Assessing lymph node removal quality during minimally invasive gastric cancer surgery
Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastric Cancer Surgery (PhotoNodes)
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 |
|---|---|
| Enrollment | 326 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Azienda Ospedaliero-Universitaria di Parma Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 8 sites (Cremona, CR and 7 other locations) |
| Trial ID | NCT06466902 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults undergoing minimally invasive curative-intent surgery for gastric adenocarcinoma with D2 lymphadenectomy.
Not a fit: Patients with metastatic disease or those undergoing palliative procedures will not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Cremona, CR and 7 other locations
- Ospedale di Cremona - UOC Chirurgia Generale — Cremona, Cr, Italy (Recruiting)
- Azienda Ospedaliera Universitaria Careggi - Chirurgia dell'Apparato Digerente — Florence, Fi, Italy (Recruiting)
- Ospedale San Raffaele - Chirurgia Gastroenterologica — Milan, Mi, Italy (Not_yet_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)
- Azienda Ospedaliero-Universitaria di Parma — Parma, Italy (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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.