Fact CheckerSign in

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
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

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Policlinico Abano
Coordinator of this site? Confirm its status
Abano TermeItalyRecruiting
Ospedale di Cremona - UOC Chirurgia Generale
Coordinator of this site? Confirm its status
CremonaItalyRecruiting
Azienda Ospedaliera Universitaria Careggi - Chirurgia dell'Apparato Digerente
Coordinator of this site? Confirm its status
FlorenceItalyRecruiting
Ospedale San Raffaele - Chirurgia Gastroenterologica
Coordinator of this site? Confirm its status
MilanItalyNot yet recruiting
Istituto Europeo di Oncologia
Coordinator of this site? Confirm its status
MilanItalyRecruiting
ASST Grande Ospedale Metropolitano Niguarda
Coordinator of this site? Confirm its status
MilanItalyRecruiting
Azienda Ospedaliero Universitaria di Parma
Coordinator of this site? Confirm its status
ParmaItalyRecruiting
Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco
Coordinator of this site? Confirm its status
VeronaItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.