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
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Epithelial ovarian cancer is the most lethal gynecologic malignancy, and accurate surgical staging plays a critical role in determining prognosis and guiding adjuvant treatment. Although systematic pelvic and paraaortic lymphadenectomy is considered a standard component of staging surgery in early-stage disease, the incidence of lymph node metastasis remains relatively low, and the procedure is associated with increased operative time and morbidity, including lymphedema and surgical complications.
Sentinel lymph node (SLN) mapping has been successfully adopted in other gynecologic cancers as a less invasive alternative for lymph node assessment. However, its role in early-stage epithelial ovarian cancer remains under investigation. This study is designed as a prospective cohort study conducted at a tertiary referral center.
Patients undergoing laparotomy for unilateral or bilateral adnexal masses will be included. Following intraoperative frozen section confirmation of malignant epithelial ovarian tumor, indocyanine green (ICG) will be injected into the infundibulopelvic ligament on the affected side and into the cervix at the 3 and 9 o'clock positions. Sentinel lymph nodes will be identified and evaluated.
The primary objective of the study is to assess the feasibility and detection rate of SLN mapping. Secondary objectives include evaluation of anatomical distribution of SLNs, intraoperative findings, perioperative outcomes, and potential complications.
The findings of this study are expected to contribute to the existing literature and may support the use of SLN mapping as an alternative to systematic lymphadenectomy in selected patients with early-stage epithelial ovarian cancer.
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Suleyman Tunc, MD
- Número de teléfono: +902129096000
- Correo electrónico: stunc4668@gmail.com
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Diagnóstico
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: Sentinel Lymph Node Mapping with ICG
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.
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Intraoperative sentinel lymph node mapping using indocyanine green (ICG) injected into the infundibulopelvic ligament and cervix to identify sentinel lymph nodes.
Indocyanine green dye used for sentinel lymph node mapping.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Detection rate of sentinel lymph nodes
Periodo de tiempo: Intraoperative period
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The proportion of patients in whom at least one sentinel lymph node is successfully identified using indocyanine green during surgery.
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Intraoperative period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Bilateral detection rate of sentinel lymph nodes
Periodo de tiempo: Intraoperative period
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The proportion of patients in whom sentinel lymph nodes are identified bilaterally.
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Intraoperative period
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Number of sentinel lymph nodes identified
Periodo de tiempo: Intraoperative period
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The number of sentinel lymph nodes detected per patient during surgery.
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Intraoperative period
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Intraoperative and postoperative complications
Periodo de tiempo: Up to 30 days postoperatively
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Evaluation of complications related to sentinel lymph node mapping and surgery.
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Up to 30 days postoperatively
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Distribution of sentinel lymph nodes
Periodo de tiempo: Intraoperative period
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Anatomical distribution of detected sentinel lymph nodes.
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Intraoperative period
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Suleyman Tunc, MD, Basaksehir Camm and Sakura City Hospital
- Silla de estudio: Ilkbal Temel Yuksel, MD, Basaksehir Camm and Sakura City Hospital
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Enfermedades del sistema endocrino
- Neoplasias urogenitales
- Neoplasias por sitio
- Neoplasias
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Neoplasias por tipo histológico
- Enfermedades Genitales Femeninas
- Neoplasias de glándulas endocrinas
- Neoplasias Glandulares y Epiteliales
- Enfermedades Ováricas
- Enfermedades anexiales
- Neoplasias Genitales Femeninas
- Trastornos gonadales
- Carcinoma
- Carcinoma Epitelial De Ovario
- Neoplasias Ováricas
- Compuestos heterocíclicos
- Compuestos heterocíclicos, 2 anillos
- Compuestos heterocíclicos, anillo fusionado
- Indoles
- Verde de indocianina
Otros números de identificación del estudio
- SAK-ICG-01
- KAEK-11/26.11.2025.448 (Otro identificador: Basaksehir Cam and Sakura City Hospital Ethics Committee)
Plan de datos de participantes individuales (IPD)
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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