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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Suleyman Tunc, MD
- Número de telefone: +902129096000
- E-mail: stunc4668@gmail.com
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Diagnóstico
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Detection rate of sentinel lymph nodes
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Bilateral detection rate of sentinel lymph nodes
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
- Cadeira de estudo: Ilkbal Temel Yuksel, MD, Basaksehir Camm and Sakura City Hospital
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças urogenitais
- Doenças Genitais
- Doenças do Sistema Endócrino
- Neoplasias urogenitais
- Neoplasias por local
- Neoplasias
- Doenças Urogenitais Femininas
- Doenças urogenitais femininas e complicações na gravidez
- Neoplasias por Tipo Histológico
- Doenças Genitais Femininas
- Neoplasias das Glândulas Endócrinas
- Neoplasias Glandulares e Epiteliais
- Doenças ovarianas
- Doenças anexiais
- Neoplasias Genitais Femininas
- Distúrbios Gonadais
- Carcinoma
- Carcinoma Epitelial Ovariano
- Neoplasias ovarianas
- Compostos heterocíclicos
- Compostos heterocíclicos, 2 anel
- Compostos heterocíclicos, anel fundido
- Indoles
- Indocianina Verde
Outros números de identificação do estudo
- SAK-ICG-01
- KAEK-11/26.11.2025.448 (Outro identificador: Basaksehir Cam and Sakura City Hospital Ethics Committee)
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