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.

Center for Gynecologic Oncology Amsterdam University Medical Center Amsterdam the Netherlands

Department of Gynaecology and Obstetrics University Hospital Comenius University Bratislava Slovakia

Department of Gynaecology and Obstetrics University Hospital Pilsen Charles University Prague Czech Republic

Department of Gynaecology St Olav's Hospital Trondheim Norway

Department of Gynecologic Oncology Centre of Oncology M Sklodowska Curie Memorial Institute Cracow Department Cracow Poland

Department of Gynecologic Oncology Holycross Cancer Center Kielce Poland

Department of Gynecologic Oncology University Hospital of the Canary Islands Las Palmas de Gran Canaria Spain

Department of Gynecology and Obstetrics Faculty of Medicine Masaryk University Brno Czech Republic

Department of Gynecology and Obstetrics University Hospital Leuven Leuven Cancer Institute Leuven Belgium

Department of Gynecology Francisco Gentil Portuguese Oncology Institute Porto Portugal

Department of Gynecology Gynecologic Oncology and Gynecologic Endocrinology Medical University of Gdansk Poland

Department of Gynecology Institute of Oncology Angel H Roffo University of Buenos Aires Buenos Aires Autonomous City Argentina

Department of Gynecology University Hospital of Bellvitge Biomedical Research Institute of Bellvitge University of Barcelona Barcelona Spain

Department of Obstetrics and Gynaecology Hospital Ceske Budejovice JSC Ceske Budejovice Czech Republic

Department of Obstetrics and Gynecology Bulovka Hospital 1st Faculty of Medicine Charles University Prague Czech Republic

Department of Obstetrics and Gynecology Cantonal Hospital of Lucerne Lucerne Switzerland

Department of Obstetrics and Gynecology Faculty Hospital Trencin Trencin Slovakia

Department of Obstetrics and Gynecology Faculty of Medicine and Dentistry Palacky University University Hospital Olomouc Olomouc Czech Republic

Department of Obstetrics and Gynecology KNTB a s Zlin Czech Republic

Department of Obstetrics and Gynecology Unit of Gynecologic Oncology Surgery San Gerardo Hospital Monza Italy

Department of Obstetrics and Gynecology University Hospital Ostrava Ostrava Poruba Czech Republic

Department of Radiation Oncology CyberKnife and Radiotherapy University Hospital Cologne Cologne Germany

Department of Special Operative and Oncologic Gynaecology Asklepios Clinic Hamburg Hamburg Germany

Fondazione IRCCS Istituto Nazionale Tumori Milan Milan Italy

Gynaecologic Oncology Unit Department of Obstetrics and Gynaecology University of Pretoria Pretoria South Africa

Gynecologic Oncology Center Department of Obstetrics and Gynecology 1st Faculty of Medicine Charles University and General University Hospital Prague Czech Republic

Gynecologic Oncology Unit La Paz University Hospital Madrid Spain

Gynecology Department Instituto Valenciano de Oncologia Valencia Spain

Institute of Biostatistics and Analyses Faculty of Medicine Masaryk University Brno Czech Republic

Institute of Pathology 1st Faculty of Medicine Charles University and General University Hospital Prague Prague Czech Republic

LISOD Israeli Oncological Hospital Plyuty Ukraine

Unit of Gynecological Oncology Institute Clinic of Gynaecology Obstetrics and Neonatology Hospital Clinic Institut d'Investigacions Biomediques August Pi i Sunyer University of Barcelona Barcelona Spain

University Clinic for Gynaecology and Perinatology University Medical Centre Maribor Maribor Slovenia

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ClinicalTrials.gov
NCT02494063