Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with preoperative diagnosis of early stage ovarian cancer (FIGO stage I & II ) | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sentinel node biopsy with patent blue dye | Procedure | Sentinel lymph node using patent blue dye for early ovarian cancer |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From the procedure to the pathology results at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Negative predictive value | representing the probability that a negative SLN truly indicates that all other nodes in that drainage basin are free of disease | From the procedure till the results of pathology at 4 weeks |
| Sensitivity |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohammed Amine Hannachi, Assistant professor | Contact | +21699696332 | +216 | medaminehannachi3@gmail.com |
| Khaled Neji, Professor | Contact | +21651352742 | +216 | DRKHALEDNEJI21@GMAIL.COM |
| Name | Affiliation | Role |
|---|---|---|
| KHALED NEJI, Professor | Maternity and neonatology center of Tunis | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maternity and neonatology center of Tunis | Recruiting | La Rabta | 1007 | Tunisia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36408149 | Background | 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. | |
| 34552868 | Background | 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. |
Not provided
Not provided
The only data that i will share is specified in study description:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
The proportion of patients with node-positive disease correctly identified by the SLN technique
| From the procedure till the results of pathology at 4 weeks |
| Anatomical Distribution | Analysis of where the SLNs are located | During the procedure |
| 39511679 | Background | 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. |
| 38006759 | Background | 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.ejca.2023.113435. Epub 2023 Nov 14. |
| 38435483 | Background | 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. |
| 35470254 | Background | 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. |
| 34645514 | Background | 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. |
| 37487662 | Background | 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. |
| 39952605 | Background | Valenzuela-Mendez B, Bentivegna E, Bats AS, Azais H. Robotic Sentinel Lymph Node Dissection for Presumed Early-Stage Epithelial Ovarian Cancer Stadification by Transperitoneal and Retroperitoneal Approaches. J Minim Invasive Gynecol. 2025 Apr;32(4):316-317. doi: 10.1016/j.jmig.2024.12.017. Epub 2025 Feb 12. |
| 34562642 | Background | Van NT, Nguyen-Xuan HT, Koual M, Bentivegna E, Bats AS, Azais H. [Sentinel lymph node biopsy in the management of early-stage ovarian cancer: A systematic review of the literature]. Gynecol Obstet Fertil Senol. 2022 Jan;50(1):75-81. doi: 10.1016/j.gofs.2021.09.011. Epub 2021 Sep 22. French. |
| 37980769 | Background | Agusti N, Vidal-Sicart S, Paredes P, Celada-Castro C, Migliorelli F, Glickman A, Marina T, Fuste P, Carreras-Dieguez N, Saco A, Diaz-Feijoo B, Torne A. Mapping sentinel lymph nodes in early-stage ovarian cancer (MELISA) trial - a further step towards lymphadenectomy replacement. Gynecol Oncol. 2023 Dec;179:145-151. doi: 10.1016/j.ygyno.2023.11.007. Epub 2023 Nov 18. |
| 39206992 | Background | Zhu M, Li J, Lu L, Duan J, Jiang W. Lymph node metastasis in grossly apparent early-stage epithelial ovarian cancer: A retrospective clinical study at a tertiary institute. J Cancer Res Ther. 2024 Aug 1;20(4):1300-1305. doi: 10.4103/jcrt.jcrt_2489_23. Epub 2024 Aug 29. |
| 39414311 | Background | Rey I, Lago V, Arnaez M, Bizzarri N, Agusti N, Nero C, Diaz-Feijoo B, Padilla-Iserte P, Domingo S. Key issues in diagnostic accuracy of sentinel lymph node biopsy in early-stage ovarian cancer: systematic review and meta-analysis. Int J Gynecol Cancer. 2024 Nov 4;34(11):1787-1794. doi: 10.1136/ijgc-2024-005970. |
| 36108452 | Background | Rodrigues Teixeira F, Vertematti de Castro V, Chaves Faloppa C, Mantoan H, Yuri Kumagai L, Narcizo Oliveira Menezes A, Badiglian-Filho L, De Brot L, Tirapelli Goncalves B, Paiva Gadelha Guimaraes A, Baiocchi G. Impact of lymph node staging in presumed early-stage ovarian carcinoma. Eur J Obstet Gynecol Reprod Biol. 2022 Nov;278:6-10. doi: 10.1016/j.ejogrb.2022.08.027. Epub 2022 Sep 7. |
| 39016276 | Background | Bizzarri N, Nero C, Di Berardino S, Scambia G, Fagotti A. Future of sentinel node biopsy in ovarian cancer. Curr Opin Oncol. 2024 Sep 1;36(5):412-417. doi: 10.1097/CCO.0000000000001058. Epub 2024 Jul 16. |
| 37892029 | Background | Zachou G, Yongue G, Chandrasekaran D. Feasibility of Sentinel Lymph Node Biopsy in Early-Stage Epithelial Ovarian Cancer: A Systematic Review and Meta-Analysis. Diagnostics (Basel). 2023 Oct 14;13(20):3209. doi: 10.3390/diagnostics13203209. |
| 37821093 | Background | Seon KE, Kim SW, Kim YT. Clinical relevance of sentinel lymph node biopsy in early ovarian cancer. Obstet Gynecol Sci. 2023 Nov;66(6):498-508. doi: 10.5468/ogs.23114. Epub 2023 Oct 11. |
| 37945057 | Background | Lago V, Arnaez M, Padilla-Iserte P, Guijarro-Campillo AR, Matute L, Gurrea M, Bello P, Domingo S. Alternatives of the pelvic sentinel lymph node migration pathway in early ovarian cancer: the simplest the best. Int J Gynecol Cancer. 2024 Apr 1;34(4):639-640. doi: 10.1136/ijgc-2023-004912. No abstract available. |
| 36974675 | Background | Wang J, Chen S, Zhong F, Zhu T, Zhao Y. A LASSO-derived prediction model for assessing the risk of lymph node metastasis in T1 and T2 epithelial ovarian cancer: an international retrospective cohort study. Int J Surg. 2023 Mar 27. doi: 10.1097/JS9.0000000000000065. Online ahead of print. |
| ID | Term |
|---|---|
| D021701 | Sentinel Lymph Node Biopsy |
| ID | Term |
|---|---|
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D008197 | Lymph Node Excision |
| D008919 | Investigative Techniques |
Not provided
Not provided