NCT03634787

Brief Summary

To investigate the role of Heat Shock Proteins in the mechanism of acute severe pancreatitis. In addition to test the potential treatment target of acute pancreatitis. All patients who present with clinical symptoms of acute pancreatitis are evaluated for the enrollment of the study.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 20, 2017

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 3, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2018

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2021

Completed
Last Updated

August 16, 2018

Status Verified

August 1, 2018

Enrollment Period

4.1 years

First QC Date

July 3, 2018

Last Update Submit

August 15, 2018

Conditions

Acute Pancreatitis

Keywords

Heat Shock Proteins, early diagnosis

Outcome Measures

Primary Outcomes (1)

  • To measure the levels of heat shock proteins in serum and plasma in acute severe pancreatitis settings

    Different molecular weight Heat Shock proteins role while developing acute pancreatitis.

    2 years

Secondary Outcomes (1)

  • To measure pancreas cells activity while applying Heat Shock Protein inhibitors

    2 years

Study Arms (2)

Acute pancreatitis

First time acute pancreatitis. No later than 2 days since the clinical symptoms started.

Diagnostic Test: CT Scan Day 5-7

Healthy

No major systemic illness

Interventions

CT Scan Day 5-7DIAGNOSTIC_TEST

Computed Tomography on Day 5-7 according to a clinical protocol.

Acute pancreatitis

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients admitted to the hospital within 48 hours since the typical symptoms of acute pancreatitis

You may qualify if:

  • no prior diagnosis of acute pancreatitis
  • admission to the hospital within 2 days since the clinical symptoms
  • confirmed diagnosis of acute pancreatitis

You may not qualify if:

  • chronic pancreatitis
  • pancreatic cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vilnius University Hospital "Santaros Klinikos

Vilnius, 08410, Lithuania

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine samples on admission

MeSH Terms

Conditions

PancreatitisDisease

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Kestutis Strupas, Prof. MD/PhD

CONTACT

+37052365000kestutis.strupas@santa.lt

Aiste Gulla, MD

CONTACT

+37052365000aiste.kielaite-gulla@santa.lt

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior surgery resident

Study Record Dates

First Submitted

July 3, 2018

First Posted

August 16, 2018

Study Start

October 20, 2017

Primary Completion

December 1, 2021

Study Completion

December 30, 2021

Last Updated

August 16, 2018

Record last verified: 2018-08

Locations

LI(1)