Test Performance Characteristics of Dynamic Liver Enzyme Trends in the Prediction of Choledocholithiasis
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Setting
2.2. Patients, Variables, and Outcomes
2.3. Statistical Analyses
3. Results
4. Discussion
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
Abbreviations
AE | adverse event |
ALP | alkaline phosphatase |
ALT | alanine transaminase |
ASGE | American Society for Gastrointestinal Endoscopy |
AST | aspartate transaminase |
CBD | common bile duct |
CDL | choledocholithiasis |
CT | computed tomography |
ERCP | endoscopic retrograde cholangiopancreatography |
ESGE | European Society of Gastrointestinal Endoscopy |
EUS | endoscopic ultrasound |
GGT | gamma-glutamyltransferase |
MRCP | magnetic resonance cholangiopancreatography |
NPV | negative predictive value |
PPV | positive predictive value |
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Probability | ASGE 2010 [3] | ASGE 2019 [6] | ESGE 2019 [7] |
---|---|---|---|
High (>50%) | (1) CBD stone on US and/or (2) Clinical ascending cholangitis and/or (3) Bilirubin > 4 mg/dL and/or (4) Bilirubin 1.8–4 mg/dL AND CBD > 6 mm on US | (1) CBD stone on US or cross-sectional imaging and/or (2) Clinical ascending cholangitis and/or (3) Bilirubin > 4 mg/dL AND CBD > 6 mm on US | (1) Clinical ascending cholangitis and/or (2) CBD stone on US |
Intermediate (10–50%) | (1) Bilirubin 1.8–4 mg/dL and/or (2) CBD > 6 mm on US and/or (3) Abnormal liver biochemical tests other than bilirubin and/or (4) Clinical gallstone pancreatitis and/or (5) Age > 55 years | (1) Bilirubin ≥ 1.8 mg/dL and/or (2) CBD > 6 mm on US and/or (3) Abnormal liver biochemical tests other than bilirubin and/or (4) Clinical gallstone pancreatitis and/or (5) Age > 55 years | (1) Any abnormal liver biochemical tests and/or (2) CBD > 6 mm on US |
Low (<10%) | None of the above predictors present | None of the above predictors present | None of the above predictors present |
Patients with Positive Diagnosis of Choledocholithiasis (n = 622) | Patients with Negative Diagnosis of Choledocholithiasis (n = 257) | p-Value | |
---|---|---|---|
Sex | 0.20 | ||
Female % (n) | 60.0 (373) | 55.3 (142) | |
Male % (n) | 40.0 (249) | 44.7 (115) | |
Mean age (SD) | 59.3 (21.2) | 66.0 (18.2) | <0.001 |
Procedure performed | <0.001 | ||
ERCP % (n) | 97.7 (608) | 86.0 (221) | |
EUS % (n) | 2.3 (14) | 14.0 (36) | |
Pre-Procedure Imaging | |||
Yes % (n) | 78.9 (472) | 82.9 (213) | |
No % (n) | 24.1 (150) | 17.1 (44) | |
Stone seen on imaging | <0.001 | ||
Yes % (n) | 54.7 (340) | 0.0 (0) | |
No % (n) | 45.3 (282) | 100.0 (257) | |
CBD > 6 mm | 0.04 | ||
Yes % (n) | 55.3 (344) | 47.9 (123) | |
No % (n) | 44.7 (278) | 52.1 (134) | |
Mean CBD size in mm, of those >6 mm (SD) | 12.4 (4.5) | 11.6 (3.8) | 0.01 |
Mean total bilirubin in µmol/L (SD) | 64.9 (62.1) | 60.6 (63.3) | 0.35 |
Mean ALT in U/L (SD) | 292.4 (346.6) | 283.6 (267.0) | 0.72 |
Mean ALP in U/L (SD) | 278.2 (256.5) | 261.1 (191.4) | 0.75 |
2010 ASGE guideline risk category | 0.01 | ||
High % (n) | 67.7 (421) | 57.6 (148) | |
Intermediate % (n) | 27.7 (172) | 33.5 (86) | |
Low % (n) | 4.7 (29) | 8.9 (23) |
Accuracy % (95% CI) | Sensitivity % (95% CI) | Specificity % (95% CI) | PPV % (95% CI) | NPV % (95% CI) | Patients Used in Models | |
---|---|---|---|---|---|---|
Bilirubin increase of at least 30% | 33.5 | 24.1 | 57.7 | 59.3 | 22.9 | |
(26.8–40.8) | (17.1–32.2) | (43.2–71.3) | (45.0–72.4) | (16.0–31.1) | 190 | |
Bilirubin increase of at least 50% | 31.9 | 19.5 | 63.5 | 57.8 | 23.6 | |
(25.2–39.1) | (13.2–27.3) | (49.0–76.4) | (42.2–72.3) | (16.8–31.5) | 190 | |
ALP increase of at least 30% | 32.2 | 12.2 | 82.7 | 64.0 | 27.2 | |
(25.5–39.5) | (7.1–19.1) | (69.7–91.8) | (42.5–82.0) | (20.4–34.9) | 187 | |
ALP increase of at least 50% | 29.5 | 6.1 | 88.5 | 57.1 | 27.2 | |
(23.0–36.7) | (2.7–11.7) | (76.6–95.6) | (28.9–82.3) | (20.7–34.6) | 187 | |
ALT increase of at least 30% | 34.6 | 19.8 | 72.5 | 65.0 | 26.1 | |
(27.7–42.0) | (13.4–27.7) | (58.3–84.1) | (48.3–79.4) | (19.1–34.1) | 186 | |
ALT increase of at least 50% | 34.1 | 16.0 | 80.4 | 67.7 | 27.2 | |
(27.2–41.4) | (10.2–23.5) | (66.9–90.2) | (48.6–83.3) | (20.2–35.0) | 186 | |
Bilirubin OR ALT increase of at least 30% | 37.4 | 32.0 | 51.0 | 62.1 | 23.0 | |
(30.3–45.0) | (24.1–40.9) | (36.6–65.2) | (49.3–73.8) | (15.6–31.9) | 183 | |
Bilirubin OR ALT increase of at least 50% | 34.6 | 25.0 | 58.8 | 60.4 | 23.8 | |
(27.7–42.1) | (17.8–33.4) | (44.2–72.4) | (46.0–73.5) | (16.7–32.2) | 183 | |
Bilirubin AND ALT increase of at least 30% | 31.3 | 12.5 | 78.4 | 59.3 | 26.3 | |
(24.6–38.6) | (7.3–19.5) | (64.7–88.7) | (38.8–77.6) | (19.5–34.1) | 183 | |
Bilirubin AND ALT increase of at least 50% | 31.8 | 10.9 | 84.3 | 63.6 | 27.4 | |
(25.1–39.2) | (6.1–17.7) | (71.4–93.0) | (40.7–82.8) | (20.6–35.1) | 183 | |
Any enzyme increase of at least 30% | 37.9 | 34.7 | 46.0 | 61.4 | 22.1 | |
(30.7–45.6) | (26.4–43.7) | (31.8–60.7) | (49.0–72.8) | (14.6–31.3) | 177 | |
Any enzyme increase of at least 50% | 35.1 | 25.8 | 80.4 | 60.4 | 24.0 | |
(28.0–42.6) | (18.4–34.4) | (66.9–90.2) | (46.0–73.5) | (16.7–32.6) | 177 |
Accuracy % (95% CI) | Sensitivity % (95% CI) | Specificity % (95% CI) | PPV % (95% CI) | NPV % (95% CI) | Patients Used in Models | |
---|---|---|---|---|---|---|
Bilirubin decrease of at least 30% | 61.6 | 21.2 | 77.4 | 26.8 | 71.5 | |
(54.2–68.7) | (11.1–34.7) | (69.4–84.2) | (14.2–42.9) | (63.4–78.7) | 190 | |
Bilirubin decrease of at least 50% | 68.6 | 9.6 | 91.7 | 31.2 | 72.2 | |
(61.4–75.3) | (3.2–21.0) | (85.7–95.8) | (11.0–58.7) | (64.8–78.8) | 190 | |
ALP decrease of at least 30% | 67.2 | 1.9 | 93.1 | 10.0 | 70.5 | |
(59.9–74.0) | (0.0–10.3) | (87.4–96.8) | (0.3–44.5) | (63.1–77.2) | 187 | |
ALP decrease of at least 50% | 71.6 | 0.0 | 100.0 | N/R | 71.6 | |
(64.5–78.0) | (0.0–6.8) | (97.2–100.0) | (64.5–78.0) | 187 | ||
ALT decrease of at least 30% | 55.5 | 19.6 | 69.5 | 20.0 | 68.9 | |
(48.0–62.8) | (9.8–33.1) | (60.8–77.2) | (10.0–33.7) | (60.3–76.7) | 186 | |
ALT decrease of at least 50% | 64.8 | 3.9 | 88.5 | 11.8 | 70.3 | |
(57.4–71.8) | (0.5–13.5) | (81.8- 93.4) | (1.5–36.4) | (62.7–77.2) | 186 | |
Bilirubin OR ALT decrease of at least 30% | 52.0 | 35.3 | 58.6 | 25.4 | 69.4 | |
(44.4–59.5) | (22.4–49.9) | (49.6–67.2) | (15.8–37.1) | (59.8–77.9) | 183 | |
Bilirubin OR ALT decrease of at least 50% | 62.0 | 11.8 | 82.0 | 20.7 | 69.7 | |
(54.5–69.1) | (4.4–23.9) | (74.3–88.3) | (8.0–39.7) | (61.5–77.0) | 183 | |
Bilirubin AND ALT decrease of at least 30% | 64.8 | 3.9 | 89.1 | 12.5 | 69.9 | |
(57.3–71.8) | (0.5–13.5) | (82.3–93.9) | (1.6–38.3) | (62.3–76.9) | 183 | |
Bilirubin AND ALT decrease of at least 50% | 70.4 | 0.0 | 98.4 | 0.0 | 71.2 | |
(63.1–77.0) | (0.0–7.0) | (94.5–99.8) | (0.0–8.4) | (63.9–77.7) | 183 | |
Any enzyme decrease of at least 30% | 51.1 | 36.0 | 57.3 | 25.4 | 68.9 | |
(43.5–58.8) | (22.9–50.8) | (48.1–66.1) | (15.8–37.1) | (59.1–77.7) | 177 | |
Any enzyme decrease of at least 50% | 61.5 | 12.0 | 81.5 | 20.7 | 69.7 | |
(53.8–68.8) | (4.5–24.3) | (73.5–87.9) | (8.0–39.7) | (61.5–77.0) | 177 |
Patients with Choledocholithiasis/Total Patients in Risk Category | Sensitivity % (95% CI) | Specificity % (95% CI) | PPV % (95% CI) | NPV % (95% CI) | |
---|---|---|---|---|---|
ASGE 2010—high risk [3] | 67.7 | 57.6 | 74.0 | 35.2 | |
421/569 | (64–71.4) | (36.4–48.5) | (70.4–77.6) | (29.8–40.5) | |
ASGE 2010—intermediate risk [3] | 27.7 | 33.5 | 66.7 | 27.5 | |
172/258 | (24.1–31.2) | (60.8–72.3) | (60.9–72.4) | (24–31.1) | |
ASGE 2019—high risk [6] | 59.5 | 39.7 | 78.4 | 38.1 | |
370/472 | (55.6–63.3) | (54.3–66.3) | (74.7–82.1) | (33.3–42.8) | |
ASGE 2019—intermediate risk [6] | 35.9 | 54.1 | 61.6 | 22.8 | |
223/362 | (32.1–39.6) | (39.8–52) | (56.6–66.6) | (19.2–26.4) | |
ESGE 2019—high risk [7] | 46.3 | 19.5 | 85.2 | 38.3 | |
288/338 | (42.4–50.2) | (75.7–85.4) | (81.4–89) | (34.2–42.4) | |
ESGE 2019—intermediate risk [7] | 37.6 | 66.1 | 57.9 | 18.3 | |
243/404 | (33.8–41.4) | (28.1–39.6) | (53.1–62.7) | (14.8–21.8) |
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Lei, Y.; Lethebe, B.C.; Wishart, E.; Bazerbachi, F.; Elmunzer, B.J.; Thosani, N.; Buxbaum, J.L.; Chen, Y.-I.; Bass, S.; Cole, M.J.; et al. Test Performance Characteristics of Dynamic Liver Enzyme Trends in the Prediction of Choledocholithiasis. J. Clin. Med. 2022, 11, 4575. https://doi.org/10.3390/jcm11154575
Lei Y, Lethebe BC, Wishart E, Bazerbachi F, Elmunzer BJ, Thosani N, Buxbaum JL, Chen Y-I, Bass S, Cole MJ, et al. Test Performance Characteristics of Dynamic Liver Enzyme Trends in the Prediction of Choledocholithiasis. Journal of Clinical Medicine. 2022; 11(15):4575. https://doi.org/10.3390/jcm11154575
Chicago/Turabian StyleLei, Yang, B. Cord Lethebe, Erin Wishart, Fateh Bazerbachi, B. Joseph Elmunzer, Nirav Thosani, James L. Buxbaum, Yen-I Chen, Sydney Bass, Martin J. Cole, and et al. 2022. "Test Performance Characteristics of Dynamic Liver Enzyme Trends in the Prediction of Choledocholithiasis" Journal of Clinical Medicine 11, no. 15: 4575. https://doi.org/10.3390/jcm11154575
APA StyleLei, Y., Lethebe, B. C., Wishart, E., Bazerbachi, F., Elmunzer, B. J., Thosani, N., Buxbaum, J. L., Chen, Y.-I., Bass, S., Cole, M. J., Turbide, C., Brenner, D. R., Heitman, S. J., Mohamed, R., & Forbes, N. (2022). Test Performance Characteristics of Dynamic Liver Enzyme Trends in the Prediction of Choledocholithiasis. Journal of Clinical Medicine, 11(15), 4575. https://doi.org/10.3390/jcm11154575