Clinical trial · Interventional
Sentinel Lymph Node Mapping in Early-Stage Epithelial Ovarian Cancer Surgery
Feasibility and Evaluation of Sentinel Lymph Node Mapping in Early-Stage Epithelial Ovarian Cancer Surgery: A Tertiary Center Prospective Cohort Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Epithelial Ovarian Cancer | Ovarian Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine Green | Drug | — | UNRESOLVED |
| Sentinel Lymph Node Mapping | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sentinel Lymph Node Mapping with ICG
- description
- Patients undergoing surgery for suspected early-stage epithelial ovarian cancer will receive intraoperative sentinel lymph node mapping using indocyanine green injected into the infundibulopelvic ligament and cervix.
- interventionNames
- Procedure: Sentinel Lymph Node Mapping
- Drug: Indocyanine Green
Primary outcomes (1)
- measure
- Detection rate of sentinel lymph nodes
- timeFrame
- Intraoperative period
- description
- The proportion of patients in whom at least one sentinel lymph node is successfully identified using indocyanine green during surgery.
Secondary outcomes (4)
- measure
- Bilateral detection rate of sentinel lymph nodes
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Patients without radiological evidence of advanced-stage ovarian cancer on preoperative imaging (PET, MRI, or CT), including absence of pleural effusion, omental cake, peritoneal carcinomatosis, malignant ascites, liver or splenic parenchymal involvement, and mesenteric involvement * Patients who provide written informed consent Exclusion Criteria: * 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 * Patients with known allergy to indocyanine green (ICG) or iodine * Patients with immunodeficiency disorders * Patients with a history of radiotherapy * Patients with a history of vascular surgery affecting lymphatic drainage * Patients with a history of vascular surgery affecting lymphatic drainage * Patients with a history of non-gynecological malignancy * Patients younger than 18 years or older than 90 years
References
Publications (0)
Data not yet available