Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastrectomies for Gastric Cancer (PhotoNodes)
- Conditions
- Gastric AdenocarcinomaSurvival OutcomesLymphadenectomyRobotic SurgeryGastric CancerMinimally Invasive SurgeryGastrectomy for Gastric CancerLaparoscopic SurgerySurvival AnalysisQuality Of Care
- Interventions
- Other: Quality assessment of D2 lymphadenectomy using the PhotoNode Score
- Registration Number
- NCT06466902
- Lead Sponsor
- Azienda Ospedaliero-Universitaria di Parma
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 326
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients undergoing minimally invasive gastrectomy Quality assessment of D2 lymphadenectomy using the PhotoNode Score Patients undergoing minimally invasive gastrectomy with D2 lymphadenectomy for gastric cancer
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (8)
Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco
🇮🇹Verona, VR, Italy
Ospedale di Cremona - UOC Chirurgia Generale
🇮🇹Cremona, CR, Italy
Azienda Ospedaliera Universitaria Careggi - Chirurgia dell'Apparato Digerente
🇮🇹Firenze, FI, Italy
Ospedale San Raffaele - Chirurgia Gastroenterologica
🇮🇹Milano, MI, Italy
Istituto Europeo di Oncologia
🇮🇹Milano, MI, Italy
ASST Grande Ospedale Metropolitano Niguarda
🇮🇹Milano, MI, Italy
Policlinico Abano
🇮🇹Abano Terme, PD, Italy
Azienda Ospedaliero-Universitaria di Parma
🇮🇹Parma, Italy