NCT06466902Recruiting
Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastrectomies for Gastric Cancer (PhotoNodes)
Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastric Cancer Surgery (PhotoNodes)
Source: ClinicalTrials.gov · Last updated 5 Jul 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 326 (estimated)
- First submitted
- 14 Jun 2024
- Start date
- Dec 2022
- Primary completion date
- Dec 2024
- Lead sponsor
- Azienda Ospedaliero-Universitaria di Parma
- Diseases
- Gastric and esophageal cancer
- NCT number
- NCT06466902
What you commit to
- Study type: Observational
- Planned participants: 326
- From Dec 2022 to the primary completion date, Dec 2024
- 8 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Open surgery
- Conversion to open surgery
- R1 or R2 resection
- Multivisceral resection except for cholecystectomy
- Surgical procedures other than subtotal or total gastrectomy
Other illness
- Esophago-gastric junction cancer Siewert type I, II or III
- Metastatic disease
Age
- Age less than 18 year old
Other
- Lymphadenectomy less than D2
- Palliative gastrectomy
- A single node station rated as unevaluable by more than one reviewer
Who the study is looking for
- 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 in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Policlinico Abano Coordinator of this site? Confirm its status | Abano Terme | Italy | Recruiting |
| Ospedale di Cremona - UOC Chirurgia Generale Coordinator of this site? Confirm its status | Cremona | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Careggi - Chirurgia dell'Apparato Digerente Coordinator of this site? Confirm its status | Florence | Italy | Recruiting |
| Ospedale San Raffaele - Chirurgia Gastroenterologica Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Istituto Europeo di Oncologia Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| ASST Grande Ospedale Metropolitano Niguarda Coordinator of this site? Confirm its status | Milan | Italy | Recruiting |
| Azienda Ospedaliero Universitaria di Parma Coordinator of this site? Confirm its status | Parma | Italy | Recruiting |
| Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco Coordinator of this site? Confirm its status | Verona | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.