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Status unknownNCT03830060Updated Feb 5, 2019

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

An observational study in Acute Pancreatitis, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2019-02-05.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Feb 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 60 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Acute Pancreatitis

Keywords

  • Marker of inflammation
  • high-sensitivity CRP
  • Antinuclear antibodies
  • Cortisol
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In context

Pancreatitis

752 studies on the registry are indexed under Pancreatitis; 181 are open to participants now.

This study's planned enrollment of 50 is below the median of 180 across 277 observational studies indexed under Pancreatitis.

Browse Pancreatitis studies →

Lead sponsor

Assiut University is the lead sponsor of 4,901 studies on the registry; 2,098 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Acute pancreatitis

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

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • Group I:

    Fifty AP patients on admission

    Diagnostic Test: Measurement of cortisol

  • Group II:

    The previous AP patients after 72 hours

    Diagnostic Test: Measurement of cortisol

Interventions

  • Diagnostic testMeasurement of cortisol

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

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What researchers measure

Primary outcomes

  1. The mean difference of cortisol before and after treatment

    Cortisol mean difference will be measured by immunofluorescence in acute pancreatitis.

    Time frame: 72 hours

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 17625291 ↗
  • 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. PubMed 12483249 ↗
  • 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. PubMed 29215538 ↗
  • 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. PubMed 22844291 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 5, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03830060
Lead sponsor
Assiut University
Responsible party
Reham I El-mahdy (Principal Investigator, Assiut University) — Principal investigator
First posted
Feb 5, 2019
Start date
Feb 25, 2019 (estimated)
Primary completion
May 20, 2019 (estimated)
Completion
May 30, 2019 (estimated)
Last update
Feb 5, 2019

Study contacts

reham elmahdy
Contact
reham.elmahdy@aun.edu.eg
+201002714637

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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