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

Azienda Ospedaliero-Universitaria di Parma

Status: Enrolling

Conditions: Laparoscopic Surgery; Gastrectomy for Gastric Cancer; Quality Of Care; Gastric Cancer; Survival Outcomes; Minimally Invasive Surgery; Lymphadenectomy; Survival Analysis; Robotic Surgery; Gastric Adenocarcinoma

Treatments: Other: Quality assessment of D2 lymphadenectomy using the PhotoNode Score

Study type: Observational

Funder types: Other

Identifiers

NCT06466902

649/2022/OSS/AOUPR

Details and patient eligibility

About

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.

Enrollment: 326 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

326 participants in 1 patient group

Patients undergoing minimally invasive gastrectomy

Description:

Patients undergoing minimally invasive gastrectomy with D2 lymphadenectomy for gastric cancer

Treatment:

Other: Quality assessment of D2 lymphadenectomy using the PhotoNode Score