An observational study in Sentinel Lymph Node Biopsy (SLNB) and Early Stage Ovarian Tumors, sponsored by Faculty of Medicine of Tunis. Recruiting at 1 site in Tunisia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Faculty of Medicine of Tunis · Observational
the standard of care in case of early ovarian cancer (stage I or II) is a complete surgery. This surgery includes : hysterectomy (remove of the uterus), bilateral salpingo-oophorectomy (remove of the adnexa), omentectomy (remove of the epiploon), bilateral pelvic lymphadenectomy (remove of pelvic lymph nodes) and para-aortic lymphadenectomy (remove of para-aortic lymph nodes). This procedure is diagnostic, curative and prognostic surgery. In fact, it allows us provider care giver to stratify the stage of the cancer, hence we give the appropriate adjuvant therapy.
However, this surgery, especially the extended lymphadenectomy, is associated with some risks: lymphocele, vessel injury, blood loss, morbidity, long recovery period ... In order to reduce these risks, we propose a sentinel lymph node biopsy. This intervention allows us to detect first lymph node relay whether pelvic or para-aortic.
In our study, we chose the patent blue dye as a tracer. This tracer is widely used in oncologic surgery (for example in breast cancer) and approved but not in ovarian cancer yet.
During surgery for early stage ovarian cancer, we will inject the patent blue dye on both side of the ovarian tumor. Then, we will check for first colorful lymph node, in both pelvic and para-aortic regions. We will send these dissected lymph node to pathology for analysis. Finally, we will continue the procedure as the standard of care.
Our objective is to compare the results between the sentinel lymph node and the complete lymphadenectomy and to study the technique of sentinel lymph node biopsy using the blue patent dye as tracer.
Patients, with an early-stage ovarian cancer ESOC (FIGO stage I \& II), will be recruited. In our setting, the preoperative staging is based on :
These patients will receive a complete surgery for ovarian cancer : Peritoneal cytology, Bilateral adnexectomy, hysterectomy, pelvic lymphadenectomy, paraaortic lymphadenectomy, omentectomy and peritoneal biopsies.
Prior to the adnexectomy, surgeon will inject in subperitoneal space of the infundibular ligament (1 ml of patent blue dye: 0.5 ml in ventral and 0.5 ml in dorsal) and of the utero-ovarian ligament (1 ml of patent blue dye: 0.5 ml in ventral and 0.5 ml in dorsal). Then we will wait for 15 minutes: during which we will proceed to the adnexectomy. After 15 min, the retroperitoneal space of the pelvic and para-aortic regions was opened, and the presence of Sentinelle lymph Nodes (SLNs) was examined visually. The surgeon will record the number and location of the resected SLNs. Following the identification and removal of the SLNs, a complete systematic bilateral pelvic and para-aortic lymphadenectomy is performed. All specimen will be subject to histology analysis.
The collected data:
PreOperative informations:
Peri-operative data:
Pathological finding:
Post-operative follow-up
Faculty of Medicine of Tunis is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
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Patient suspected with a FIGO Stage I or II ovarain cancer ( Based on MRI and scanner finding). Patients with planned for surgical complete stadification including pelvic and para-aortic lymphadenectomy.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with preoperative diagnosis (Using abdominal MRI and thoraco-abdomino-pelvic scan) of early stage ovarian cancer (FIGO stage I \& II ). Paitients with O-RADs 4 or 5 MRI ovarian tumors with or without elevated ovarian tumor markers.
Procedure: Sentinel node biopsy with patent blue dye
Sentinel lymph node using patent blue dye for early ovarian cancer
Also known as: sentinel lymph node biopsy using patent blue dye for early stage ovarian cancer
Technical feasibility
Overall SLN Detection Rate: This is defined as the proportion of patients in whom at least one SLN is identified (either pelvic or para-aortic) using the blue tracer
Time frame: From the procedure to the pathology results at 4 weeks
Negative predictive value
representing the probability that a negative SLN truly indicates that all other nodes in that drainage basin are free of disease
Time frame: From the procedure till the results of pathology at 4 weeks
Sensitivity
The proportion of patients with node-positive disease correctly identified by the SLN technique
Time frame: From the procedure till the results of pathology at 4 weeks
Anatomical Distribution
Analysis of where the SLNs are located
Time frame: During the procedure
Plan to share: No — The only data that i will share is specified in study description: PreOperative informations: Sociodemographic data : Age, Body Mass Index, Menopausal status.. History: Family history of cancer, Comorbidity, surgical history.. Ovarian tumor biomarkers PreOperative imaging: MRI, CT scan, Ultrasonography Presumed FIGO stage (I or II) Peri-operative data: SLN procedure: injection timing, Injected volume and site, Time to visual detection, site and number of detection Operative complications: vessel injury, nerve injury and allergic reaction to dye Pathological finding: tumor characterization: type (serous, mucinous,...), grade and tumor size SLN analysis: SLN frozen section, SLN final ultrastaging Non-SLN status after complete lymphadenectomy Final FIGO stage Post-operative follow-up Hospital stay duration Post-operative complications (within Clavien-Dindo) adjuvant therapy
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Faculty of Medicine of Tunis