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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-99
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

- Previous radiotherapy treatments in the area of analysed lymph nodes

Previous chemotherapy treatments

Trial design

Design model

Single group

Treatments tested in this trial

  • image-guided surgery technique

    Procedure/Surgery

    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.

Treatment groups

160 Participants
are divided into 1 treatment group
Group A: surgical lymph nodesOther 1 intervention

Trial outcomes

Primary outcomes

1

Sensitivity of RIUS in detecting lymph node metastases (macro-, micro-metastases and isolated tumor cells)

The aim of this prospective trial is to evaluate the sensitivity of Real-time Intraoperative Ultrasound (RIUS) in detecting lymph node metastases, including macrometastases, micrometastases, and isolated tumor cells (ITCs), using fresh, unstained in vivo lymph node samples. Ultrasound images will be assessed according to the VITA (Vulva International Tumor Analysis) group consensus on morphological parameters. Final histopathological examination will serve as the gold standard for comparison.

Time frame
2 year

Secondary outcomes

1

drop-in robotic ultrasound probe

The secondary endpoint is to assess the lowest size detectable with the adopted drop-in robotic ultrasound probe

Time frame
2 years

Other outcomes

Sponsors and contacts

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