Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastrectomies for Gastric Cancer (PhotoNodes)
NCT Number: NCT06466902
Acronym: PhotoNodes
Status: RECRUITING
Study Type: OBSERVATIONAL
Conditions: Gastric Cancer|Gastric Adenocarcinoma|Lymphadenectomy|Minimally Invasive Surgery|Gastrectomy for Gastric Cancer|Laparoscopic Surgery|Robotic Surgery|Survival Outcomes|Survival Analysis|Quality Of Care
Interventions: OTHER: Quality assessment of D2 lymphadenectomy using the PhotoNode Score
Sponsor: Azienda Ospedaliero-Universitaria di Parma
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 326
Study Design: Observational Model: |Time Perspective: p
Start Date: 2022-12-22
Completion Date: 2027-12
Locations: Ospedale di Cremona - UOC Chirurgia Generale, Cremona, CR, 26100, Italy|Azienda Ospedaliera Universitaria Careggi - Chirurgia dell'Apparato Digerente, Firenze, FI, 50134, Italy|Ospedale San Raffaele - Chirurgia Gastroenterologica, Milano, MI, 20132, Italy|Istituto Europeo di Oncologia, Milano, MI, 20139, Italy|ASST Grande Ospedale Metropolitano Niguarda, Milano, MI, 20162, Italy|Policlinico Abano, Abano Terme, PD, 35031, Italy|Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco, Verona, VR, 37124, Italy|Azienda Ospedaliero-Universitaria di Parma, Parma, 43100, Italy

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.

Primary Outcome Measures: PhotoNode Score interobserver agreement, A PhotoNode Score for each patient will be obtained from each reviewer and the interobserver agreement among the reviewers will be analyzed.

The range of the PhotoNodes Score will go from a minimum of 7 (poor lymphadenectomy) to a maximum of 24 (excellent lymphadenectomy), At the end of enrollment period
Secondary Outcome Measures: Association between PhotoNode Score and disease-free, 1-year and 3-year overall survival, An average PhotoNode Score for each patient will originate from the average score among the three reviewers. This PhotoNode Score will correlate with clinical endpoints, including disease-free and overall survival., Data for follow up will be extracted through a 6-monthly medical chart review until 3 years after the end of enrollment period
Other Outcome Measures: Correlation between PhotoNode Score and number of harvested lymph nodes., Any correlation between PNS and number of harvested lymph nodes will also be analyzed, 8 weeks after the end of enrollment period