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NOT YET RECRUITING
NCT07593339
NA

Sentinel Lymph Node Mapping in Early-Stage Epithelial Ovarian Cancer Surgery

Sponsor: Başakşehir Çam & Sakura City Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Feasibility and Evaluation of Sentinel Lymph Node Mapping in Early-Stage Epithelial Ovarian Cancer Surgery: A Tertiary Center Prospective Cohort Study

Key Details

Gender

FEMALE

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-06-01

Completion Date

2028-03-01

Last Updated

2026-05-18

Healthy Volunteers

No

Interventions

PROCEDURE

Sentinel Lymph Node Mapping

Intraoperative sentinel lymph node mapping using indocyanine green (ICG) injected into the infundibulopelvic ligament and cervix to identify sentinel lymph nodes.

DRUG

Indocyanine Green

Indocyanine green dye used for sentinel lymph node mapping.