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

. 2019 ; 10 () : 1092. [epub] 20190904

Status PubMed-not-MEDLINE Jazyk angličtina Země Švýcarsko Médium electronic-ecollection

Typ dokumentu časopisecké články

Perzistentní odkaz   https://www.medvik.cz/link/pmid31551798

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.

1st Department of Medicine University of Szeged Szeged Hungary

Bajcsy Zsilinszky Hospital Budapest Hungary

Borsod Abaúj Zemplén County Hospital University Teaching Hospital Miskolc Hungary

Centrum Péče o Zažívací Trakt Vítkovická Nemocnice a s Ostrava Czechia

Clinical Medicine Doctoral School University of Szeged Szeged Hungary

Consorci Sanitari del Garraf Barcelona Spain

County Emergency Clinical Hospital University of Medicine Pharmacy Sciences and Technology of Targu Mures Targu Mures Romania

Department of Gastroenterology 1st Department of Medicine Medical School University of Pécs Pécs Hungary

Department of Gastroenterology Bács Kiskun County Hospital Kecskemét Hungary

Department of Internal Medicine Division of Gastroenterology Faculty of Medicine University of Debrecen Debrecen Hungary

Department of Transplantation and Liver Surgery Helsinki University Central Hospital University of Helsinki Helsinki Finland

Dr Bugyi István Hospital Szentes Hungary

Dr Réthy Pál Hospital Békéscsaba Hungary

Heim Pál National Institute of Pediatrics Budapest Hungary

Institute for Translational Medicine Medical School University of Pécs Pécs Hungary

Institute of Bioanalysis Medical School University of Pécs Pécs Hungary

Momentum Gastroenterology Multidisciplinary Research Group Hungarian Academy of Sciences University of Szeged Szeged Hungary

Pándy Kálmán Hospital of County Békés Gyula Hungary

Saint Luke's Clinical Hospital St Petersburg Russia

School of Medicine Hospital of Bezmialem Vakif University Istanbul Turkey

Szent György University Teaching Hospital Fejér County Székesfehérvár Hungary

Vilnius University Hospital Santariskiu Klinikos Vilnius Lithuania

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Banks P. A., Bollen T. L., Dervenis C., Gooszen H. G., Johnson C. D., Sarr M. G., et al. (2013). Classification of acute pancreatitis–2012: revision of the Atlanta classification and definitions by international consensus. Gut 62 102–111. 10.1136/gutjnl-2012-302779 PubMed DOI

Cho J. H., Kim T. N., Chung H. H., Kim K. H. (2015). Comparison of scoring systems in predicting the severity of acute pancreatitis. World J. Gastroenterol. 21 2387–2394. 10.3748/wjg.v21.i8.2387 PubMed DOI PMC

Choosakul S., Harinwan K., Chirapongsathorn S., Opuchar K., Sanpajit T., Piyanirun W., et al. (2018). Comparison of normal saline versus Lactated Ringer’s solution for fluid resuscitation in patients with mild acute pancreatitis, a randomized controlled trial. Pancreatology 10.1016/j.pan.2018.04.016 [Epub ahead of print]. PubMed DOI

Cui H. X., Xu J. Y., Li M. Q. (2014). Efficacy of continuous renal replacement therapy in the treatment of severe acute pancreatitis associated acute respiratory distress syndrome. Eur. Rev. Med. Pharmacol. Sci. 18 2523–2526. PubMed

de Beaux A. C., Goldie A. S., Ross J. A., Carter D. C., Fearon K. C. (1996). Serum concentrations of inflammatory mediators related to organ failure in patients with acute pancreatitis. Br. J. Surg. 83 349–353. 10.1002/bjs.1800830317 PubMed DOI

de-Madaria E., Herrera-Marante I., González-Camacho V., Bonjoch L., Quesada-Vázquez N., Almenta-Saavedra I., et al. (2018). Fluid resuscitation with lactated Ringer’s solution vs normal saline in acute pancreatitis: a triple-blind, randomized, controlled trial. United Eur. Gastroenterol. J. 6 63–72. 10.1177/2050640617707864 PubMed DOI PMC

Dervenis C., Johnson C. D., Bassi C., Bradley E., Imrie C. W., McMahon M. J., et al. (1999). Diagnosis, objective assessment of severity, and management of acute pancreatitis. Santorini consensus conference. Int. J. Pancreatol. 25 195–210. PubMed

Gompertz M., Lara I., Fernandez L., Miranda J. P., Mancilla C., Watkins G., et al. (2013). [Mortality of acute pancreatitis in a 20 years period]. Rev. Med. Chil. 141 562–567. 10.4067/S0034-98872013000500002 PubMed DOI

Gross V., Schölmerich J., Leser H. G., Salm R., Lausen M., Rückauer K., et al. (1990). Granulocyte elastase in assessment of severity of acute pancreatitis. Comparison with acute-phase proteins C-reactive protein, alpha 1-antitrypsin, and protease inhibitor alpha 2-macroglobulin. Dig. Dis. Sci. 35 97–105. 10.1007/bf01537230 PubMed DOI

Guo J., Xue P., Yang X. N., Lin Z. Q., Chen Y., Jin T., et al. (2013). The effect of Chaiqin Chengqi Decoction () on modulating serum matrix metalloproteinase 9 in patients with severe acute pancreatitis. Chin. J. Integr. Med. 19 913–917. 10.1007/s11655-013-1653-x PubMed DOI

Heath D. I., Cruickshank A., Gudgeon M., Jehanli A., Shenkin A., Imrie C. W. (1993). Role of interleukin-6 in mediating the acute phase protein response and potential as an early means of severity assessment in acute pancreatitis. Gut 34 41–45. 10.1136/gut.34.1.41 PubMed DOI PMC

Jin Z., Wang Z., Wang J. (2018). Early enteral nutrition prevent acute pancreatitis from deteriorating in obese patients. J. Clin. Gastroenterol. 10.1097/MCG.0000000000001117 [Epub ahead of print]. PubMed DOI

Leser H. G., Gross V., Scheibenbogen C., Heinisch A., Salm R., Lausen M., et al. (1991). Elevation of serum interleukin-6 concentration precedes acute-phase response and reflects severity in acute pancreatitis. Gastroenterology 101 782–785. 10.1016/0016-5085(91)90539-w PubMed DOI

Louie B. E., Noseworthy T., Hailey D., Gramlich L. M., Jacobs P., Warnock G. L. (2004). MacLean-Mueller prize enteral or parenteral nutrition for severe pancreatitis: a randomized controlled trial and health technology assessment. Can. J. Surg. 2005 298–306. PubMed PMC

Mayer A. D., McMahon M. J., Bowen M., Cooper E. H. (1984). C reactive protein: an aid to assessment and monitoring of acute pancreatitis. J. Clin. Pathol. 37 207–211. 10.1136/jcp.37.2.207 PubMed DOI PMC

Neoptolemos J. P., Kemppainen E. A., Mayer J. M., Fitzpatrick J. M., Raraty M. G., Slavin J., et al. (2000). Early prediction of severity in acute pancreatitis by urinary trypsinogen activation peptide: a multicentre study. Lancet 355 1955–1960. 10.1016/s0140-6736(00)02327-8 PubMed DOI

Parniczky A., Kui B., Szentesi A., Balázs A., Szücs Á, Mosztbacher D., et al. (2016). Prospective, multicentre, nationwide clinical data from 600 cases of acute Pancreatitis. PLoS One 11:e0165309. 10.1371/journal.pone.0165309 PubMed DOI PMC

Pearce C. B., Sadek S. A., Walters A. M., Goggin P. M., Somers S. S., Toh S. K., et al. (2006). A double-blind, randomised, controlled trial to study the effects of an enteral feed supplemented with glutamine, arginine, and omega-3 fatty acid in predicted acute severe pancreatitis. Jop 7 361–371. PubMed

Peery A. F., Dellon E. S., Lund J., Crockett S. D., McGowan C. E., Bulsiewicz W. J., et al. (2012). Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology 143 1179.e3–1187.e3. 10.1053/j.gastro.2012.08.002 PubMed DOI PMC

Pezzilli R., Billi P., Miniero R., Fiocchi M., Cappelletti O., Morselli-Labate A. M., et al. (1995). Serum interleukin-6, interleukin-8, and beta 2-microglobulin in early assessment of severity of acute pancreatitis. Comparison with serum C-reactive protein. Dig. Dis. Sci. 40 2341–2348. 10.1007/bf02063235 PubMed DOI

Pongprasobchai S., Jianjaroonwong V., Charatcharoenwitthaya P., Komoltri C., Tanwandee T., Leelakusolvong S., et al. (2010). Erythrocyte sedimentation rate and C-reactive protein for the prediction of severity of acute pancreatitis. Pancreas 39 1226–1230. 10.1097/MPA.0b013e3181deb33e PubMed DOI

Powell J. J., Murchison J. T., Fearon K. C., Ross J. A., Siriwardena A. K. (2000). Randomized controlled trial of the effect of early enteral nutrition on markers of the inflammatory response in predicted severe acute pancreatitis. Br. J. Surg. 87 1375–1381. 10.1046/j.1365-2168.2000.01558.x PubMed DOI

Puolakkainen P., Valtonen V., Paananen A., Schröder T. (1987). C-reactive protein (CRP) and serum phospholipase A2 in the assessment of the severity of acute pancreatitis. Gut 28 764–771. 10.1136/gut.28.6.764 PubMed DOI PMC

Sun J. K., Mu X. W., Li W. Q., Tong Z. H., Li J., Zheng S. Y. (2013). Effects of early enteral nutrition on immune function of severe acute pancreatitis patients. World J. Gastroenterol. 19 917–922. 10.3748/wjg.v19.i6.917 PubMed DOI PMC

Szentesi A., Toth E., Balint E., Fanczal J., Madácsy T., Laczkó D., et al. (2016). Analysis of research activity in gastroenterology: pancreatitis is in real danger. PLoS One 11:e0165244. 10.1371/journal.pone.0165244 PubMed DOI PMC

Vasudevan S., Goswami P., Sonika U., Thakur B., Sreenivas V., Saraya A. (2018). Comparison of various scoring systems and biochemical markers in predicting the outcome in Acute Pancreatitis. Pancreas 47 65–71. 10.1097/MPA.0000000000000957 PubMed DOI

Vege S. S., Atwal T., Bi Y., Chari S. T., Clemens M. A., Enders F. T. (2015). Pentoxifylline treatment in severe acute pancreatitis: a pilot, double-blind, placebo-controlled, randomized trial. Gastroenterology 149 318–320. 10.1053/j.gastro.2015.04.019 PubMed DOI

Wilson C., Heads A., Shenkin A., Imrie C. W. (1989). C-reactive protein, antiproteases and complement factors as objective markers of severity in acute pancreatitis. Br. J. Surg. 76 177–181. 10.1002/bjs.1800760224 PubMed DOI

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