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| ID | Type | Description | Link |
|---|---|---|---|
| KAEK-11/26.11.2025.448 | Other Identifier | Basaksehir Cam and Sakura City Hospital Ethics Committee |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sentinel Lymph Node Mapping with ICG | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel Lymph Node Mapping | Procedure | Intraoperative sentinel lymph node mapping using indocyanine green (ICG) injected into the infundibulopelvic ligament and cervix to identify sentinel lymph nodes. |
| Measure | Description | Time Frame |
|---|---|---|
| Detection rate of sentinel lymph nodes | The proportion of patients in whom at least one sentinel lymph node is successfully identified using indocyanine green during surgery. | Intraoperative period |
| Measure | Description | Time Frame |
|---|---|---|
| Bilateral detection rate of sentinel lymph nodes | The proportion of patients in whom sentinel lymph nodes are identified bilaterally. | Intraoperative period |
| Number of sentinel lymph nodes identified |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suleyman Tunc, MD | Contact | +902129096000 | stunc4668@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Suleyman Tunc, MD | Basaksehir Camm and Sakura City Hospital | Principal Investigator |
| Ilkbal Temel Yuksel, MD | Basaksehir Camm and Sakura City Hospital | Study Chair |
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Individual participant data (IPD) will not be shared due to patient confidentiality and institutional data protection policies. De-identified data may be available from the corresponding author upon reasonable request.
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| ID | Term |
|---|---|
| D000077216 | Carcinoma, Ovarian Epithelial |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D007208 | Indocyanine Green |
| ID | Term |
|---|---|
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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Single-arm prospective study evaluating sentinel lymph node mapping using indocyanine green in early-stage epithelial ovarian cancer.
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| Indocyanine Green | Drug | Indocyanine green dye used for sentinel lymph node mapping. |
|
The number of sentinel lymph nodes detected per patient during surgery.
| Intraoperative period |
| Intraoperative and postoperative complications | Evaluation of complications related to sentinel lymph node mapping and surgery. | Up to 30 days postoperatively |
| Distribution of sentinel lymph nodes | Anatomical distribution of detected sentinel lymph nodes. | Intraoperative period |
| D004701 |
| Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |