Gastrectomy for Gastric Cancer, Gastric Adenocarcinoma, Gastric Cancer, Laparoscopic Surgery, Lymphadenectomy, Minimally Invasive Surgery, Quality Of Care, Robotic Surgery, Survival Analysis, Survival Outcomes
Conditions
Keywords
D2 Lymphadenectomy quality assessment, Minimally invasive gastric cancer oncologic surgery
Brief 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.
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.
Sponsors
Azienda Ospedaliero-Universitaria di Parma
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PhotoNode Score interobserver agreement | At the end of enrollment period | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Association between PhotoNode Score and disease-free, 1-year and 3-year 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Correlation between PhotoNode Score and number of harvested lymph nodes. | 8 weeks after the end of enrollment period | Any correlation between PNS and number of harvested lymph nodes will also be analyzed |
Countries
Italy
Contacts
Primary ContactFederico Marchesi, Prof
Backup ContactGiorgio Dalmonte, MD, PhD
Outcome results
None listed