Patent Blue SLN in Early Ovarian Cancer Prospective Study (FIGO I-II) Evaluating Patent Blue SLN Mapping. Injection Into IP/UO Ligaments in Situ. Goals: Assess Feasibility and Accuracy vs Standard Lymphadenectomy to Minimize Surgical Morbidity

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorFaculty of Medicine of Tunis

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age : aged 18 years-old or older

Diagnosis: Suspected Ovarian cancer on MRI finding (O-RADs 4 or 5)

FIGO stage: Stage I or II ( Based on MRI and scanner finding)

Planned Procedure: Patients with planned for surgical complete stadification including pelvic and para-aortic lymphadenectomy

Disqualifiers

Suspicious nodal involvement: Presence of suspicious lymph nodes on preoperative imaging (generally defined by a short-axis diameter ≥ 10 mm).

Disease extension: Radiological or intraoperative evidence of extra-pelvic metastases or peritoneal carcinomatosis.

Surgical history: History of lymphadenectomy, lymph node sampling, or major vascular surgery involving the aorta or the iliac vessels.

History of radiotherapy: Patients who have previously undergone pelvic or abdominal radiotherapy.

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Sentinel node biopsy with patent blue dye

    Procedure/Surgery

    Sentinel lymph node using patent blue dye for early ovarian cancer

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: Patients with preoperative diagnosis of early stage ovarian cancer (FIGO stage I & II )1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

Anatomical Distribution

Analysis of where the SLNs are located

Time frame
During the procedure

Other outcomes

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