A Multicenter, International Cohort Analysis of 1435 Cases to Support Clinical Trial Design in Acute Pancreatitis

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Hungarian Pancreatic Study Grp , Farkas , N , Hanak , L , Miko , A , Sallinen , V & Hegyi , P 2019 , ' A Multicenter, International Cohort Analysis of 1435 Cases to Support Clinical Trial Design in Acute Pancreatitis ' , Frontiers in Physiology , vol. 10 , 1092 . https://doi.org/10.3389/fphys.2019.01092

Title: A Multicenter, International Cohort Analysis of 1435 Cases to Support Clinical Trial Design in Acute Pancreatitis
Author: Hungarian Pancreatic Study Grp; Farkas, Nelli; Hanak, Lilla; Miko, Alexandra; Sallinen, Ville; Hegyi, Peter
Other contributor: University of Helsinki, HUS Abdominal Center




Date: 2019-09-04
Language: eng
Number of pages: 12
Belongs to series: Frontiers in Physiology
ISSN: 1664-042X
DOI: https://doi.org/10.3389/fphys.2019.01092
URI: http://hdl.handle.net/10138/305592
Abstract: Background: C-reactive protein level (CRP) and white blood cell count (WBC) have been variably used in clinical trials on acute pancreatitis (AP). We assessed their potential role. Methods: First, we investigated studies which have used CRP or WBC, to describe their current role in trials on AP. Second, we extracted the data of 1435 episodes of AP from our registry. CRP and WBC on admission, within 24 h from the onset of pain and their highest values were analyzed. Descriptive statistical tools as Kruskal-Wallis, Mann-Whitney U, Levene's F tests, Receiver Operating Characteristic (ROC) curve analysis and AUC (Area Under the Curve) with 95% confidence interval (CI) were performed. Results: Our literature review showed extreme variability of CRP used as an inclusion criterion or as a primary outcome or both in past and current trials on AP. In our cohort, CRP levels on admission poorly predicted mortality and severe cases of AP; AUC: 0.669 (CI:0.569-0.770); AUC:0.681 (CI: 0.601-0.761), respectively. CRP levels measured within 24 h from the onset of pain failed to predict mortality or severity; AUC: 0.741 (CI:0.627-0.854); AUC:0.690 (CI:0.586-0.793), respectively. The highest CRP during hospitalization had equally poor predictive accuracy for mortality and severity AUC:0.656 (CI:0.544-0.768); AUC:0.705 (CI:0.640-0.769) respectively. CRP within 24 h from the onset of pain used as an inclusion criterion markedly increased the combined event rate of mortality and severe AP (13% for CRP > 25 mg/l and 28% for CRP > 200 mg/l). Conclusion: CRP within 24 h from the onset of pain as an inclusion criterion elevates event rates and reduces the number of patients required in trials on AP.
Subject: acute pancreatitis
C-reactive protein
white blood cell
trial design
sample size calculation
C-REACTIVE PROTEIN
EARLY ENTERAL NUTRITION
SERUM INTERLEUKIN-6
SCORING SYSTEMS
DOUBLE-BLIND
SEVERITY
MARKERS
PREDICTION
3126 Surgery, anesthesiology, intensive care, radiology
1184 Genetics, developmental biology, physiology
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