臨床研究等提出・公開システム

Indocyanine green and infrared fluorescence in sentinel lymph node mapping for endometrial cancer and cervical cancer: An exploratory study

Indocyanine green and infrared fluorescence in sentinel lymph node mapping for endometrial cancer and cervical cancer: An exploratory study

46

Total (N = 46) Median age: 50.0 years (range 30~70) Endometrial cancer/ cervical cancer: 23/23 Lymph node swelling detected by preoperative CT scanning, yes/no: 3/43 Endometrial cancer (N = 23) Median age: 59.0 years (range 38~70) Lymph node swelling detected by preoperative CT scanning, yes/no: 3/20 Median level of CA125: 17.40 U/mL (range 5.6~244.6 U/mL) Cervical cancer (N = 23) Median age: 45.0 years (range 30~61) Clinical stage: stage 1A; 10 cases, 1A2; 2 cases, 1B1; 19 cases, 1B2; 2 cases Lymph node swelling detected by preoperative CT scanning, yes/no: 0/23 Median tumor size in diameter: 1.90 cm (range 0.3~4.2 cm)

The study was terminated before the targeted initial sample size (n=90) because of the exhaustion of research funds. Between November 8, 2016, and January 26, 2021, the patients signed the informed consent form. Recruitment: 49 Completion: 46 Cancellation: 3 The reasons for the cancellation: 1) Unable to determine the sentinel lymph node mapping due to the leakage of ICG into intraperitoneal cavity. 2) Unable to inject ICG to the small cervix of uterus after conization. 3) Unable to inject ICG because of the breakdown of detection equipment.

No adverse events were observed.

Primary outcome: The detection rates of sentinel lymph nodes (the cases with the sentinel lymph node(s) confirmed pathologically/ the completed cases) and the 95% confidence intervals in total, endometrial cancer and cervical cancer were 80.4% [66.1, 90.6], 69.6% [47.1, 86.8] and 91.3% [72.0, 98.9]. Secondary outcome: 1. Sensitivity of sentinel lymph The sensitivities of sentinel lymph node in total, endometrial cancer and cervical cancer were 100% (3/3), 100% (1/1) and 100% (2/2). 2. False negative rate The false negative rates of sentinel lymph node in total, endometrial cancer and cervical cancer were 0% (0/3), 0% (0/1) and 0% (0/2). 3. Negative predictive value The negative predictive values in total, endometrial cancer and cervical cancer were 100% (43/43),100% (22/22) and 100% (21/21). 4. Detection number and sites of sentinel lymph nodes In total, 94 sentinel lymph nodes were determined (endometrial cancer; 43, cervical cancer; 51). The sites of sentinel lymph nodes in endometrial cancer were right external iliac (20), left external iliac (11), right obturator (3), left obturator (6), and right common iliac (3). The sites of sentinel lymph nodes in cervical cancer were right external iliac (25), left external iliac (19), right obturator (7), left obturator (7), suprainguinal node (1), and left internal iliac (2). 5. Incidence of adverse events There was no adverse event.

The study was terminated before the targeted initial sample size. The detection rate of sentinel lymph nodes in this study was about 80.4% and 95%CI. The negative predictive value was 100%. There was no adverse event according to the injection of ICG. Although the number of cases was small, the negative predictive value was 100%, suggesting that lymph node dissection may be omitted in cases with negative sentinel lymph nodes.

Mar. 31, 2023

No

We did not plan IPD in the present trial.

https://jrct.niph.go.jp/latest-detail/jRCTs031180426

Usui Hirokazu

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba, Japan

hirokazu-usui@faculty.chiba-u.jp

Usui Hirokazu

Chiba University Hospital

1-8-1 Inohana, Chuo-ku, Chiba, Japan

260-8677

hirokazu-usui@faculty.chiba-u.jp

Complete

Nov. 01, 2016

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

1. Patients with endometrial cancer who are scheduled for retroperitoneal lymph node dissection or patients with stage 1A2 to 2A1 cervical cancer based on the International Federation of Gynecology and Obstetrics guidelines.
2. Over 20 years of age and under 70 years of age
3. Eastern Cooperative Oncology Group Performance status score 0-1
4. Patients who provide written informed consent

1. Prior medical history of chemical sensitivity to indocyanine green
2. Detection of obvious lymph node swelling using CT or MRI
3. Extra-uterine dissemination
4. Patients on dialysis
5. Patients determine to be ineligible for any other reason by the physician in-charge

Female

Endometria cancer, Cervical cancer

The concentration of indocyanine green (ICG) is 2.5 mg/mL. For each patient, a 25 mg vial with ICG powder is diluted in 10 mL of sterile water. We routinely inject 4 mL of the ICG solution into the cervix divided in the 3 - and 9-o'clock positions, 1 mL deep into the stroma and 1 mL submucosally on the right and the left of the cervix. Additionally, in patients with endometrial cancer, 2 mL of ICG is injected into the myometrium divided into the lower uterine segment and uterine fundus (midline subserosa). A near-infrared fluorescence imaging system Photodynamic Eye (PDE - Neo, Hamamatsu Photonics, Hamamatsu, Japan) is used to detect the SNLs.

106

The detection rate of SLN

1.The sensitivity of sentinel lymph node (SLN)
2 A false negative rate of SLN
3. Negative predictive value of SLN
4. The accuracy of pathological diagnosis during surgery
5. The number and location of the SLNs
6. Adverse effects

+81-43-226-2616

Feb. 20, 2019

none