RecruitingNCT06466902

Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastrectomies for Gastric Cancer (PhotoNodes)

Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastric Cancer Surgery (PhotoNodes)


Sponsor

Azienda Ospedaliero-Universitaria di Parma

Enrollment

326 participants

Start Date

Dec 22, 2022

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating whether intraoperative photographs taken during minimally invasive stomach cancer surgery can reliably confirm that an adequate number of lymph nodes were removed — which is critical to ensure complete cancer removal. **You may be eligible if...** - You are undergoing minimally invasive (laparoscopic or robotic) surgery for stomach (gastric) adenocarcinoma - You are having a D2 lymph node removal (an extensive but standard dissection) - You are having total or subtotal gastrectomy, with or without prior chemotherapy **You may NOT be eligible if...** - You are under 18 years old - Your cancer is at the junction of the esophagus and stomach (esophago-gastric junction) - Your cancer has spread to distant sites (metastatic) - You require open surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERQuality assessment of D2 lymphadenectomy using the PhotoNode Score

During the surgical procedure, a set of 5 high quality laparoscopic intraoperative images of the surgical field will be put on record. Photographs will be taken at the end of the lymphadenectomy phase, before the reconstructive phase begins. Three surgeons will review the images. Quality of D2 lymphadenectomy will be assessed independently rating eight node stations (1, 5, 6, 7, 8a, 9, 11p and 12a), based upon the evaluation of the 5 images. Each node station will be given a score from 0 to 3, corresponding to a judgment of Unevaluable (0), Poor (1), Doubtful (2) or Excellent (3) lymphadenectomy respectively, in that specific node station. A total score for each patient will be independently obtained from each reviewer ranging from a minimum of 7 (poor lymphadenectomy) to a maximum of 24 (excellent lymphadenectomy). The PNS for each patient will originate from the average score among the three reviewers.


Locations(8)

Ospedale di Cremona - UOC Chirurgia Generale

Cremona, CR, Italy

Azienda Ospedaliera Universitaria Careggi - Chirurgia dell'Apparato Digerente

Florence, FI, Italy

Ospedale San Raffaele - Chirurgia Gastroenterologica

Milan, MI, Italy

Istituto Europeo di Oncologia

Milan, MI, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, MI, Italy

Policlinico Abano

Abano Terme, PD, Italy

Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco

Verona, VR, Italy

Azienda Ospedaliero-Universitaria di Parma

Parma, Italy

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06466902


Related Trials