Image-Guided Robotic Surgery for Sentinel Lymph Node Status Assessment in Uterine Cancers Using Ultrasound Drop-in Probe: Surgical Technique in 10 Steps.
Matteo Pavone, Elena Teodorico, Nicolò Bizzarri...
https://pubmed.ncbi.nlm.nih.gov/39893338Actively Recruiting
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-06-15
160
Participants Needed
1
Research Sites
21 weeks
Total Duration
The trial focuses on women with gynecological cancers such as ovarian, endometrial, and cervical cancers who require robotic surgery involving lymph node removal. It aims to evaluate an image-guided ultrasound technique used during robotic surgery to assess lymph node status and detect metastases. This approach seeks to improve upon current staging methods by reducing unnecessary extensive lymphadenectomies that can cause complications, while helping to guide surgical and pathological decisions more accurately. Participants will undergo intraoperative robotic ultrasound using a drop-in probe to examine lymph nodes while still in the body. The study compares the ultrasound findings against the definitive pathology results to determine how well the technique detects lymph node metastases, including macro- and micro-metastases and isolated tumor cells. The use of this imaging technique may help avoid the risks and drawbacks of traditional frozen section analysis and extensive lymph node removal. During the study, women scheduled for robotic surgery for gynecological malignancies will have their lymph nodes examined with the ultrasound probe. Researchers will evaluate lymph node morphology and imaging characteristics, monitor the sensitivity of the robotic ultrasound in detecting metastases over two years, and assess the use of the drop-in ultrasound probe. Participation involves standard surgical care plus the additional ultrasound assessment, with data collected for research purposes throughout the procedure and follow-up period.
CONDITIONS
Image-guided Ultrasound Robotic Intraoperative Evaluation of Lymph-nodes Status in Gynecological Malignancies
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Surgery day and immediate recovery period
Participants undergo robotic surgery during which intraoperative robotic ultrasound is performed on lymph nodes to evaluate their morphology and imaging characteristics.
1 surgical visit (in-person) and immediate post-operative monitoring
Duration - Up to 2 years
Participants are monitored after surgery to assess outcomes and collect data on the diagnostic performance of the imaging technique compared to pathology.
Periodic follow-up visits up to 2 years
Total: 1 location
1
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Actively Recruiting
A
Antonia Carla Testa
E
Elena Teodorico
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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Matteo Pavone, Elena Teodorico, Nicolò Bizzarri...
https://pubmed.ncbi.nlm.nih.gov/39893338