About this trial
This prospective study aims to evaluate the feasibility and diagnostic performance of sentinel lymph node (SLN) mapping using indocyanine green (ICG) in patients undergoing surgery for early-stage epithelial ovarian cancer. Ovarian cancer is the most lethal gynecologic malignancy, and although systematic pelvic and paraaortic lymphadenectomy is considered a standard component of surgical staging. Moreover, systematic lymphadenectomy is associated with increased operative time, perioperative morbidity, and long-term complications such as lymphedema, without clear evidence of therapeutic benefit.
SLN mapping has been successfully implemented in other gynecologic malignancies and may provide a less invasive alternative for lymph node assessment. In this study, patients undergoing laparotomy for adnexal masses will receive intraoperative ICG injection into the infundibulopelvic ligament on the affected side and into the cervix (at the 3 and 9 o'clock positions) following intraoperative confirmation of malignant epithelial tumor by frozen section analysis. SLN detection rates, anatomical distribution, and feasibility will be assessed. In addition, intraoperative and postoperative outcomes and potential complications related to the procedure will be evaluated.
The results of this study are expected to contribute to the current evidence regarding the role of SLN mapping in early-stage epithelial ovarian cancer and may help reduce the need for systematic lymphadenectomy and its associated morbidity.
Eligibility criteria
Qualifiers
Female patients aged 18-90 years
Patients undergoing laparotomy for unilateral or bilateral adnexal mass
Intraoperative frozen section diagnosis of malignant epithelial ovarian tumor or at least borderline epithelial tumor
Patients with bilateral adnexal masses who have undergone preoperative gastrointestinal evaluation (endoscopy/colonoscopy) with exclusion of gastrointestinal malignancies
Disqualifiers
Patients with prior lymphadenectomy
Patients with radiological or intraoperative evidence of advanced-stage ovarian cancer
Patients planned for neoadjuvant chemotherapy without primary surgery
Pregnant patients
Trial design
Treatments tested in this trial
- Sentinel Lymph Node Mapping
- Indocyanine Green