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

Last updated: July 3, 2024
Sponsor: Azienda Ospedaliero-Universitaria di Parma
Overall Status: Active - Recruiting

Phase

N/A

Condition

Gastric Cancer

Gastric Ulcers

Digestive System Neoplasms

Treatment

Quality assessment of D2 lymphadenectomy using the PhotoNode Score

Clinical Study ID

NCT06466902
649/2022/OSS/AOUPR
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • All patients undergoing minimally invasive curative-intent surgery for gastricadenocarcinoma with D2 lymphadenectomy

  • Patients undergoing upfront surgery or treated with a neoadjuvant/perioperativechemotherapy

  • Total or Subtotal Gastrectomy

  • Laparoscopic or Robotic approach

Exclusion

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

Study Design

Total Participants: 326
Treatment Group(s): 1
Primary Treatment: Quality assessment of D2 lymphadenectomy using the PhotoNode Score
Phase:
Study Start date:
December 22, 2022
Estimated Completion Date:
December 31, 2027

Connect with a study center

  • Ospedale di Cremona - UOC Chirurgia Generale

    Cremona, CR 26100
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Careggi - Chirurgia dell'Apparato Digerente

    Firenze, FI 50134
    Italy

    Active - Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milano, MI 20162
    Italy

    Active - Recruiting

  • Istituto Europeo di Oncologia

    Milano, MI 20139
    Italy

    Active - Recruiting

  • Ospedale San Raffaele - Chirurgia Gastroenterologica

    Milano, MI 20132
    Italy

    Site Not Available

  • Policlinico Abano

    Abano Terme, PD 35031
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco

    Verona, VR 37124
    Italy

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43100
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.