Role of ST2 in Acute Pancreatitis | NCT01315613

Studies
Role of ST2 in Acute Pancreatitis

NCT01315613

Sponsor

Erasme University Hospital

Status

Completed

Last Update Posted

Mar 15, 2011Estimated

Enrollment

44Actual

Phase

Not provided

Conditions

Acute Pancreatitis

Interventions

Not provided

Countries

Belgium

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2008

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2005

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2008

First Submitted Date

Mar 11, 2011

First Submission Date that Met QC Criteria

Mar 14, 2011

First Posted Date

Mar 15, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2011

Last Update Posted Date

Mar 15, 2011Estimated

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

44Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Acute pancreatitis		Patients admitted in our institution for an episode of acute pancreatitis

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients of Erasme University Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Romy Ouziel, MD	Erasme University Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Erasme Hospital		Brussels		1070	Belgium

Condition Browse Module

MeSH Terms

ID	Term
D010195	Pancreatitis

Ancestor Terms

ID	Term
D010182	Pancreatic Diseases
D004066	Digestive System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided