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P rocalcitonin R eveals E arly D ehiscence I n C oloretcal S urgery: the PREDICS Study

P rocalcitonin R eveals E arly D ehiscence I n C oloretcal S urgery: the PREDICS Study. V. GIACCAGLIA. PROCALCITONIN. 116 aminoacid protein, encoded by CALC1 gene produced and secreted by C-cells of the thyroid calcitonin pro-hormone, Ca metabolism.

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P rocalcitonin R eveals E arly D ehiscence I n C oloretcal S urgery: the PREDICS Study

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  1. Procalcitonin Reveals Early Dehiscence In ColoretcalSurgery: the PREDICS Study V. GIACCAGLIA

  2. PROCALCITONIN • 116 aminoacid protein, encoded by CALC1 gene • produced and secreted by C-cells of the thyroid • calcitonin pro-hormone, Ca metabolism Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

  3. PROCALCITONIN  PCT has a tissue-specific expression: • Normal conditions: • Production: only by C-cells of the thyroid • Low circulating levels of PCT (< 0.05 ng/ml) b) Bacterial infections: • Production: by all differentiated cells • High circulating levels of PCT (> 2 ng/ml) Maruna P et al. Physiol Res 2000; 49:S57-61

  4. PROCALCITONIN • KINETIC: • Induction: 2-3 hours after endotoxin release • Peak: 6-12 hours • Half-life: 24 hours Brunkhorst FM et al. Intens Care Med 1998; 24: 888-9

  5. PROCALCITONIN • SEPSIS BIOMARKER • diagnosis + prognosis: values related to sepsis severity • monitoring Antibiotic therapy efficacy • better sepsis biomarker than WBC, CRP and IL-6 • widely used in ICUs Meynaar IA at al. Crit Care Res Pract 2011; 2011:594645 Tromp M et al. J Infect 2012; 65:292-301

  6. STUDY BACKGROUND • Anastomotic leak (AL): one of the most feared complications in colorectal surgery (and it’s later than you think) • Laparoscopy and ERAS  lenght of stay reduction • Strong needing of an instrument that might help the surgeon to early diagnose AL PCT Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

  7. AIM OF THE STUDY To test if PROCALCITONIN might be an early and reliable biomarker of anastomotic leak after colorectal surgery Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

  8. SCIENTIFIC STUDIES Monocentric pilot study: 101 patients Multicentric PREDICS study: 504 patients Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

  9. PILOT STUDY Giaccaglia V, Salvi PF, Cunsolo GV, Sparagna A, Antonelli MS, Nigri G, Balducci G, Ziparo V J Crit Care 2014; 29:528-32

  10. PREDICS Procalcitonin Reveals Early Dehiscence in Colorectal Surgery ClinicalTrials.gov Identifier: NCT01817647 Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

  11. Giaccaglia V et al. Ann Surg 2016; 263:967-72

  12. PREDICS • Involved centers • S. Andrea University Hospital - Sapienza University of Rome, Italy: General & Emergency Surgery Units (V. Ziparo, G. Ramacciato, G. Balducci) • Monaldi Hospital - Naples, Italy: General Surgery Unit (F. Corcione) • University Hospital – Trieste, Italy: General Surgery Unit (N. De Manzini)

  13. MATERIALS • Inclusioncriteria: • patientsundergoingcolorectalsurgery • with an anastomosis being performed • in electivesetting • forcancer • laparoscopy (> 50%) or laparotomy Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

  14. MATERIALS • Measurement in 3rd and 5th POD of: • White blood cell count (WBC) • C-reactive protein (CRP) • Procalcitonin (PCT) • Anastomotic leak (AL) and all other complications were recorded Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

  15. MATERIALS • Start January 2013 504 • End Semptember 2014 patients Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

  16. RESULTS 5.6%

  17. RESULTS – PCT 3 • Mean PCT values,3rd POD • There is a statistically significant difference between AL group and other 2 groups (p<0.0001) 4.1 1.0 0.6 p<0.0001 (Kruskal-Wallis)

  18. RESULTS – PCT 5 • Mean PCT values,5th POD • There is a statistically significant difference between AL group and other 2 groups (p<0.0001) 3.2 0.9 0.3 p<0.0001 (Kruskal-Wallis)

  19. RESULTS – CRP 3 • Mean CRP values,3rd POD • There is a statistically significant difference between AL group and other 2 groups (p<0.0001) 22 12.2 9.7 p<0.0001

  20. RESULTS – CRP 5 • Mean CRP values,5thPOD • There is a statistically significant difference between AL group and other 2 groups (p<0.0001) 16.1 7.8 4.9 p<0.0001

  21. RESULTS – 3rdPOD Bio Summit & Molecular Biology Expo Dubai, October 10th 2016

  22. RESULTS – 5th POD Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

  23. RESULTS – 3rdPOD • ROC curve of biomarkers (PCT, CRP, WBC) • PCT has a similar AUC to CRP (0.775 vs 0.772), both much better than WBC (AUC 0.601) T3 PCT (AUC= 0.775) T3 CRP (AUC= 0.772) T3 WBC (AUC= 0.601)

  24. RESULTS – 5th POD • ROC curve of biomarkers (PCT, CRP, WBC) • PCT has a betterAUC vs CRP (0.862 vs 0.806), both better than WBC (AUC 0.611) T5 PCT (AUC= 0.862) T5CRP (AUC= 0.806) T5 WBC (AUC= 0.611)

  25. RESULTS - 3+5th POD • ROC curve PCT + CRP • PCT+CRP together give better diagnostic accuracy in 3rd POD (AUC 0.842) and in 5th POD in a statistically significant way (AUC 0.901)

  26. CONCLUSIONS • PREDICS study shows that Procalcitonin and CRP are both goodbiomarkers for anastomotic leak early diagnosis after colorectal surgery • On the contrary, WBC is not • PCT has better diagnostic value vs CRP in 5th POD (AUC 0.862 vs 0.806) • PCT + CRP together guarantee a very good diagnostic value, especially in 5th POD (AUC 0.901)

  27. CONCLUSIONS • PCT might be safely added to ERAS protocols, helping the surgeon to early diagnose anastomotic leak, before patients discharge Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

  28. Letterto the Editor Giaccaglia V, Antonelli MS, Salvi PF, Nigri G, Balducci G, Ramacciato G, Corcione F, de Manzini N. Reply to Letter: "A Different Approach to the Use of C-reactive Protein and Procalcitonin in Postoperative Infectious Complications". Ann Surg. 2016 May 26. [Epub ahead of print] Giaccaglia V, Antonelli MS, Salvi PF, Nigri G, Balducci G, Ramacciato G, de Manzini N, Corcione F. CRP Predicts Safe Patient Discharge after Colorectal Surgery: Reply. Ann Surg. 2016 Sep 14. [Epub ahead of print]

  29. FUTURE PROJECTS • PREGRAD: Procalcitonin REveals Good Recovery after AcuteDiverticulitis • S. Andrea University Hospital – Sapienza University of Rome, Italy (Prof. Ramacciato and Balducci) • Niguarda Hospital, Milan, Italy (Prof. Ferrari) • Riuniti Hospitals, Trieste, Italy (Prof. de Manzini) • Dijon University Hospital, France (Prof. Ortega Deballon) Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

  30. PREGRAD NCT 02817854 V. GIACCAGLIA

  31. PREGRAD • PCT for differential diagnosis between acute diverticulitis needing surgery or conservative therapy • NNT: > 500 patients in 1 year (start: June 2016) • Inclusion criteria: ER patients with CT diagnosis of acute diverticulitis Hinchey>2 • Exclusion criteria: age < 18 yrs, pregnancy, no CT diagnosis and/or Hinchey I Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

  32. PREGRAD • Data: patients characteristics (age, sex, comorbidities..), Hinchey, kind of treatment (conservative vs operative), outcomes, length of hospital stay • Measurement of: • a) PCT, CRP and WBC at arrival in ER • b) PCT, CRP and WBC: 2 and 3 days after admission Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

  33. PREGRAD • End-points: • 1) 30 days needing of surgery • 2) 30 days needing of percutaneous drain • 3) Length of hospital stay Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

  34. Other PCT studies • There are many other papers showing PCT usefulness in GI surgery: • pancreatic surgery (pancreatic fistula) • esophageal surgery (anastomotic leak) • bariatric surgery (gastric fistula) • acute appendicitis diagnosis • and many others

  35. PancreaticSurgery Giardino A et al. J Gastrointest Surg 2016; 20:1482-92

  36. PancreaticSurgery • 84 patients undergoing pancreaticoduodenectomy • 74% adenocarcinoma • PCT and CRP values: higher in the fistula group • Higher fistula risk: IF in 1st POD • PCT > 0.4 ng/ml (OR 5.62) • CRP > 9.2 mg/dl (OR 5.63) Giardino A et al. J Gastrointest Surg 2016; 20:1482-92

  37. EsophagealSurgery Hoeboer SH et al. J Gastrointest Surg 2015; 19:613-24

  38. EsophagealSurgery • Elective gastrectomy with gastric tube reconstruction • 45 patients • High PCT values in 1st and 3rd POD, diagnostic for leak: minumum AUROC 0.76, p<0.005 • High CRP values in 3rd POD, AL diagnosis: AUROC 0.78, p<0.002 Hoeboer SH et al. J Gastrointest Surg 2015; 19:613-24

  39. Sleeve gastrectomy Munoz JL et al. JACS 2016; 222:831-37

  40. Sleeve gastrectomy • 115 obese patients • undergoing sleeve gastrectomy • at 48 h, PCT > 0.95 ng/ml + CRP >15 mg/dl  100% sensitivity and 100% specificity for septic complications • Very useful for ERAS protocols Munoz JL et al. JACS 2016; 222:831-37

  41. Acute appendicitis Yamashita H et al. Med Sci 2016; 78:79-88

  42. Acute appendicitis • 63 patients, > 15 years old • PCT comparable to CRP for diagnosis of appendicitis without abscess • High PCT diagnostic values for appendicitis with abscess and/or perforation (PPV 73%) • PCT > 0.46 ng/ml : OR 30.3 vs PCT < 0.46 Yamashita H et al. Med Sci 2016; 78:79-88

  43. CONCLUSIONS • PCT is a good diagnostic tool for sepsis management, where its use is well-established • PCT, together with CRP, is an early and accurate biomarker of anastomotic leak after colorectal surgery and other GI surgeries • Ongoing trials that will tell us more regarding this interesting biomarker’s use Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

  44. THANK YOU Don’t beafraid tofail Be afraid toremain the same Thankyou! v.giaccaglia@gmail.com Bio Summit & Molecular Biology Expo Dubai, October 10th 2016 V. GIACCAGLIA

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