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Artem Boyev*, Ahad M. Azimuddin, Timothy E. Newhook, Jessica E. Maxwell, Laura R. Prakash, Morgan L. Bruno, Whitney L. Dewhurst, Elsa M. Arvide, Yi-Ju Chiang, Michael P. Kim, Naruhiko Ikoma, Rebecca A. Snyder, Jeffrey E. Lee, Matthew Katz, Ching-Wei D. Tzeng
Surgical Oncology, The University of Texas MD Anderson Cancer Center Division of Surgery, Houston, TX

Post-pancreatoduodenectomy patients at our institution are managed on risk-stratified pancreatectomy care pathways preoperatively determined by risk of clinically relevant postoperative pancreatic fistula (CR-POPF). We previously published cut-off ranges for drain fluid amylase on postoperative day (POD) 1 (DFA1) and POD 3 (DFA 3) to encourage timely drain removal. The aim of this study was to validate and recalibrate our cut-off values using a prospective cohort of patients managed immediately after implementing those DFA thresholds.

We performed a single-institution prospective cohort study of consecutive patients who underwent pancreatoduodenectomy from DFA1/DFA3 threshold implementation in February 2019 to April 2022. Ninety-day postoperative complications were prospectively graded and reported according to the ACCORDION system and International Study Group on Pancreatic Surgery definitions. Patient characteristics, perioperative details, and DFA1/DFA3 (measured in U/L) were compared between care pathways. Receiver Operating Characteristic (ROC) curve analysis was performed to determine optimal cut-off values based on preoperative risk stratification.

In total, 267 patients underwent 228 (85%) open and 39 (15%) robotic procedures, with 173 (65%) patients stratified into low-risk and 94 (35%) into high-risk pathways. Seven (4%) low-risk patients and 21 (22%) high-risk patients developed CR-POPF. Of 147 patients with drains removed before/on POD3, only 1 (0.7%) developed CR-POPF in the prospective cohort recalibration. CR-POPF was excluded with 100% sensitivity if DFA1 <286 (area under curve, AUC=0.893, p=0.001) or DFA3 <97 (AUC=0.856, p=0.002) in low-risk patients. DFA1 <137 (AUC=0.786, p<0.001) or DFA3 <56 (AUC=0.819, p<0.001) were 100% sensitive in ruling out CR-POPF in high-risk patients. Our previous DFA1 cut-offs of 100 in low-risk patients and <26 in high-risk patients were 100% sensitive, while our DFA3 cut-offs of 300 (low-risk) and 200 (high-risk) had 57% and 91% sensitivity.

Risk-stratified post-pancreatoduodenectomy DFA thresholds can effectively and safely guide early POD1/POD3 drain removal. Previously identified cut-off values appear overly restrictive for DFA1 and overly liberal for DFA3. As a learning health system, we further propose recalibrating our drain removal thresholds to DFA1 ≤300, DFA3 ≤100 in low-risk patients and DFA1 ≤100, DFA3 ≤50 in high-risk patients. This methodology can be implemented at other centers to develop institution-specific criteria for early drain removal.

Table 1: Drain fluid amylase cut-offs on POD1 (DFA1) and POD3 (DFA3) for Low-Risk and High-Risk patients. The first "2019" value is the value currently in use. The next three "Proposed" values are cut-off values from analysis of the study recalibration data. Sensitivities of 100%, 90%, and 80% are displayed.

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