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
This trial does not accept healthy volunteersQualifiers
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
Single group
Treatments tested in this trial
Sentinel Lymph Node Mapping
Procedure/SurgeryIntraoperative sentinel lymph node mapping using indocyanine green (ICG) injected into the infundibulopelvic ligament and cervix to identify sentinel lymph nodes.
Indocyanine Green
DrugIndocyanine green dye used for sentinel lymph node mapping.
Treatment groups
Trial outcomes
Primary outcomes
Detection rate of sentinel lymph nodes
The proportion of patients in whom at least one sentinel lymph node is successfully identified using indocyanine green during surgery.
Secondary outcomes
Bilateral detection rate of sentinel lymph nodes
The proportion of patients in whom sentinel lymph nodes are identified bilaterally.
Number of sentinel lymph nodes identified
The number of sentinel lymph nodes detected per patient during surgery.
Intraoperative and postoperative complications
Evaluation of complications related to sentinel lymph node mapping and surgery.
Distribution of sentinel lymph nodes
Anatomical distribution of detected sentinel lymph nodes.
Locations
Sponsors and contacts
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