Maternity and neonatology center of Tunis
La Rabta, 1007, Tunisia
Location status: Recruiting
Location contact
Hannachi Amine
CONTACT
Hannachi M Mohammed Amine, Assistant Professor
PRINCIPAL_INVESTIGATOR
CONTACT
NCT Number: NCT07508306
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.
Interested in participating?
Request Info18 year and older
Female
Observational
La Rabta, 1007, Tunisia
Location status: Recruiting
Hannachi Amine
CONTACT
Hannachi M Mohammed Amine, Assistant Professor
PRINCIPAL_INVESTIGATOR
CONTACT
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:
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Sentinel lymph node using patent blue dye for early ovarian cancer
Other names: sentinel lymph node biopsy using patent blue dye for early stage ovarian cancer
Time frame: From the procedure to the pathology results at 4 weeks
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 till the results of pathology at 4 weeks
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
The proportion of patients with node-positive disease correctly identified by the SLN technique
Time frame: During the procedure
Analysis of where the SLNs are located
Contact information is provided by the study sponsor or research team.
Khaled Neji, Professor
CONTACT
+21651352742 ext. +216
Mohammed Amine Hannachi, Assistant professor
CONTACT
+21699696332 ext. +216
Faculty of Medicine of Tunis
Other
Evaluation of Sentinel Lymph Node Biopsy Using Patent Blue Dye in Early-Stage Ovarian Cancer: A Prospective Observational Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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