Role of ST2 in Acute Pancreatitis

This study has been completed.

Sponsor:

Information provided by:

Erasme University Hospital

ClinicalTrials.gov Identifier:

NCT01315613

First received: March 11, 2011

Last updated: March 14, 2011

Last verified: September 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

March 11, 2011

Last Updated Date

March 14, 2011

Start Date ^ICMJE

January 2005

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Concentration of soluble ST2 in serum [ Time Frame: Within 30 days after onset of acute pancreatitis ] [ Designated as safety issue: No ]

Concentration of soluble ST2 will be assessed in the serum of patient with an episode of acute pancreatitis, on the day of admission to the hospital as well as 24h, 48h, 7 days and 30 days later.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01315613 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Role of ST2 in Acute Pancreatitis

Official Title ^ICMJE

Study of ST2-IL-33 Pathway in Acute Pancreatitis

Brief Summary

Acute pancreatitis is characterized by an inflammatory storm which regulatory pathways are not well known. The IL-1 cytokine family is activated early during acute pancreatitis and secretion of alarmins is speculated during pancreatic necrosis. IL-33 is a member of the IL-1 family, it can act as an alarmin and its receptor, ST2, is known to sequester MyD88 which might regulate the acute pancreatitis inflammatory storm. The aim of this study is to investigate ST2 pathway in human acute pancreatitis and in murine experimental models of acute pancreatitis.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case Control
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

Patients of Erasme University Hospital

Condition ^ICMJE

Acute Pancreatitis

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Acute pancreatitis

Patients admitted in our institution for an episode of acute pancreatitis

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2008

Primary Completion Date

September 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Time to take blood sample less than 24h after the onset of symptoms of AP
Two of the following: typical pain, amylase and lipase concentrations more than 3x the upper normal limit, compatible modifications on imaging techniques

Exclusion Criteria:

Chronic pancreatitis

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Belgium

Administrative Information

NCT Number ^ICMJE

NCT01315613

Other Study ID Numbers ^ICMJE

RO-ST2

Has Data Monitoring Committee

Not Provided

Responsible Party

Romy Ouziel,, Erasme Hospital

Study Sponsor ^ICMJE

Erasme University Hospital

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Romy Ouziel, MD

Erasme Hospital

Information Provided By

Erasme University Hospital

Verification Date

September 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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