NCT06466902 Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastrectomies for Gastric Cancer (PhotoNodes)
| NCT ID | NCT06466902 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliero-Universitaria di Parma |
| Condition | Gastric Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 326 participants |
| Start Date | 2022-12-22 |
| Primary Completion | 2024-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 326 participants in total. It began in 2022-12-22 with a primary completion date of 2024-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Even after the wide introduction of chemo/radiotherapy in the treatment algorithm, adequate surgery remains the cornerstone of gastric cancer treatment with curative intent. A proper D2 lymphadenectomy is associated with improved cancer specific survival as confirmed in Western countries by fifteen-year follow-up results of Dutch and Italian randomized trials. In clinical practice, the total number of harvested lymph nodes is often considered as a surrogate marker for adequate D2 lymphadenectomy; nonetheless, the number of retrieved nodes does not necessarily correlate with residual nodes, which intuitively could represent a more reliable marker of surgical adequacy. The availability of an efficient tool for evaluating the absence of residual nodes in the operative field at the end of node dissection could better correlate with survival outcomes. The goal of this multicentric observational prospective study is to test the reliability of a new score (PhotoNodes Score) created to rate the quality of the lymphadenectomy performed during minimally invasive gastrectomy for gastric cancer. The score is assigned by assessing the absence of residual nodes at the end of node dissection on a set of laparoscopic/robotic high quality intraoperative images collected from each patient undergoing a minimally invasive gastrectomy with D2 node dissection. Ideally, this tool could be a new indicator of the quality of D2 dissection and could assume a prognostic role in the treatment of gastric cancer.
Eligibility Criteria
Inclusion Criteria: * All patients undergoing minimally invasive curative-intent surgery for gastric adenocarcinoma with D2 lymphadenectomy * Patients undergoing upfront surgery or treated with a neoadjuvant/perioperative chemotherapy * Total or Subtotal Gastrectomy * Laparoscopic or Robotic approach Exclusion Criteria: * Age less than 18 year old * Esophago-gastric junction cancer Siewert type I, II or III * Metastatic disease * Lymphadenectomy less than D2 * Open surgery * Conversion to open surgery * Palliative gastrectomy * R1 or R2 resection * Multivisceral resection except for cholecystectomy * Surgical procedures other than subtotal or total gastrectomy * A single node station rated as unevaluable by more than one reviewer
Contact & Investigator
Giorgio Dalmonte, MD, PhD
STUDY CHAIR
Azienda Ospedaliero-Universitaria di Parma
Frequently Asked Questions
Who can join the NCT06466902 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06466902 currently recruiting?
Yes, NCT06466902 is actively recruiting participants. Contact the research team at federico.marchesi@unipr.it for enrollment information.
Where is the NCT06466902 trial being conducted?
This trial is being conducted at Cremona, Italy, Florence, Italy, Milan, Italy, Milan, Italy and 4 additional locations.
Who is sponsoring the NCT06466902 clinical trial?
NCT06466902 is sponsored by Azienda Ospedaliero-Universitaria di Parma. The principal investigator is Giorgio Dalmonte, MD, PhD at Azienda Ospedaliero-Universitaria di Parma. The trial plans to enroll 326 participants.
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