Clinical Usefulness of Cortisol, Antinuclear Antibodies and High-sensitivity C-reactive Protein in Acute Pancreatitis

NCT ID: NCT03830060

Last Updated: 2019-02-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-02-25
• Study Completion Date: 2019-05-30

Brief Summary

Acute pancreatitis (AP) is a potentially life-threatening disease with varying severity of presentation. Nearly 60%-80% of all cases of AP in developed countries are attributable to either gallstone disease or alcohol abuse. The incidence is similar in both sexes, although alcohol abuse is the more common cause in men and gallstones is the more common cause in women.

Detailed Description

Severe acute pancreatitis is one of the most common acute abdomens in clinical practice. Owing to its acute onset, rapid progress, and high mortality, it has become a hot clinical study spot and one of the toughest medical problems. Markers of inflammation, such as high-sensitivity CRP (hs-CRP), are predictive of the severity of acute pancreatitis and may be useful in identifying patients with severe acute pancreatitis in the early phase after onset.

Antinuclear antibodies (ANA) are important biomarkers for the autoimmune disorder. ANA may contribute to the pathogenesis of pancreatitis and ANA positivity is associated with the presence of autoimmune pancreatitis. Cortisol is released into the blood due to stimulation of corticotrophin receptors in the adrenal cortex. Thus, serum cortisol can be measured. Although the association between serum levels of some inflammatory marker and acute pancreatitis revealed, the relationship between ANA, cortisol, hs-CRP and with the severity of acute pancreatic lesions have not evaluated yet.

Conditions

Acute Pancreatitis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Group I:

Fifty AP patients on admission

Measurement of cortisol

Intervention Type: DIAGNOSTIC_TEST

Cortisol will be measured by immunofluorescence and correlated with ANA and hs-CRP

Group II:

The previous AP patients after 72 hours

Measurement of cortisol

Intervention Type: DIAGNOSTIC_TEST

Cortisol will be measured by immunofluorescence and correlated with ANA and hs-CRP

Interventions

Measurement of cortisol

Cortisol will be measured by immunofluorescence and correlated with ANA and hs-CRP

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• abdominal pain consistent with AP
• serum amylase activity at least 3 times greater than the upper limit of normal
• Patients of age 18 years or more who are willing to participate in the study and give their consent for same.

Exclusion Criteria

• Patients with severe liver disease, pulmonary embolus, sepsis, and renal failure were excluded from the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Reham I El-mahdy

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

reham elmahdy

Role: CONTACT

reham.elmahdy@aun.edu.eg

+201002714637

References

Zhang XP, Zhang L, Wang Y, Cheng QH, Wang JM, Cai W, Shen HP, Cai J. Study of the protective effects of dexamethasone on multiple organ injury in rats with severe acute pancreatitis. JOP. 2007 Jul 9;8(4):400-12.

Reference Type: BACKGROUND

PMID: 17625291 (View on PubMed)

Imamura T, Tanaka S, Yoshida H, Kitamura K, Ikegami A, Takahashi A, Niikawa J, Mitamura K. Significance of measurement of high-sensitivity C-reactive protein in acute pancreatitis. J Gastroenterol. 2002;37(11):935-8. doi: 10.1007/s005350200157.

Reference Type: BACKGROUND

PMID: 12483249 (View on PubMed)

Nebiker CA, Staubli S, Schafer J, Bingisser R, Christ-Crain M, Dell-Kuster S, Mueller C, Scamardi K, Viehl CT, Kolleth D, von Holzen U, Oertli D, Rosenthal R. Cortisol Outperforms Novel Cardiovascular, Inflammatory, and Neurohumoral Biomarkers in the Prediction of Outcome in Acute Pancreatitis. Pancreas. 2018 Jan;47(1):55-64. doi: 10.1097/MPA.0000000000000962.

Reference Type: BACKGROUND

PMID: 29215538 (View on PubMed)

Smyk DS, Rigopoulou EI, Koutsoumpas AL, Kriese S, Burroughs AK, Bogdanos DP. Autoantibodies in autoimmune pancreatitis. Int J Rheumatol. 2012;2012:940831. doi: 10.1155/2012/940831. Epub 2012 Jul 12.

Reference Type: BACKGROUND

PMID: 22844291 (View on PubMed)

Other Identifiers

Pancreatitis

Identifier Type: -

Identifier Source: org_study_id