Assessing lymph node removal quality during minimally invasive gastric cancer surgery
Official title: Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastric Cancer Surgery (PhotoNodes)
Run by Azienda Ospedaliero-Universitaria di Parma · NCT06466902 · Data updated 2026-11-12
This study is testing a new scoring system to see if it can help doctors better assess lymph node removal during minimally invasive surgery for stomach cancer and improve patient outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 326 (estimated) |
| Sponsor | Azienda Ospedaliero-Universitaria di Parma Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Cremona, CR and 7 other locations) |
| Status | Recruiting |
| Started | December 22, 2022 |
| Main results expected | December 2024 |
| Study ends | December 2027 |
| Registry record updated | July 5, 2024 |
| Trial ID | NCT06466902 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults undergoing minimally invasive curative-intent surgery for gastric adenocarcinoma with D2 lymphadenectomy.
✕Probably not a fit
Patients with metastatic disease or those undergoing palliative procedures will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study evaluates the effectiveness of a new scoring system, the PhotoNodes Score, to assess the quality of D2 lymphadenectomy during minimally invasive surgeries for gastric adenocarcinoma. The study aims to determine if this score can reliably indicate the absence of residual lymph nodes, which may correlate better with patient survival outcomes than the total number of nodes removed. It involves multiple centers and includes patients undergoing either upfront surgery or those treated with neoadjuvant chemotherapy. The goal is to improve surgical assessment and potentially enhance patient outcomes in gastric cancer treatment.
Why it matters
Potential benefit: If successful, this study could lead to improved surgical techniques and better survival rates for patients with gastric cancer.
How similar studies have gone: While the approach of using a scoring system for lymphadenectomy assessment is innovative, similar studies have shown that thorough lymph node evaluation is crucial for improving cancer outcomes.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
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Ospedale di Cremona - UOC Chirurgia Generale
Cremona, Cr, Italy Recruiting -
Azienda Ospedaliera Universitaria Careggi - Chirurgia dell'Apparato Digerente
Florence, Fi, Italy Recruiting -
Istituto Europeo di Oncologia
Milan, Mi, Italy Recruiting -
ASST Grande Ospedale Metropolitano Niguarda
Milan, Mi, Italy Recruiting -
Policlinico Abano
Abano Terme, Pd, Italy Recruiting -
Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco
Verona, Vr, Italy Recruiting
Show 2 more locations
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Azienda Ospedaliero-Universitaria di Parma
Parma, Italy Recruiting -
Ospedale San Raffaele - Chirurgia Gastroenterologica
Milan, Mi, Italy Not yet recruiting
Study contacts
- Principal investigator: Federico Marchesi, Prof. — Azienda Ospedaliero-Universitaria di Parma
- Study coordinator: Federico Marchesi, Prof
- Email: federico.marchesi@unipr.it
- Phone: 00390521906343
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.