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.
Study Type
OBSERVATIONAL
Enrollment
326
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.
Ospedale di Cremona - UOC Chirurgia Generale
Cremona, CR, Italy
RECRUITINGAzienda Ospedaliera Universitaria Careggi - Chirurgia dell'Apparato Digerente
Florence, FI, Italy
RECRUITINGOspedale San Raffaele - Chirurgia Gastroenterologica
Milan, MI, Italy
NOT_YET_RECRUITINGIstituto Europeo di Oncologia
Milan, MI, Italy
RECRUITINGASST Grande Ospedale Metropolitano Niguarda
Milan, MI, Italy
RECRUITINGPoliclinico Abano
Abano Terme, PD, Italy
RECRUITINGAzienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco
Verona, VR, Italy
RECRUITINGAzienda Ospedaliero-Universitaria di Parma
Parma, Italy
RECRUITINGPhotoNode 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)
Time frame: At the end of enrollment period
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.
Time frame: Data for follow up will be extracted through a 6-monthly medical chart review until 3 years after the end of enrollment period
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