Indocyanine green and infrared fluorescence in sentinel lymph node mapping for endometrial cancer and cervical cancer: An exploratory study
- Conditions
- Endometria cancer, Cervical cancer
- Registration Number
- JPRN-jRCTs031180426
- Lead Sponsor
- sui Hirokazu
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 46
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The detection rate of S
- Secondary Outcome Measures
Name Time Method 1.The sensitivity of sentinel lymph node (SLN)<br>2 A false negative rate of SLN<br>3. Negative predictive value of SLN<br>4. The accuracy of pathological diagnosis during surgery<br>5. The number and location of the SLNs<br>6. Adverse effects