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PROPOSAL OF CLINICALLY USEFUL CRITERIA FOR EARLY DRAIN REMOVAL AFTER PANCREATICODUODENECTOMY AND BASED ON DATA AVAILABLE ON POSTOPERATIVE DAY 3
Toshimitsu Iwasaki*, Satoshi Nara, Yoji Kishi, Minoru Esaki, Kazuaki Shimada
Hepatobiliary and Pancreatic Surgery Division, National Cancer Center Hospital, Chou-ku, Tokyo, Japan

Background Postoperative pancreatic fistula (POPF) is a complication of significant clinical impact after pancreaticoduodenectomy (PD). Insertion of abdominal drains is considered to be mandatory to detect and treat POPF. Although the definition of POPF by international study group of pancreatic fistula (ISGPF) has been used worldwide, there is no consensus criterion for drain removal.
Objective The aim of this study was to establish a universally usable criterion for early drain removal after PD, based on factors available on postoperative day (POD) 3.
Method The postoperative complications of consecutive patients who underwent PD at our hospital from 2011 to 2015 were analyzed retrospectively. Pancreatico-jejunostomy was performed in all patients. Drains were inserted at the superior and inferior margin of the anastomosis. The occurrence of POPF was assessed according to the definition by ISGPF, and clinically relevant POPF (CR-POPF) was defined as grade B or C POPF. Analyzed predictors of CR-POPF included patient and tumor characteristics, operative factors and serum C-reactive protein (CRP) and drain amylase levels (d-AMY) on POD 1, 2 and 3. The cutoff values of continuous variables were determined by the receiver operating characteristic (ROC) analysis. Multivariate logistic regression analysis was performed to investigate the predictors of CR-POPF, and the constructed criteria for early drain removal was internally validated by 10-fold cross validation.
Results A total of 300 patients were included in this study. There was one postoperative death, and the median hospital stay was 22 days (range: 10-106). The incidence of POPF grade A, B and C were 6%, 27% and 7%, respectively. In both the CRP and d-AMY, the value on POD3 were the most significant predictors for CR-POPF. Multivariate analysis revealed that d-AMY on POD3 ≥350 IU/l (odds ratio [OR] 11.9), CRP on POD3 ≥15mg/dl (OR 6.7), preoperative endoscopic retrograde biliary drainage (OR 5.9), no portal vein resection (OR 3.1), and the diagnosis of non-PDAC (OR 2.5) were the significant predictors of CR-POPF. According to the most potent predictors (i.e. d-AMY on POD3 ≥350 IU/l and CRP on POD 3 ≥15mg/dl), the incidence of CR-POPF were 6%, 49% and 89% in patients with both negative (n=164), single positive (n=70) and both positive (n=66) patients, respectively. If we apply both negative for the two factors as criteria for non CR-POPF, the area under the ROC curve was 0.845, and the sensitivity, specificity were 79%, 90%, respectively. Ten-fold cross-validation showed the average area under the ROC curve, sensitivity, and specificity was 0.858, 75% and 92%, respectively.
Conclusion The criteria consisting of two factors available on POD3 has general versatility. Based on the low rate of CR-POPF in patients who are double negative for these criteria, early drain removal is considered to be safe.


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