Condition: Sentinel Lymph Node Biopsy (SLNB) · Early Stage Ovarian Tumors · Sponsor: Faculty of Medicine of Tunis
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 …
This description comes directly from the study's public registry record.
Mohammed Amine Hannachi, Assistant professor · +21699696332 · medaminehannachi3@gmail.com
Khaled Neji, Professor · +21651352742 · DRKHALEDNEJI21@GMAIL.COM
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| Maternity and neonatology center of Tunis | La Rabta, Tunisia | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07508306