Diagnostic Accuracy of Lipase as Early Predictor of Postoperative Pancreatic Fistula: Results from the LIPADRAIN study

Abstract

Objective: To evaluate the diagnostic accuracy of drain fluid lipase as an early predictor of postoperative pancreatic fistula and establish the most appropriate day for their measure.

Background: Clinically relevant postoperative pancreatic fistula remains a potentially life-threatening complication after pancreatic surgery. Early detection strategies remain key to reduce both the incidence and the burden of pancreatic fistula.

Methods: The LIPAse DRAIN (LIPADRAIN) study is a multicenter, prospective diagnostic study conducted in 7 tertiary university hospitals. Drain fluid values to detect clinically relevant postoperative pancreatic fistula from postoperative day 1 to postoperative day 6 were evaluated using receiver operating characteristic curve analysis. A biomarker was considered to be relevant for clinical use if its area under the curve (AUC) was greater than 0.75.

Results: Of the 625 patients included in the analysis, clinically relevant postoperative pancreatic fistula occurred in 203 (32%) patients. On postoperative days 3 and 4, drain fluid lipase was a reliable biomarker to detect clinically relevant postoperative pancreatic fistula (AUC: 0.761; 95% confidence interval [CI]: 0.761-0.799 and AUC: 0.784; 95% CI: 0.743-0.821, respectively). On postoperative day 3, with a threshold of 299 units/L, drain fluid lipase yielded a negative predictive value of 51%, sensitivity of 78%, and specificity of 63% for the detection of clinically relevant postoperative pancreatic fistula.

Conclusions: In this multicenter prospective study, drain fluid lipase is a reliable biomarker at postoperative days 3 and 4 for the diagnosis of clinically relevant postoperative pancreatic fistula after pancreatic surgery and should be systematically measured on postoperative day 3.

Keywords: Clinically relevant postoperative pancreatic fistula; Drain fluid amylase; Drain fluid lipase.

FIGURE 1.

LIPADRAIN study flowchart. Selection of patient included in the analyses.

FIGURE 2.

Daily median levels of DFL and DFA (IU/L) according to the presence or absence of CR-POPF.

FIGURE 3.

Outcomes from ROC curve analysis for drain fluid lipase. A, Receiver operating characteristic (ROC) curves for levels of drain fluid lipase at POD 1 (area under the curve [AUC] 0·756 [95% confidence interval: 0·714–0·797]), (B) at POD 3 (AUC: 0·761 [0·716–0·799]), (C) at POD 4 (AUC: 0·784 [0·743 to 0·821]), and (D) at POD 6 (AUC: 0·736 [0·693–0·778]). CR-POPF was the outcome variable.

FIGURE 4.

Outcomes from ROC curve analysis for drain fluid amylase. A, Receiver operating characteristic (ROC) curves for levels of drain fluid amylase at POD 1 (area under the curve [AUC]: 0·770 [95% confidence interval: 0·726–0·808]), (B) at POD 3 (AUC: 0·777 [0·737–0·816]), (C) at POD 4 (AUC: 0·784 [0·742–0·823]), and (D) at POD 6 (AUC: 0·728 [0·681–0·774]). CR-POPF was the outcome variable.