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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Suleyman Tunc, MD
- Numero di telefono: +902129096000
- Email: stunc4668@gmail.com
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Detection rate of sentinel lymph nodes
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Bilateral detection rate of sentinel lymph nodes
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: Intraoperative period
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Anatomical distribution of detected sentinel lymph nodes.
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Intraoperative period
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Collaboratori e investigatori
Investigatori
- Investigatore principale: Suleyman Tunc, MD, Basaksehir Camm and Sakura City Hospital
- Cattedra di studio: Ilkbal Temel Yuksel, MD, Basaksehir Camm and Sakura City Hospital
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Malattie urogenitali
- Malattie genitali
- Malattie del sistema endocrino
- Neoplasie urogenitali
- Neoplasie per sede
- Neoplasie
- Malattie urogenitali femminili
- Malattie urogenitali femminili e complicanze della gravidanza
- Neoplasie per tipo istologico
- Malattie genitali, femmina
- Neoplasie delle ghiandole endocrine
- Neoplasie, ghiandolari ed epiteliali
- Malattie ovariche
- Malattie annessiali
- Neoplasie genitali, femmina
- Disturbi gonadici
- Carcinoma
- Carcinoma, epiteliale ovarico
- Neoplasie ovariche
- Composti eterociclici
- Composti eterociclici, 2 anelli
- Composti eterociclici, anello fuso
- Indoli
- Verde indocianina
Altri numeri di identificazione dello studio
- SAK-ICG-01
- KAEK-11/26.11.2025.448 (Altro identificatore: Basaksehir Cam and Sakura City Hospital Ethics Committee)
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