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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Policlinico Abano
RECRUITING
Abano Terme
Ospedale di Cremona - UOC Chirurgia Generale
RECRUITING
Cremona
Azienda Ospedaliera Universitaria Careggi - Chirurgia dell'Apparato Digerente
RECRUITING
Florence
ASST Grande Ospedale Metropolitano Niguarda
RECRUITING
Milan
Istituto Europeo di Oncologia
RECRUITING
Milan
Ospedale San Raffaele - Chirurgia Gastroenterologica
NOT_YET_RECRUITING
Milan
Azienda Ospedaliero-Universitaria di Parma
RECRUITING
Parma
Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco
RECRUITING
Verona
Contact Information
Primary
Federico Marchesi, Prof
federico.marchesi@unipr.it
00390521906343
Backup
Giorgio Dalmonte, MD, PhD
gdalmonte@ao.pr.it
Time Frame
Start Date: 2022-12-22
Estimated Completion Date: 2027-12
Participants
Target number of participants: 326
Treatments
Patients undergoing minimally invasive gastrectomy
Patients undergoing minimally invasive gastrectomy with D2 lymphadenectomy for gastric cancer
Sponsors
Leads: Azienda Ospedaliero-Universitaria di Parma

This content was sourced from clinicaltrials.gov

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