AUTHOR=Farkas Nelli , Hanák Lilla , Mikó Alexandra , Bajor Judit , Sarlós Patrícia , Czimmer József , Vincze Áron , Gódi Szilárd , Pécsi Dániel , Varjú Péter , Márta Katalin , Hegyi Péter Jenő , Erőss Bálint , Szakács Zsolt , Takács Tamás , Czakó László , Németh Balázs , Illés Dóra , Kui Balázs , Darvasi Erika , Izbéki Ferenc , Halász Adrienn , Dunás-Varga Veronika , Gajdán László , Hamvas József , Papp Mária , Földi Ildikó , Fehér Krisztina Eszter , Varga Márta , Csefkó Klára , Török Imola , Hunor-Pál Farkas , Mickevicius Artautas , Maldonado Elena Ramirez , Sallinen Ville , Novák János , Ince Ali Tüzün , Galeev Shamil , Bod Barnabás , Sümegi János , Pencik Petr , Szepes Attila , Szentesi Andrea , Párniczky Andrea , Hegyi Péter TITLE=A Multicenter, International Cohort Analysis of 1435 Cases to Support Clinical Trial Design in Acute Pancreatitis JOURNAL=Frontiers in Physiology VOLUME=10 YEAR=2019 URL=https://www.frontiersin.org/journals/physiology/articles/10.3389/fphys.2019.01092 DOI=10.3389/fphys.2019.01092 ISSN=1664-042X 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.