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Jenny H. Chang*, Mir Shanaz Hossain, Kathryn A. Stackhouse, Chase J. Wehrle, Daniel Joyce, Robert Simon, Toms Augustin, R Matthew Walsh, Samer A. Naffouje
Surgery, Cleveland Clinic, Cleveland, OH

Background: Drain amylase has been thoroughly investigated as a predictor of postoperative pancreatic fistula (POPF) after pancreaticoduodenectomy (PD). The use of drain amylase on day 1 (DA-D1) after PD to predict occurrence of POPF has been controversial with various cutoffs proposals. The purpose of this study is to evaluate the optimal DA-D1 level to predict clinically relevant postoperative pancreatic fistula (CR-POPF) in a large population-based cohort.

Methods: The National Surgical Quality Improvement Program (NSQIP) database between 2014-2020 was queried for patients who underwent elective PD for benign and malignant indications. Patients with the following data were included in the analysis: sex, body mass index (BMI), DA-D1, preoperative bilirubin, duct size, gland texture, length of stay (LOS), duration of surgical drain, and post-operative complications to determine development of POPF and CR-POPF per International Study Group of Pancreatic Fistula guidelines. Receiver operative curve (ROC) and Youden's index were used to assess the predictive performance and optimal cutoff points for DA-D1 to predict CR-POPF. Our proposed DA-D1 value was then confirmed with a backward stepwise multivariable logistic regression to determine hazard ratios (HR) for CR-POPF and applied using conditional logistics regression to subgroups based on modified fistula risk score (FRS) as developed from the 2012 NSQIP pancreatectomy database study.

Results: A total of 47,275 cases were identified, of which 6,087 met inclusion criteria. The mean age was 66.7±12.5 years, mean BMI 27.4±6.0, and 47.4% were females. Majority of patients underwent open PD (n=5,156, 84.7%). Mean DA-D1 was 2,897±8,636 U/L and the median duration pf drain was 5 days. POPF was documented in 877 (14.4%) patients; 544 (8.9%) were CR-POPF. ROC for DA-D1 for any POPF had an AUC of 0.807 (95% CI 0.793-0.822), and an AUC of 0.779 for CR-POPF (95% CI 0.759-0.798). Youden's index for the CR-POPF ROC coordinates was determined at a 77.6% sensitivity and 66.3% specificity, which correspond to DA-D1 values of ≥720 U/L as an optimal cutoff. CR-POPF was higher for patients with DA-D1 ≥720 U/L (HR 4.6; p=0.001), male sex (HR 1.37; p=0.001), high BMI (HR 1.57; p<0.001), small duct size of 3-6mm (HR 1.41; p=0.041) and <3mm (HR=1.75; p=0.004), and soft gland (HR 1.55; p<0.001). Patients with a negligible, low, intermediate, and high FRS had respectively 2%, 5%, 10%, and 19% rate of CR-POPF. Comparison of CR-POPF rates in each FRS category based on DA-D1 cut-off of 720 U/L is demonstrated in Figure 1.

Conclusion: A level of 720 U/L DA-D1 after elective PD is a clinically useful predictor of CR-POPF for patients in all FRS categories. For patients with low to intermediate FRS, further research is needed to affirm DA-D1<720 U/L as a part of enhanced recovery after surgery protocols for safe early drain removal.

Figure 1: Comparison of CR-POPF rates in each FRS category based on the DA-D1 cutoff of 720 U/L. DA-D1: Drain Amylase on Day 1; CR-POPF: Clinically Relevant Postoperative Pancreatic Fistula; FRS: Fistula Risk Score.

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