: Aug 2013to Mar 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

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.

Who may be able to join

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.

Who cannot join

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).

Trial locations and contacts

1 site in 1 country.

China1 site

Afﬁliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000

Other trials in China

About this study

Read the detailed description

We design a prospective study about "Magetic Resonance Imaging Study of Acute Pancreatitis".
We apply for an account and register our study on the clinicalTrials.
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 .
This calculation process for T2* value is completed using post-processing software on the workstation(Advantage workstation 4.4; GE Halthcare) directly after scanning.
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.
However, until now, there is no research on the sequence applied in the patients with AP.

Conditions: Acute Pancreatitis
Keywords: pancreatitis, MRI, APACHEⅡ, T2*, T2 star
Medical subject headings: Pancreatitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01911689
Study group	Role	What they receive
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).

What is being measured

The primary outcome is the main question the study is designed to answer.

The T2* Values in the Diagnosis of AP
Compare the difference of the T2* value between the AP group and the control group.
Measured: 1 year

Secondary outcomes (3)

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
Measured: 1 year
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 .
Measured: 1 year
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.
Measured: 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2013Mar 2015

First posted30 Jul 2013 (estimated)
Study startAug 2013
Primary completionMar 2015
Study completionMar 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Acute PancreatitisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 168 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01911689
Sponsor's protocol ID: SKLMC-2013-001
Status last verified: Nov 2014
First submitted: 26 Jul 2013
Last updated: 24 Aug 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Pancreatitis trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Magnetic Resonance Imaging Study of Acute Pancreatitis
ClinicalTrials.gov ID: NCT01911689
Acronym / sponsor ID: SKLMC-2013-001
Conditions: Acute Pancreatitis
Keywords: pancreatitis, MRI, APACHEⅡ, T2*, T2 star
Study type: Observational
Recruitment status: Completed
Enrolment: 168 participants (actual)
Lead sponsor: Afﬁliated Hospital of North Sichuan Medical CollegeUniversity, hospital or other
Study start: Aug 2013
Primary completion: Mar 2015 (actual)
Study completion: Mar 2015 (actual)
First posted: 30 Jul 2013 (estimated)
Results: Posted 24 Aug 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

We design a prospective study about "Magetic Resonance Imaging Study of Acute Pancreatitis".
We apply for an account and register our study on the clinicalTrials.
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 .
This calculation process for T2* value is completed using post-processing software on the workstation(Advantage workstation 4.4; GE Halthcare) directly after scanning.
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.
However, until now, there is no research on the sequence applied in the patients with AP.

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
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).

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult
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.

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (6 listed)

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 ;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

The T2* Values in the Diagnosis of AP
Time frame: 1 year
Compare the difference of the T2* value between the AP group and the control group.

3 secondary outcomes

The Difference of T2* Value Between the Edematous AP and Necrotizing AP
Time frame: 1 year
The T2* Value in Different Severity of AP According to MRSI
Time frame: 1 year
The Relationship Between the T2* Value and the Severity of AP According to Apache II
Time frame: 1 year

Results and safety

Results posted to the registry on 24 Aug 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Acute Pancreatitis	117	117
Controlgroup	51	51

Primary outcome: The T2* Values in the Diagnosis of AP

Time frame: 1 year. Mean (Standard Deviation). Unit: ms

Measure	Acute Pancreatitis n = 117	Control Group n = 51
Value	25.86 (4.90)	21.06 (2.64)

Acute Pancreatitis vs Control Group: p <0.01, t-test, 2 sided

Population analysed: compare T2\* value between the AP group and the control group using independent sample t test

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: 6 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Acute Pancreatitis	0 of 117 (0%)	0 of 117 (0%)	Not reported
Controlgroup	0 of 51 (0%)	0 of 51 (0%)	Not reported

Limitations and caveats (from the sponsor): Some diseases, such as chronic anemia, diabetes, etc., may lead to iron deposition in pancreas and may lead to change the T2\* value.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Acute Pancreatitis

Recruiting
Efferon LPS Hemoadsorption in Patients With Acute Pancreatitis
Pancreatitis, Acute
Recruiting
Timing of CHolecystectomy In Severe PAncreatitis
Acute Pancreatitis, Cholelithiasis
Not yet recruiting
Cold Water Papillary Irrigation Plus Rectal NSAIDs vs Rectal NSAIDs Alone for Post-ERCP Pancreatitis (COLD)
Post ERCP Pancreatitis, Acute Pancreatitis (AP)
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingPhase 1/2
Soy Tomato Juice to Improve Outcomes in Pancreatitis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

zhang x ming, PHD study chair

Afﬁliated Hospital of North Sichuan Medical College

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Acute Pancreatitis, run by Afﬁliated Hospital of North Sichuan Medical College at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Aug 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The T2* Values in the Diagnosis of AP (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01911689.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2015.