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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-90
SponsorBaşakşehir Çam & Sakura City Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Sentinel Lymph Node Mapping

    Procedure/Surgery

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

  • Indocyanine Green

    Drug

    Indocyanine green dye used for sentinel lymph node mapping.

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Sentinel Lymph Node Mapping with ICGExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

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.

Time frame
Intraoperative period

Secondary outcomes

1

Bilateral detection rate of sentinel lymph nodes

The proportion of patients in whom sentinel lymph nodes are identified bilaterally.

Time frame
Intraoperative period
2

Number of sentinel lymph nodes identified

The number of sentinel lymph nodes detected per patient during surgery.

Time frame
Intraoperative period
3

Intraoperative and postoperative complications

Evaluation of complications related to sentinel lymph node mapping and surgery.

Time frame
Up to 30 days postoperatively
4

Distribution of sentinel lymph nodes

Anatomical distribution of detected sentinel lymph nodes.

Time frame
Intraoperative period

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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