Image-guided Ultrasound Robotic Intraoperative Evaluation of Lymph-nodes Status in Gynecological Malignancies

Overview

The assessment of lymph node status is of crucial importance in gynaecological malignancies. Indeed, the prognosis and adjuvant treatment regimens are strongly influenced by the presence of nodal involvement. Systematic extensive lymphadenectomies are often performed for staging, diagnosis of skip metastases and to define the radiation field when radiotherapy treatments are required. Nevertheless, these can lead to significant short-term and long-term lymphatic complications, which are difficult to justify if the lymph nodes are free from metastasis. To avoid unnecessary comprehensive procedures in early-stage cancers, evaluation of the sentinel lymph node has acquired a valuable role even if limitations are still present (rate of frozen section false negative, "empty packets" and mapping failure). The introduction of an intra-operative non-invasive imaging technique capable of describing the presence and characteristics of lymph nodes could help in (1) eliminating the risk of empty packet, (2) orienting the intraoperative decision while avoiding the drawbacks of frozen section (time and resources, partial destruction of the tissue material), (3) orientate the pathological section if frozen section is used. To date, technological advancements have paved the way for enhanced intra-operative assessment of cancerous organs and lesions. Over the past decade, the evolution of robotic surgery combined with advancements in image-guided surgery techniques has led to the introduction of ultrasound probes designed specifically for intraoperative ultrasound during robotic surgery (RIOUS). Apart from the conventional rigid laparoscopic probes, which can be inserted through an accessory trocar, there are robotic probes tailored to fit device arms, and drop-in flexible probes that are becoming increasingly relevant in the scientific panorama. Notably, the latter drop-in probes feature a rigid segment designed for compatibility with robotic graspers, leveraging the dexterity and rotational manoeuvrability inherent to robotic surgery. Such probes, already proven effective in evaluating liver and kidney lesions as well as tumour margins, hold promise for intraoperative lymph node assessments due to the possibility of reaching difficult anatomical spaces thanks to the robotic-assisted movements

Detailed description

Women undergoing radical surgery for gynecological cancers who meet the inclusion criteria in absence of exclusion criteria will be considered candidate for the study. Intraoperative robotic ultrasound will be performed on in vivo lymph nodal samples. Lymph nodes morphology and imaging characteristics will be evaluated. The gold standard will be definitive pathology.

Interventions

• Procedure image-guided surgery technique
  The identification of an image-guided surgery technique capable of intraoperatively detecting the presence of lymph node metastases would overcome the disadvantages and complications of extensive staging lymphadenectomies.

Primary outcome measures

• Sensitivity of RIUS in detecting lymph node metastases (macro-, micro-metastases and isolated tumor cells) [Time frame: 2 year]

Secondary outcome measures (1)

• drop-in robotic ultrasound probe [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

• Women undergoing robotic surgery for gynecological malignancies (ovarian, endometrial, cervical cencers)
• Need for nodal excision (staging or cytoreductive reasons)
• 18-99 years old
• Absence of contemporary lymphatic diseases
• Absence of previous oncological disease in the last 5 years
• Willingness to participate in the study and to provide informed consent

Exclusion criteria

• \- Previous radiotherapy treatments in the area of analysed lymph nodes
• Previous chemotherapy treatments

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

Italy · 1 center

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Roma

Publications

• Pavone M, Teodorico E, Bizzarri N, Innocenzi C, Rosati A, Zorzi M, Cantarini C, Ciancia M, Moro F, Gallotta V, Marescaux J, Lecointre L, Fagotti A, Scambia G, Fanfani F, Testa A, Querleu D. Image-Guided Robotic Surgery for Sentinel Lymph Node Status Assessment in Uterine Cancers Using Ultrasound Drop-in Probe: Surgical Technique in 10 Steps. Ann Surg Oncol. 2025 May;32(5):3465-3466. doi: 10.1245/s PMID 39893338

Identifiers

NCT: NCT06621823 · 6534

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗