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

Официальное название

Evaluation of Sentinel Lymph Node Biopsy Using Patent Blue Dye in Early-Stage Ovarian Cancer: A Prospective Observational Study

Обзор

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.

Подробное описание

Patients, with an early-stage ovarian cancer ESOC (FIGO stage I \& II), will be recruited. In our setting, the preoperative staging is based on :

* MRI finding (O-RADs classification 4 OR 5) * Thoraco-abdominal CT scan * Gastrointestinal endoscopy (if needed) * Ovarian tumor biomarkers (CA 125, CA 19-9, Alpha-FP, HE4...) Or patients referred to our department for management of an ESOC with after an adnexectomy for ovarian mass.

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:

1. 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) 2. 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 3. 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 4. Post-operative follow-up

* Hospital stay duration * Post-operative complications (within Clavien-Dindo classification) * Adjuvant therapy

Вмешательства

• Процедура Sentinel node biopsy with patent blue dye
  Sentinel lymph node using patent blue dye for early ovarian cancer

Первичные конечные точки

• Technical feasibility [Срок оценки: From the procedure to the pathology results at 4 weeks]

Вторичные конечные точки (3)

• Negative predictive value [Срок оценки: From the procedure till the results of pathology at 4 weeks]
• Sensitivity [Срок оценки: From the procedure till the results of pathology at 4 weeks]
• Anatomical Distribution [Срок оценки: During the procedure]

Критерии участия

Критерии включения

• 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
• Consent: Signing of the written informed consent after full information has been provided

Критерии исключения

• 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.
• Allergies: Known allergy or adverse reaction to patent blue dyes.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Tunisia · 1 центр

• Maternity and neonatology center of Tunis — La Rabta

Публикации

• Kampan NC, Teik CK, Shafiee MN. Where are we going with sentinel nodes mapping in ovarian cancer? Front Oncol. 2022 Nov 3;12:999749. doi: 10.3389/fonc.2022.999749. eCollection 2022. PMID 36408149
• Chen J, Yin J, Li Y, Gu Y, Wang W, Shan Y, Wang YX, Qin M, Cai Y, Jin Y, Pan L. Systematic Lymph Node Dissection May Be Abolished in Patients With Apparent Early-Stage Low-Grade Mucinous and Endometrioid Epithelial Ovarian Cancer. Front Oncol. 2021 Sep 6;11:705720. doi: 10.3389/fonc.2021.705720. eCollection 2021. PMID 34552868
• Wang H, Wang S, Wang P, Han Y. Survival outcomes of lymph node dissection in early-stage epithelial ovarian cancer: identifying suitable candidates. World J Surg Oncol. 2024 Nov 7;22(1):294. doi: 10.1186/s12957-024-03571-7. PMID 39511679
• Nero C, Bizzarri N, Di Berardino S, Sillano F, Vizzielli G, Cosentino F, Vargiu V, De Iaco P, Perrone AM, Vizza E, Chiofalo B, Uccella S, Ghezzi F, Turco LC, Corrado G, Giannarelli D, Pasciuto T, Zannoni GF, Fagotti A, Scambia G. Sentinel-node biopsy in apparent early stage ovarian cancer: final results of a prospective multicentre study (SELLY). Eur J Cancer. 2024 Jan;196:113435. doi: 10.1016/j.e PMID 38006759
• Ataei Nakhaei S, Sadeghi R, Mostafavi SM, Treglia G, Hassanzadeh M, Esmaeilpour M, Taheri NS, Farazestanian M. Sentinel Node Mapping in Ovarian Tumors: A Study Using Lymphoscintigraphy and SPECT/CT. Contrast Media Mol Imaging. 2024 Feb 23;2024:5453692. doi: 10.1155/2024/5453692. eCollection 2024. PMID 38435483
• Agusti N, Paredes P, Vidal-Sicart S, Glickman A, Torne A, Diaz-Feijoo B. Sentinel lymph node mapping in early-stage ovarian cancer: surgical technique in 10 steps. Int J Gynecol Cancer. 2022 Aug 1;32(8):1082-1083. doi: 10.1136/ijgc-2022-003420. No abstract available. PMID 35470254
• Laven P, Kruitwagen R, Zusterzeel P, Slangen B, van Gorp T, van der Pol J, Lambrechts S. Sentinel lymph node identification in early stage ovarian cancer: is it still possible after prior tumor resection? J Ovarian Res. 2021 Oct 13;14(1):132. doi: 10.1186/s13048-021-00887-w. PMID 34645514
• Agusti N, Viveros-Carreno D, Grillo-Ardila C, Izquierdo N, Paredes P, Vidal-Sicart S, Torne A, Diaz-Feijoo B. Sentinel lymph node detection in early-stage ovarian cancer: a systematic review and meta-analysis. Int J Gynecol Cancer. 2023 Oct 2;33(10):1493-1501. doi: 10.1136/ijgc-2023-004572. PMID 37487662

Идентификаторы

NCT: NCT07508306 · MedSchoolTunisia

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗