Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06621823
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-05-20
Brief Title:
Image-guided Ultrasound Robotic Intraoperative Evaluation of Lymph-nodes Status in Gynecological Malignancies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Image-guided Ultrasound Robotic Intraoperative Evaluation of Lymph-nodes Status in Gynecological Malignancies
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
R-LYNUS
Brief Summary:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None