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Diagnostic Value of Serum Amylase Levels Indicating Computed Tomography-Defined Post-Endoscopic Retrograde Cholangiopancreatography Pancreatitis: A Prospective Multicenter Observational Study.

INATOMI Osamu 70530351 0000-0002-5837-6575 BAMBA Shigeki 40422901 0000-0002-4108-5894 NAKAI Yoshitaka KUSUMOTO Kiyonori KAWAKAMI Takumi SUZUKI Takahiro SUZUKI Azumi ENDOH Bunji OHTA Shinichi 30583637 INOUE Akitoshi 20803349 0000-0002-8610-2571 ITOKAWA Yoshio CHIKUGO Koki ANDOH Akira 90252395 0000-0001-8533-2669 MIZUMOTO Yoshinori TANAKA Kiyohito 滋賀医科大学

2020.08

概要

Objective:
Post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis involves persistent serum amylase levels of 3 times or more the standard upper limit. However, these criteria were mostly based on retrospective studies and not necessarily supported by diagnostic imaging. Our prospective study aimed to investigate cutoff serum amylase levels suggesting post-ERCP pancreatitis using computed tomography as the criterion standard.
Methods:
We prospectively followed 2078 cases. Computed tomography was performed in patients whose serum amylase levels exceeded the institutional upper limit 12 to 24 hours after ERCP. Two expert radiologists blindly assessed the images and judged the presence or absence of pancreatitis. Correlations between serum amylase levels with pancreatitis were investigated using receiver operating characteristic analysis.
Results:
Amylase levels increased in 416 (23.2%) of 1789 cases included, and 350 cases were analyzed using computed tomography. Post-endoscopic retrograde cholangiopancreatography pancreatitis was diagnosed in 12.0% (214/1789). The cutoff amylase levels for judging pancreatitis after 12 to 24 hours was 2.75 times higher than the institutional upper limit, with an area under the curve of 0.77.
Conclusions:
The appropriate cutoff serum amylase level for judging post-ERCP pancreatitis at 12 to 24 hours after ERCP was 2.75 times higher than the institutional upper limit. These results may clarify the definition of post-ERCP pancreatitis.

関連論文

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Figure legends

Figure 1. Flow diagram. There were 2078 patients who received ERCP. We excluded 289

cases (not reached the papilla in nine cases, post-biliary reconstruction in 63 cases, developed

pancreatitis before ERCP in 74 cases, elevated amylase before ERCP in 120 cases and ascites

or fluid collection due to biliary pancreatic cancer in 23 cases). Serum amylase level elevated

in 416 of 1789 cases enrolled. Sixty-six cases were excluded (CT is not performed CT at the

discretion of the physician in 63 cases, the patients refused CT examination in two cases and

bile duct perforation in one case). We analysed 350 cases using CT diagnosis of two expert

radiologists.

Figure 2. Receiver operating characteristic curves of serum amylase level at 2 h (A) and 12–

24 h (B) after ERCP for diagnosing post-ERCP pancreatitis.

AUC: area under the curve

TABLE 1. The Clinical Characteristics of the Patients Received CT Analysis

Male/female, n

Pancreatitis

(n = 214)

101/113

No Pancreatitis

(n = 136)

66/70

0.81

Age, median (range), y

72.8 (33–106)

73.1 (41–96)

0.78

1.56 (0.67)

1.68 (0.69)

0.10

CBD stone

77 (36.0)

72 (52.9)

Neoplasm

80 (37.4)

27 (19.9)

Others

57 (26.6)

37 (27.2)

Diagnostic

44 (20.6)

18 (13.2)

Therapeutic

170 (79.4)

118 (86.8)

136 (100)

33 (15.4)

0 (0)

123 (57.5)

0 (0)

28 (13.1)

0 (0)

30 (14.0)

0 (0)

ASA, mean (SD)

Disease, n (%)

Procedure, n (%)

CT grade *, n (%)

*CT grade according to CT severity index

Grade A; Normal pancreas

Grade B; Focal or diffuse enlargement of the pancreas

Grade C; Intrinsic pancreatic abnormalities associated with haziness and streaky densities

representing inflammatory changes in the peripancreatic fat

Grade D; Single ill-defined fluid collection

Grade E; Two or more poorly defined fluid collections or presence of gas adjacent to the

pancreas

TABLE 2. Sensitivity and Specificity of serum amylase at 2 and 12–24 h after ERCP for

post-ERCP pancreatitis

Serum

amylase

AUC

Sensitivity, %

Specificity, %

PLR

NLR

Cut-off value

(times the upper

limit of normal)

2h

0.63

45.2

79.3

2.19

0.69

2.73

12–24 h

0.77

70.1

75.7

2.88

0.39

2.75

AUC: Area under the curve; PLR: Positive likelihood ratio; NLR: Negative likelihood ratio

TABLE 3. Sensitivity and Specificity of Abdominal Pain and Serum Amylase Level at 2

and 12–24 h After the Examination for Post-ERCP Pancreatitis

Sensitivity, % Specificity, %

PLR

NLR

Abdominal pain at 2 h

19.2

91.2

2.11

0.89

Abdominal pain at 12–24 h

38.1

91.2

4.29

0.68

AMY > 2.75 and Abdominal pain

at 12–24 h

34.0

97.3

9.82

0.68

AMY > 2.75 or Abdominal pain

at 12–24 h

81.4

63.1

1.89

0.67

PLR: Positive likelihood ratio; NLR: Negative likelihood ratio

...

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