BACKGROUND: This is a multicentre, European, prospective trial evaluating the diagnostic accuracy of One Step Nucleic Acid Amplification (OSNA) compared to sentinel lymph nodes histopathological ultrastaging in endometrial cancer patients. METHODS: Centres with expertise in sentinel lymph node mapping in endometrial cancer patients in Europe will be invited to participate in the study. Participating units will be trained on the correct usage of the OSNA RD-210 analyser and nucleic acid amplification reagent kit LYNOAMP CK19 E for rapid detection of metastatic nodal involvement, based on the cytokeratin 19 (CK19) mRNA detection. Endometrial cancer patients ≥ 18 years listed for surgical treatment with sentinel lymph node mapping, with no history of other types of cancer and who provide a valid written consent will be considered potentially eligible for the study. However, they will only be enrolled if a successful sentinel lymph node mapping is retrieved. Each node will be processed according to the study protocol and assessed by both OSNA and ultrastaging. DISCUSSION: The accuracy of OSNA (index test) will be assessed against sentinel lymph node histopathological ultrastaging (reference test). This European study has the potential to be the largest study on the use of OSNA in endometrial cancer to date. OSNA could represent a modern diagnostic alternative to sentinel lymph node ultrastaging with the added benefits of standardisation and fast results. TRIAL REGISTRATION: The study was registered in the German Clinical Trial Register - Nr. DRKS00021520, registration date 25th of May 2020, URL of the trial registry record: https://drks.de/search/en/trial/DRKS00021520 .

• MeSH
• Sentinel Lymph Node Biopsy methods   MeSH
• Keratin-19 genetics   MeSH
• Humans MeSH
• Lymphatic Metastasis * diagnosis   pathology   MeSH
• Lymph Nodes pathology   MeSH
• Multicenter Studies as Topic MeSH
• Endometrial Neoplasms * pathology   genetics   diagnosis   MeSH
• Prospective Studies MeSH
• Sentinel Lymph Node * pathology   MeSH
• Neoplasm Staging MeSH
• Nucleic Acid Amplification Techniques * methods   MeSH
• Check Tag
• Humans MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Clinical Trial Protocol MeSH
• Geographicals
• Europe MeSH

Východiska: Zatímco totální hysterektomie a bilaterální salpingo-ooforektomie bez stagingu lymfatických uzlin jsou standardní pro karcinom endometria s nízkým a středním rizikem, určité histopatologické faktory odhalené po operaci mohou vyžadovat další intervence. Naše studie hodnotila vliv biopsie sentinelové lymfatické uzliny na pooperační rozhodování. Materiál a metody: Do studie SENTRY (červenec 2021 – únor 2023) jsme zařadili pacientky s nízkým stupněm endometrioidního karcinomu endometria ve stadiu FIGO IA–IB. Laparoskopické mapování sentinelových lymfatických uzlin pomocí indocyaninové zeleně bylo provedeno spolu s totální hysterektomií s bilaterální salpingo-ooforektomií. Byly hodnoceny následné změny managementu na základě výsledků biopsie sentinelové lymfatické uzliny. Studie byla registrována na ClinicalTrials.gov (NCT04972682). Výsledky: Z celkového počtu 100 účastnic studie byla bilaterální detekce pozorována u 91 % pacientek při střední době detekce 10 min (mezikvartilové rozmezí 8–13 min). Metastázy sentinelové lymfatické uzliny byly nalezeny u 8 % (n = 8) účastníků. Pooperační FIGO staging se zvýšil u 15 % (n = 15) a snížil u 5 % (n = 5) pacientek. Výsledky biopsie sentinelové lymfatické uzliny změnily plán adjuvantní léčby u 20 % (n = 20): zevní radioterapie byla vynechána ve 12 % (n = 12), zatímco u 6 % (n = 6) byla přidána zevní radioterapie +/– systémová chemoterapie v důsledku metastáz sentinelových lymfatických uzlin. U 2 % (n = 2) bylo pole zevní radioterapie rozšířeno o paraaortální oblast. Nebyly hlášeny žádné peroperační komplikace a nebyla zaznamenána vyšší 30denní morbidita ani mortalita. Během střední doby sledování 14 měsíců (95% interval spolehlivosti 12–15 měsíců) se v souboru nevyskytly lymfedémy ani pánevní recidivy hlášené pacientkami. Závěr: Biopsie sentinelové lymfatické uzliny pomocí indocyaninové zeleně je bezpečný postup a umožňuje přizpůsobení adjuvantní terapie u předpokládaného karcinomu endometria s nízkým a středním rizikem. Pomáhá vyhnout se přeléčení externí radioterapií a v případě potřeby zavést další modality.

Background: While total hysterectomy and bilateral salpingo-oophorectomy without lymph node staging are standard for low- and intermediate-risk endometrial cancer, certain histopathologic factors revealed after surgery can necessitate additional interventions. Our study assessed the influence of sentinel lymph node biopsy on postoperative decision-making. Materials and methods: In the SENTRY trial (July 2021 – February 2023), we enrolled patients with International Federation of Gynaecology and Obstetrics (FIGO) stage IA–IB low-grade endometrioid endometrial cancer. Laparoscopic sentinel lymph node mapping using indocyanine green was performed alongside total hysterectomy with bilateral salpingo-oophorectomy. Subsequent management changes based on sentinel lymph node biopsy results were evaluated. The trial was registered at ClinicalTrials.gov (NCT04972682). Results: Of the 100 enrolled participants, a bilateral detection rate of 91% was observed with a median detection time of 10 min (interquartile range 8–13 min). Sentinel lymph node metastases were found in 8% (N = 8) of participants. Postoperative FIGO staging increased in 15% (N = 15) and decreased in 5% (N = 5) of patients. Sentinel lymph node biopsy results altered the adjuvant treatment plan for 20% (N = 20): external beam radiotherapy was omitted in 12% (N = 12) while 6% (N = 6) had external beam radiotherapy +/− systemic chemotherapy added due to sentinel lymph node metastases. In 2% (N = 2), the external beam radiotherapy field was expanded with the paraaortic region. No intraoperative complications were reported and no 30-day major morbidity and mortality occurred. Throughout a median follow-up of 14 (95% CI 12–15 months, neither patient-reported lymphedema nor pelvic recurrence surfaced in the cohort. Conclusions: Sentinel lymph node biopsy using indocyanine green is a safe procedure and allows tailoring adjuvant therapy in presumed low- and intermediate-risk endometrial cancer. It assists in avoiding external beam radiotherapy overtreatment and introducing additional modalities when necessary.

• MeSH
• Sentinel Lymph Node Biopsy * MeSH
• Indocyanine Green therapeutic use   MeSH
• Clinical Decision-Making MeSH
• Middle Aged MeSH
• Humans MeSH
• Uterine Neoplasms surgery   diagnostic imaging   pathology   therapy   MeSH
• Endometrial Neoplasms * surgery   diagnostic imaging   pathology   therapy   MeSH
• Aftercare methods   MeSH
• Postoperative Care methods   MeSH
• Risk MeSH
• Aged MeSH
• Neoplasm Staging methods   statistics & numerical data   MeSH
• Check Tag
• Middle Aged MeSH
• Humans MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Clinical Study MeSH

OBJECTIVE: The purpose of this study was to establish a consensus on the surgical technique for sentinel lymph node (SLN) dissection in cervical cancer. METHODS: A 26 question survey was emailed to international expert gynecological oncology surgeons. A two-step modified Delphi method was used to establish consensus. After a first round of online survey, the questions were amended and a second round, along with semistructured interviews was performed. Consensus was defined using a 70% cut-off for agreement. RESULTS: Twenty-five of 38 (65.8%) experts responded to the first and second rounds of the online survey. Agreement ≥70% was reached for 13 (50.0%) questions in the first round and for 15 (57.7%) in the final round. Consensus agreement identified 15 recommended, three optional, and five not recommended steps. Experts agreed on the following recommended procedures: use of indocyanine green as a tracer; superficial (with or without deep) injection at 3 and 9 o'clock; injection at the margins of uninvolved mucosa avoiding vaginal fornices; grasping the cervix with forceps only in part of the cervix is free of tumor; use of a minimally invasive approach for SLN biopsy in the case of simple trachelectomy/conization; identification of the ureter, obliterated umbilical artery, and external iliac vessels before SLN excision; commencing the dissection at the level of the uterine artery and continuing laterally; and completing dissection in one hemi-pelvis before proceeding to the contralateral side. Consensus was also reached in recommending against injection at 6 and 12 o'clock, and injection directly into the tumor in cases of the tumor completely replacing the cervix; against removal of nodes through port without protective maneuvers; absence of an ultrastaging protocol; and against modifying tracer concentration at the time of re-injection after mapping failure. CONCLUSION: Recommended, optional, and not recommended steps of SLN dissection in cervical cancer have been identified based on consensus among international experts. These represent a surgical guide that may be used by surgeons in clinical trials and for quality assurance in routine practice.

• MeSH
• Sentinel Lymph Node Biopsy methods   MeSH
• Indocyanine Green MeSH
• Consensus MeSH
• Humans MeSH
• Lymph Node Excision methods   MeSH
• Lymphatic Metastasis pathology   MeSH
• Lymph Nodes pathology   MeSH
• Uterine Cervical Neoplasms * surgery   pathology   MeSH
• Check Tag
• Humans MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

Cíl: Porovnání systémů k detekci sentinelových lymfatických uzlin u karcinomu endometria pomocí indocyaninové zeleně. Robotický Firefly Da Vinci fluorescence imaging vision system (Intuitive Surgical Inc., Sunnyvale, CA, USA) vs. laparoskopický Novadaq Pinpoint near-infrared imaging system (Novadaq, Ontario, Canada). Soubor a metodika: Patnáct pacientek s karcinomem endometria I. stadia podstoupilo detekci sentinelové lymfatické uzliny po intracervikální aplikaci indocyaninové zeleně. U všech byla detekce provedena pomocí obou zařízení. Byla hodnocena detekční schopnost, identifikační shoda a rozsah zobrazení lymfatického systému. Výsledky: Detekční schopnost obou systémů byla shodná, detekované sentinelové uzliny byly identické a lymfatický systém byl zobrazen ve shodném rozsahu. Kvalita zobrazení, jeho přehlednost a celková uživatelská přívětivost je u obou systémů odlišná v důsledku rozdílných technologií. Závěr: Oba systémy využívané v minimálně invazivní chirurgii umožňují perioperační zobrazení lymfatického systému pomocí ICG na vysoké úrovni.

Objective: Comparison of systems to detect sentinel lymph node in endometrial carcinoma using indocyanine green. Robotic Firefly Da Vinci fluorescence imaging system (Intuitive Surgical Inc., Sunnyvale, CA, USA) vs. laparoscopic Novadaq Pinpoint near-infrared imaging system (Novadaq, Ontario, Canada). Material and method: Fifteen patients with stage I endometrial cancer underwent sentinel lymph node biopsy after intracervical application of indocyanine green. For all of them, the detection was performed sequentially using both evaluated devices. The detection rate, identification match and extent of imaging of the lymphatic system were evaluated. Results: The detection rate of both systems verified on a set of patients was identical, the detected sentinel nodes were identical, and the lymphatic system was shown to the same extent. The quality of the display and overall user-friendliness is different due to the applied technologies. Conclusion: Both systems used in minimally invasive surgery provide excelent perioperative imaging of the lymphatic system.

• Keywords
• Da Vinci Firefly, Novadaq Pinpoin,
• MeSH
• Indocyanine Green MeSH
• Clinical Studies as Topic MeSH
• Laparoscopy MeSH
• Humans MeSH
• Endometrial Neoplasms * diagnostic imaging   complications   MeSH
• Robotic Surgical Procedures MeSH
• Sentinel Lymph Node * diagnostic imaging   MeSH
• Check Tag
• Humans MeSH
• Female MeSH

INTRODUCTION: The standard procedure in cervical cancer is radical hysterectomy and pelvic lymphadenectomy (PLND). Because of the increasing age of women bearing children, fertility has become a major challenge. We present pregnancy results after less radical fertility-sparing surgery in women with IA1, LVSI positive, IA2 and IB1 (<2 cm, infiltration less than half of the cervical stroma). MATERIALS AND METHOD: All women (n = 91) underwent laparoscopic sentinel lymph node mapping with frozen section followed by PLND and "selective parametrectomy" (removal of afferent lymphatic channels from the paracervix) if sentinel nodes (SLN) are negative. If lymph nodes were verified negative by definitive histopathology, patients were treated by simple trachelectomy (IB1) or large cone (IA1/IA2) biopsy 1 week after primary surgery. RESULTS: From 1999 to 2018, 91 women were enrolled in the study (median age 29.1 years, range 21-40). Fertility was spared in 76 (83.5%) women; 13 (17.1%) women did not plan future pregnancy and 63 (82.9%) had pregnancy desires. Fifty-four of 63 women conceived (pregnancy rate 85.7%) and 48 of 63 delivered 58 babies (delivery rate 76.2%). Thirty-nine women delivered in term (67.2%): 13 women between 32 and 36 + 6 weeks of pregnancy, 3 between 28 and 31 + 6 weeks and 3 between 24 and 27 + 6 weeks. Only one woman still plans pregnancy. One woman is currently pregnant. CONCLUSION: The goal of fertility-sparing surgery is to produce good oncological results and promising pregnancy outcomes. Pregnancy results after less radical fertility-sparing procedures show promise (pregnancy rate 82.9% and delivery rate 76.2%).

• MeSH
• Cervix Uteri pathology   MeSH
• Child MeSH
• Adult MeSH
• Fertility MeSH
• Hysterectomy methods   MeSH
• Humans MeSH
• Lymph Node Excision MeSH
• Young Adult MeSH
• Uterine Cervical Neoplasms * surgery   pathology   MeSH
• Neoplasm Staging MeSH
• Pregnancy MeSH
• Pregnancy Outcome * MeSH
• Check Tag
• Child MeSH
• Adult MeSH
• Humans MeSH
• Young Adult MeSH
• Male MeSH
• Pregnancy MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH

BACKGROUND: Sentinel node biopsy in vulvar cancer is associated with much less morbidity than inguinofemoral node dissection. Our study focused on describing the morphology of superficial lymphatic drainage of the vulva and its relationship to regional nodes, which may facilitate orientation during surgery. MATERIALS AND METHODS: In 24 female cadavers, injections of patent blue (at various localisations medially, unilaterally and bilaterally) were used to visualise the lymphatic drainage of the vulva. After dissection of lymphatic vessels and nodes, their course was documented by photograph and then analysed. Subsequently, a map of vulvar superficial lymphatics was created. RESULTS: The cutaneous and subcutaneous tissue of the vulva primarily drained to superficial inguinal nodes. There was no evidence of a solitary lymph node that drained the unilateral vulva. Each area of the vulva drained to its own lymph node, which was variably localised in the subcutaneous groin around the great saphenous vein. Anastomoses between individual inguinal superficial lymph nodes are likely. Right-left symmetry in the course of lymphatic collectors was not detected. Natural drainage of the medial and paramedial areas to contralateral inguinal nodes was also not detected. The drainage pattern to ipsilateral inguinal nodes was consistent in cadavers without evidence of vulvar disease and may be applicable in the early stages of vulvar cancer. CONCLUSIONS: There was no evidence of a solitary node that drained the unilateral vulva. Each part of the vulva may drain to a corresponding lymph node in a different localisation of the groin. The surgeon should take this variability into account.

• MeSH
• Sentinel Lymph Node Biopsy MeSH
• Humans MeSH
• Lymphatic Vessels * pathology   MeSH
• Lymph Nodes pathology   MeSH
• Vulvar Neoplasms * pathology   MeSH
• Groin pathology   MeSH
• Check Tag
• Humans MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

Koncept sentinelové uzliny hraje v onkologické chirurgii čím dál důležitější roli, díky níž jsme schopni snížit operační zátěž pacientů a s ní spojenou morbiditu při zachování adekvátní onkologické bezpečnosti. V poslední době také dochází k rozvoji technik lymfatického mapování, z nichž nejslibnější výsledky přináší imunofluorescenční metoda s indocyaninovou zelení. Tato technika dosahuje v onkogynekologii vysoké senzitivity v detekci sentinelové uzliny a mohla by nahradit stávající metody s využitím barviva v kombinaci s radionuklidem, oproti kterým má barvení pomocí indocyaninovou zelení několik výhod. Zároveň lze tuto metodu použít i u neonkologických indikací v gynekologické operativě.

In oncological surgery the importance of the sentinel node concept is increasing, as we are capable of reducing the surgical burden of patients and its associated morbidity and preserving adequate oncological safety at the same time. Recently, there has been development of lymph node mapping techniques, where the most promising method appears to be the immunofluorescent one using indocyanine green dye. This technique provides high sensitivity in sentinel node detection in comparison with other existing methods using a dye in combination with a radionuclide. The indocyanine green technique has several advantages, and at the same time, we can use this method in non-oncological indications in gynecological surgery.

• MeSH
• Sentinel Lymph Node Biopsy MeSH
• Indocyanine Green MeSH
• Humans MeSH
• Lymphatic Metastasis * diagnosis   MeSH
• Genital Neoplasms, Female * diagnosis   MeSH
• Check Tag
• Humans MeSH
• Female MeSH
• Publication type
• Review MeSH

The aim of the study was to map the lymphatic drainage of the upper extremity that traverses the axilla and elucidate its relationship with the lymphatic drainage of the breast. In 79 breast cancer patients indicated to the axillary lymph node dissection for category cN1, cN2, Technetium-99m (particle size <80 nm) was applied prior to surgery at two injection sites between the second and third metacarpophalangeal joints to visualize upper extremity lymphatics. During the surgery, the axilla was anatomically divided into 6 quadrants. A C-Trak® device was used for the intraoperative detection of radioactivity. After verifying activity, the nodes were resected and their position was recorded. Active nodes were sent separately according to topographic localizations for microscopic examination. All affected nodes (both macro- and micrometastases) were recorded as positive. The location, involvement and radioactivity, and the number of lymph nodes obtained were analyzed. In total, 1,109 lymph nodes were removed and examined. Radioactive nodes were found in all 79 patients. A total of 230 radioactive nodes were found. 21 nodes were both radioactive and metastatically affected. Results show that part of the lymph from the upper extremity flows through the nodes in the central part of the axilla and mixes with the lymph from the breast. This suggests that lymphatic drainage of the upper limb cannot be functionally separated from lymphatic drainage of the breast. The results also explain the possible mechanical cause of arm lymphedema after sentinel lymph node biopsy.

• MeSH
• Axilla pathology   MeSH
• Sentinel Lymph Node Biopsy adverse effects   methods   MeSH
• Humans MeSH
• Lymph Node Excision adverse effects   MeSH
• Lymph Nodes pathology   surgery   MeSH
• Lymphedema * etiology   pathology   surgery   MeSH
• Mastectomy adverse effects   MeSH
• Breast Neoplasms * pathology   surgery   MeSH
• Check Tag
• Humans MeSH
• Female MeSH
• Publication type
• Journal Article MeSH

INTRODUCTION: The standard procedure in cervical cancer is radical hysterectomy (RH) and pelvic lymphadenectomy (PLND). Because of the increasing age of women at childbirth, fertility becomes a major challenge. We present 20 years of experience with two-step less radical fertility-sparing surgery in women with IA1, LVSI positive, IA2 and IB1 (<2 cm, infiltration less than half of stromal invasions. MATERIALS AND METHOD: Preoperative workout consisted of histopathological diagnosis and magnetic resonance imaging along with ultrasonographic volumetry. We then performed laparoscopic sentinel lymph node mapping (SLNM) with frozen section (FS) followed by PLND and "selective parametrectomy" (removal of afferent lymphatic channels from the paracervix) in case of a negative result. If verified by definitive histopathology, patients were treated by simple trachelectomy (IB1) or large cone (IA1/IA2) biopsy 1 week after primary surgery. RESULTS: From 1999 to 2018, 91 women were enrolled in the study (median age 29.1 years, range 21-40). Of these 91 women, 51 (56.0%) were nulliparous. The detection rate of SLNs was 100% per patient and the specific side detection rate 96.7%. Positive lymph nodes were diagnosed in nine cases (9.8%). These women then underwent RH. Fertility was spared in 80 women but 4 recurred locally (5.0%). The mortality rate was 0.0%. The median follow-up was 149 months. CONCLUSION: Less radical fertility-sparing surgery with SLNM is safe in cervical cancers <2 cm at the largest diameter and infiltrating less than half of the cervical stroma. The recurrence rate is acceptable with no mortality. Morbidity with this procedure is low. Extended and accurate follow-up is necessary and human papillomavirus - high risk (HPV-HR tests seem to be useful in such follow-up assessment.

• MeSH
• Adult MeSH
• Hysterectomy * MeSH
• Humans MeSH
• Neoplasm Recurrence, Local epidemiology   MeSH
• Lymph Node Excision * MeSH
• Young Adult MeSH
• Uterine Cervical Neoplasms mortality   pathology   surgery   MeSH
• Prospective Studies MeSH
• Neoplasm Staging MeSH
• Trachelectomy MeSH
• Fertility Preservation * MeSH
• Check Tag
• Adult MeSH
• Humans MeSH
• Young Adult MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Research Support, Non-U.S. Gov't MeSH

BACKGROUND: SENTIX (ENGOT-CX2/CEEGOG-CX1) is an international, multicentre, prospective observational trial evaluating sentinel lymph node (SLN) biopsy without pelvic lymph node dissection in patients with early-stage cervical cancer. We report the final preplanned analysis of the secondary end-points: SLN mapping and outcomes of intraoperative SLN pathology. METHODS: Forty-seven sites (18 countries) with experience of SLN biopsy participated in SENTIX. We preregistered patients with stage IA1/lymphovascular space invasion-positive to IB2 (4 cm or smaller or 2 cm or smaller for fertility-sparing treatment) cervical cancer without suspicious lymph nodes on imaging before surgery. SLN frozen section assessment and pathological ultrastaging were mandatory. Patients were registered postoperatively if SLN were bilaterally detected in the pelvis, and frozen sections were negative. TRIAL REGISTRATION: ClinicalTrials.gov (NCT02494063). RESULTS: We analysed data for 395 preregistered patients. Bilateral detection was achieved in 91% (355/395), and it was unaffected by tumour size, tumour stage or body mass index, but it was lower in older patients, in patients who underwent open surgery, and in sites with fewer cases. No SLN were found outside the seven anatomical pelvic regions. Most SLN and positive SLN were localised below the common iliac artery bifurcation. Single positive SLN above the iliac bifurcation were found in 2% of cases. Frozen sections failed to detect 54% of positive lymph nodes (pN1), including 28% of cases with macrometastases and 90% with micrometastases. INTERPRETATION: SLN biopsy can achieve high bilateral SLN detection in patients with tumours of 4 cm or smaller. At experienced centres, all SLN were found in the pelvis, and most were located below the iliac vessel bifurcation. SLN frozen section assessment is an unreliable tool for intraoperative triage because it only detects about half of N1 cases.

• MeSH
• Sentinel Lymph Node Biopsy methods   MeSH
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Uterine Cervical Neoplasms pathology   surgery   MeSH
• Prospective Studies MeSH
• Aged MeSH
• Sentinel Lymph Node pathology   MeSH
• Check Tag
• Adult MeSH
• Middle Aged MeSH
• Humans MeSH
• Aged MeSH
• Female MeSH
• Publication type
• Journal Article MeSH
• Multicenter Study MeSH
• Research Support, Non-U.S. Gov't MeSH