Evaluation of the Cell Block Method Using Overnight-Stored Bile for Malignant Biliary Stricture Diagnosis
Abstract
:Simple Summary
Abstract
1. Introduction
2. Materials and Methods
2.1. Study Design
2.2. Patients and Procedures
2.3. Pathological Diagnosis
2.4. Number of Malignant Cells in the CB and Biopsy Specimens
2.5. Immunohistochemistry
2.6. Final Diagnosis
2.7. Endpoint
2.8. Statistical Analysis
3. Results
3.1. Basic Characteristics of the Patients
3.2. Endoscopic Procedure and Findings
3.3. Cancer Detectability
3.4. Malignant Cell Count
3.5. Immunohistochemistry
3.6. Adverse Events
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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n = 60 | |
---|---|
Sex, female/Male n (%) | 23 (38.3%)/37 (61.7%) |
Age (years), median (range) | 76 (49–98) |
Endoscopic sphincterotomy | 46 (76.7%) |
Diameter of ENBD tube 5 Fr:6 Fr (number) | 32:28 |
Eastern cooperative oncology group performance status (ECOG-PS), n (%) | |
0 | 28 |
1 | 16 |
2 | 13 |
3 | 3 |
Alanine aminotransferase (AST), median (range), IU/L | 89 (13–540) |
Aspartate aminotransferase (ALT), median (range), IU/L | 119 (9–1246) |
Total bilirubin level, median (range), mg/dL | 1.5 (0.3–34.2) |
White blood count, median (range)/µL | 6490 (2890–20750) |
Neutrophils, median (range)/µL | 4150 (1030–19090) |
Hemoglobin, median (range), g/dL | 12.0 (8.7–15.8) |
Location of stricture in the bile duct | |
Intrahepatic | 6 (10.0%) |
Portal | 16 (26.7%) |
Superior | 17 (28.3%) |
Inferior | 21 (35.0%) |
Type of malignancy, n (%) | |
Extrahepatic cholangiocarcinoma | 26 (43.4%) |
Gallbladder cancer | 7 (11.7%) |
Ampullary cancer | 5 (8.4%) |
Pancreatic head cancer | 4 (6.6%) |
Intrahepatic cholangiocarcinoma | 2 (3.3%) |
Hepatocellular carcinoma | 1 (1.7%) |
Benign, n (%) | |
Primary sclerosing cholangitis | 4 (6.6%) |
IgG4-related sclerosing cholangitis | 4 (6.6%) |
Bile duct hamartoma | 1 (1.7%) |
Liver cirrhosis | 1 (1.7%) |
Acalculous cholecystitis | 1 (1.7%) |
Other inflammatory non-malignant stenosis | 3 (5.0%) |
Withdrawal case due to patient’s will | 1 (1.7%) |
Overall (n = 59) | CB Method, n (%) | Bile Cytology, n (%) | p-Value |
---|---|---|---|
Malignant (n = 45) | 28 (62.2%) | 17 (37.8%) | 0.0344 |
Extrahepatic cholangiocarcinoma (n = 26) | 15 (57.7%) | 12 (46.2%) | 0.58 |
Gallbladder cancer (n = 7) | 7 (100%) | 2 (28.6%) | 0.0210 |
Ampullary cancer (n = 5) | 3 (60.0%) | 1 (20.0%) | 0.52 |
Pancreatic head cancer (n = 4) | 1 (25.0%) | 1 (25.0%) | 1.0 |
Intrahepatic cholangiocarcinoma (n = 2) | 2 (100%) | 1 (50.0%) | 1.0 |
Hepatic cell carcinoma (n = 1) | 0 (0%) | 0 (0%) | 1.0 |
Benign (n = 14) | 14 (100%) | 14 (100%) | 1.0 |
CB Method | First Bile Cytology | Multiple Bile Cytology | Biopsy | |
---|---|---|---|---|
Sensitivity | 62.2% (28/45) | 37.8% (17/45) * | 60.0% (27/45) | 65.8% (25/38) |
Specificity | 100% (14/14) | 100% (14/14) | 100% (14/14) | 100% (9/9) |
PPV | 100% (28/28) | 100% (17/17) | 100% (27/27) | 100% (25/25) |
NPV | 45.2% (14/31) | 33.3% (14/42) | 43.8% (14/32) | 40.9% (9/22) |
Accuracy | 71.2% (42/59) | 52.5% (31/59) † | 69.5% (41/59) | 72.3% (34/47) |
CB Method | ||
---|---|---|
Malignant (n = 28) | False Negative (n = 17) | |
Biopsy | ||
Malignant (n = 25) | 19 | 6 |
False negative (n = 13) | 7 | 6 |
Unperformed case (n = 7) | 2 | 5 |
Case | Surgical Specimen (Maspin/p53) | CB Method (Maspin/p53) | Biopsy (Maspin/p53) |
---|---|---|---|
1 | 2 + /1+ | 1 + /0 | 2 + /1+ |
2 | 2 + /1+ | 3 + /1+ | 3 + /1+ |
3 | 2 + /2+ | 3 + /2+ | 2 + /3+ |
4 | 2 + /1+ | 2 + /0 | N.A. |
5 | 1 + /1+ | 1 + /0 | N.A. |
6 | 3 + /1+ | 3 + /2+ | N.A. |
7 | 3 + /2+ | 2 + /3+ | N.A. |
8 | 3 + /1+ | 2 + /2+ | N.A. |
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Okuno, M.; Mukai, T.; Iwata, K.; Watanabe, N.; Tanaka, T.; Iwasa, T.; Shimojo, K.; Ohashi, Y.; Takagi, A.; Ito, Y.; et al. Evaluation of the Cell Block Method Using Overnight-Stored Bile for Malignant Biliary Stricture Diagnosis. Cancers 2022, 14, 2701. https://doi.org/10.3390/cancers14112701
Okuno M, Mukai T, Iwata K, Watanabe N, Tanaka T, Iwasa T, Shimojo K, Ohashi Y, Takagi A, Ito Y, et al. Evaluation of the Cell Block Method Using Overnight-Stored Bile for Malignant Biliary Stricture Diagnosis. Cancers. 2022; 14(11):2701. https://doi.org/10.3390/cancers14112701
Chicago/Turabian StyleOkuno, Mitsuru, Tsuyoshi Mukai, Keisuke Iwata, Naoki Watanabe, Takuji Tanaka, Taisei Iwasa, Kota Shimojo, Yosuke Ohashi, Akihiro Takagi, Yuki Ito, and et al. 2022. "Evaluation of the Cell Block Method Using Overnight-Stored Bile for Malignant Biliary Stricture Diagnosis" Cancers 14, no. 11: 2701. https://doi.org/10.3390/cancers14112701