TY - JOUR
T1 - Hysteroscopic Photodynamic Diagnosis Using 5-Aminolevulinic Acid
T2 - A High-Sensitivity Diagnostic Method for Uterine Endometrial Malignant Diseases
AU - Matoba, Yusuke
AU - Banno, Kouji
AU - Kisu, Iori
AU - Kobayashi, Yusuke
AU - Tsuji, Kosuke
AU - Nagai, Shimpei
AU - Yamagami, Wataru
AU - Nakamura, Masaru
AU - Tominaga, Eiichiro
AU - Kawaida, Miho
AU - Aoki, Daisuke
N1 - Funding Information:
Supported by the Japanese Foundation for Research and Promotion of Endoscopy (JFE) grant.
Funding Information:
We thank Ryota Ishii (Biostatistics Unit, Clinical and Translational Research Center, Keio University Hospital) for their advice and review on statistical analysis.
Publisher Copyright:
© 2019 AAGL
PY - 2020/7/1
Y1 - 2020/7/1
N2 - Study Objective: To examine the diagnostic accuracy of hysteroscopic photodynamic diagnosis (PDD) using 5-aminolevulinic acid (5ALA) in patients with endometrial cancer and premalignant atypical endometrial hyperplasia. Design: A single-center, open-label, exploratory intervention study. Setting: University Hospital in Japan. Patients: Thirty-four patients who underwent hysteroscopic resection in the Department of Obstetrics and Gynecology at Keio University Hospital. Interventions: Patients were given 5ALA orally approximately 3 hours before surgery and underwent observation of the uterine cavity and endometrial biopsy using 5ALA-PDD during hysteroscopic resection. Specimens were diagnosed histopathologically and the diagnostic sensitivity and specificity of hysteroscopic 5ALA-PDD for malignancy in the uterine cavity was determined. Red (R), blue (B), and green (G) intensity values were determined from PDD images, and the relationships of histopathological diagnosis with these values were used to develop a model for objective diagnosis of uterine malignancy. Measurements and Main Results: Three patients were excluded from the study because of failure of the endoscope system. A total of 113 specimens were collected endoscopically. The sensitivity and specificity of 5ALA-PDD for diagnosis of malignancy in the uterine cavity were 93.8% and 51.9%, respectively. The R/B ratio in imaging analysis was highest in malignant lesions, followed by benign lesions and normal uterine tissue, with significant differences among these groups (p <.05). The R/B and G/B ratios were used in a formula for prediction of malignancy based on logistic regression and the area under the receiver operating characteristic curve for this formula was 0.838. At a formula cutoff value of 0.220, the sensitivity and specificity for diagnosis of malignant disease were 90.6% and 65.4%, respectively. Conclusion: To our knowledge, this is the first study of the diagnostic accuracy of 5ALA-PDD for malignancies in the uterine cavity. Hysteroscopic 5ALA-PDD had higher sensitivity and identifiability of lesions. These findings suggest that hysteroscopic 5ALA-PDD may be useful for diagnosis of minute lesions.
AB - Study Objective: To examine the diagnostic accuracy of hysteroscopic photodynamic diagnosis (PDD) using 5-aminolevulinic acid (5ALA) in patients with endometrial cancer and premalignant atypical endometrial hyperplasia. Design: A single-center, open-label, exploratory intervention study. Setting: University Hospital in Japan. Patients: Thirty-four patients who underwent hysteroscopic resection in the Department of Obstetrics and Gynecology at Keio University Hospital. Interventions: Patients were given 5ALA orally approximately 3 hours before surgery and underwent observation of the uterine cavity and endometrial biopsy using 5ALA-PDD during hysteroscopic resection. Specimens were diagnosed histopathologically and the diagnostic sensitivity and specificity of hysteroscopic 5ALA-PDD for malignancy in the uterine cavity was determined. Red (R), blue (B), and green (G) intensity values were determined from PDD images, and the relationships of histopathological diagnosis with these values were used to develop a model for objective diagnosis of uterine malignancy. Measurements and Main Results: Three patients were excluded from the study because of failure of the endoscope system. A total of 113 specimens were collected endoscopically. The sensitivity and specificity of 5ALA-PDD for diagnosis of malignancy in the uterine cavity were 93.8% and 51.9%, respectively. The R/B ratio in imaging analysis was highest in malignant lesions, followed by benign lesions and normal uterine tissue, with significant differences among these groups (p <.05). The R/B and G/B ratios were used in a formula for prediction of malignancy based on logistic regression and the area under the receiver operating characteristic curve for this formula was 0.838. At a formula cutoff value of 0.220, the sensitivity and specificity for diagnosis of malignant disease were 90.6% and 65.4%, respectively. Conclusion: To our knowledge, this is the first study of the diagnostic accuracy of 5ALA-PDD for malignancies in the uterine cavity. Hysteroscopic 5ALA-PDD had higher sensitivity and identifiability of lesions. These findings suggest that hysteroscopic 5ALA-PDD may be useful for diagnosis of minute lesions.
KW - 5-Aminolevulinic acid
KW - Atypical endometrial hyperplasia
KW - Endometrial cancer
KW - Hysteroscopy
KW - Photodynamic diagnosis
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U2 - 10.1016/j.jmig.2019.08.012
DO - 10.1016/j.jmig.2019.08.012
M3 - Article
C2 - 31415818
AN - SCOPUS:85072177569
SN - 1553-4650
VL - 27
SP - 1087
EP - 1094
JO - Journal of Minimally Invasive Gynecology
JF - Journal of Minimally Invasive Gynecology
IS - 5
ER -
