NCT01315613

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
44

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2005

Typical duration 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2008

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

March 11, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
Last Updated

March 15, 2011

Status Verified

September 1, 2008

Enrollment Period

3.7 years

First QC Date

March 11, 2011

Last Update Submit

March 14, 2011

Conditions

Acute Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Concentration of soluble ST2 in serum

    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.

    Within 30 days after onset of acute pancreatitis

Study Arms (1)

Acute pancreatitis

Patients admitted in our institution for an episode of acute pancreatitis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients of Erasme University Hospital

You may qualify if:

  • 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

You may not qualify if:

  • Chronic pancreatitis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasme Hospital

Brussels, 1070, Belgium

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System Diseases

Study Officials

  • Romy Ouziel, MD

    Erasme University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

March 11, 2011

First Posted

March 15, 2011

Study Start

January 1, 2005

Primary Completion

September 1, 2008

Study Completion

September 1, 2008

Last Updated

March 15, 2011

Record last verified: 2008-09

Locations

BE(1)