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Lago Leal, Víctor
Domingo Del Pozo, Santiago (dir.) Departament de Pediatria, Obstetrícia i Ginecologia |
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Aquest document és un/a tesi, creat/da en: 2020 | |
Introduction: Apparent early stage ovarian cancer could represent an ideal disease scenario for the application of the technique of sentinel node. However, the published experience is limited. Our goal was to evaluate the feasibility and safety of the sentinel lymph node technique in patients with clinical stage FIGO I-II ovarian cancer.
Methods: We conducted a prospective pilot study including 10 patients and a clinical trial including 20 patients with confirmed ovarian cancer histology. As tracers 99mTc and indocyanine green (ICG) were used and injected both into the uterus-ovary and infundibulopelvic ligament stump. By using a gamma probe and an near-infrared vision device for fluorescence imaging SLN were detected. The inclusion criteria were: > 18 years of age, suspicious adnexal mass (unilateral or bilateral) in ultrasound and CT scan or confirmed ovarian tumor in a previous sur...
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Introduction: Apparent early stage ovarian cancer could represent an ideal disease scenario for the application of the technique of sentinel node. However, the published experience is limited. Our goal was to evaluate the feasibility and safety of the sentinel lymph node technique in patients with clinical stage FIGO I-II ovarian cancer.
Methods: We conducted a prospective pilot study including 10 patients and a clinical trial including 20 patients with confirmed ovarian cancer histology. As tracers 99mTc and indocyanine green (ICG) were used and injected both into the uterus-ovary and infundibulopelvic ligament stump. By using a gamma probe and an near-infrared vision device for fluorescence imaging SLN were detected. The inclusion criteria were: > 18 years of age, suspicious adnexal mass (unilateral or bilateral) in ultrasound and CT scan or confirmed ovarian tumor in a previous surgery (unilateral or bilateral salpingo-oophorectomy with or without hysterectomy). Adverse events were recorded intra-operatively, at discharge, and at postoperative day 30 (+/- 1 week). The primary objective was to report adverse events related to the technique, including the 99mTc and ICG intra-peritoneal injection, as well as the feasibility of carrying out the technique.
Results: After the positive results of the pilot study, with a detection rate in the pelvic region of 87.5% (7/8) and 70% (7/10) in the para-aortic field, a clinical trial was carried out with a total of 20 patients. In this group, sentinel nodes were detected in 14/15 (93%) in the pelvic field and 20/20 (100%) in the para-aortic area. The mean time from injection to sentinel lymph node resection was 53 ± 15 min (range; 30-80). The mean number of harvested sentinel nodes was 2.2 ± 1.5 (range; 0-5) lymph nodes in the pelvis and 3.3 ± 1.8 (range; 1-7) para-aortic. There were neither intra-operative technique-related adverse events nor within 30 days of t follow-up.
Conclusion: This research shows the viability of the SLN technique protocol in early stage ovarian cancer with a detection rate close to 100% in the clinical trial (NCT03452982) without associating major safety problems.Objetivo: el cáncer de ovario en estadio inicial podría representar una escenario de enfermedad ideal para la aplicación de la técnica de
ganglio centinela. Sin embargo, la experiencia publicada es limitada. Nuestro objetivo es evaluar la viabilidad y la seguridad de la biopsia
selectiva de ganglio centinela en pacientes con cáncer de ovario en estadio clínico I # II.
Métodos: Realizamos un estudio piloto prospectivo con 10 pacientes y un ensayo clínico con 20 pacientes con cáncer de ovario confirmado
histológicamente. Como trazadores usamos 99mTc y verde de indocianina que se inyectaron tanto en el útero-ovario y muñón del ligamento
infundibulopélvico. Mediante una gamma sonda y un dispositivo de vision de luz infraroja para toma de imágenes de fluorescencia se
detectaron los ganglios linfáticos centinela. Criterios de inclusión:> 18 años de edad, masa anexial sospechosa (unilateral o bilateral) en
ecografía y tomografía computarizada o tumor ovárico confirmado después de una cirugía previa (unilateral o salpingooforectomía bilateral
con o sin histerectomía). Los eventos adversos se registraron intraoperatoriamente, al alta y en el día postoperatorio 30 (+/- 1 semana). El
objetivo primario fue informar eventos adversos relacionados con la técnica, incluyendo el uso de 99mTc e ICG por vía intraperitoneal, así
como el viabilidad de realización de la técnica.
Resultados: Tras los resultados positivos del estudio piloto, con una tasa de detección en la región pélvica del 87,5% (7/8) y en la región
paraaórtica
del 70% (7/10) se realizo el ensayo clínico con un total de 20 pacientes. En este grupo, los ganglios centinela se detectaron en 14/15
(93%) en territorio pélvico y 20/20 (100%) en el para-aórtico. El tiempo medio desde la inyección hasta
la resección de los ganglios linfáticos centinela fue de 53 ± 15 min (rango; 30-80). El número medio de ganglios centinela resecados Fue
de 2.2 ± 1.5 (rango; 0-5) ganglios linfáticos en la pelvis y 3.3 ± 1.8 (rango; 1-7) para-aórticos. No hubo eventos intraoperatorios adversos, ni
ninguno dentro de los 30 días de seguimiento relacionado con la técnica.
Conclusión: Hemos demostrado la viabilidad del protocolo de ganglio centinela en cáncer de ovario en estadio inicial con una tasa de
detección cercana al 100% en el ensayo clínico (NCT03452982) sin que asocie problemas mayores de seguridad.
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