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NCT Number: NCT06466902

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

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.

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Key information

Conditions

Gastric Cancer Digestive System Diseases Digestive System Neoplasms Gastrectomy for Gastric Cancer Gastric Adenocarcinoma Gastrointestinal Diseases Gastrointestinal Neoplasms Laparoscopic Surgery Lymphadenectomy Minimally Invasive Surgery Neoplasms Neoplasms by Site Quality Of Care Robotic Surgery Stomach Diseases Stomach Neoplasms Survival Analysis Survival Outcomes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ospedale di Cremona - UOC Chirurgia Generale, Cremona, CR, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

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

Treatment and study plan

Quality assessment of D2 lymphadenectomy using the PhotoNode Score

Other

During the surgical procedure, a set of 5 high quality laparoscopic intraoperative images of the surgical field will be put on record. Photographs will be taken at the end of the lymphadenectomy phase, before the reconstructive phase begins.

Three surgeons will review the images. Quality of D2 lymphadenectomy will be assessed independently rating eight node stations (1, 5, 6, 7, 8a, 9, 11p and 12a), based upon the evaluation of the 5 images. Each node station will be given a score from 0 to 3, corresponding to a judgment of Unevaluable (0), Poor (1), Doubtful (2) or Excellent (3) lymphadenectomy respectively, in that specific node station.

A total score for each patient will be independently obtained from each reviewer ranging from a minimum of 7 (poor lymphadenectomy) to a maximum of 24 (excellent lymphadenectomy). The PNS for each patient will originate from the average score among the three reviewers.

Primary outcomes

  1. PhotoNode Score interobserver agreement

    Time frame: 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 outcomes

  1. Association between PhotoNode Score and disease-free, 1-year and 3-year overall survival

    Time frame: 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.

Other outcomes

  1. Correlation between PhotoNode Score and number of harvested lymph nodes.

    Time frame: 8 weeks after the end of enrollment period

    Any correlation between PNS and number of harvested lymph nodes will also be analyzed

Study contacts

Contact information is provided by the study sponsor or research team.

Federico Marchesi, Prof

CONTACT

[email protected]

00390521906343

Giorgio Dalmonte, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria di Parma

Other

Registry information

Official study title

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

Acronym: PhotoNodes

Important dates

Study start
2022
Primary completion
2024
Study completion
2027
First posted
Jun 20, 2024
Registry last updated
Jul 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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