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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Ospedaliero-Universitaria di Parma

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Age less than 18 year old

Esophago-gastric junction cancer Siewert type I, II or III

Metastatic disease

Lymphadenectomy less than D2

Trial population

Adult patients undergoing minimally invasive curative-intent surgery for gastric adenocarcinoma with D2 lymphadenectomy at the University Hospital of Parma (Azienda Ospedaliero-Universitaria di Parma, Parma, Italy) and all other hospitals participating in the study

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Quality assessment of D2 lymphadenectomy using the PhotoNode Score

    Other intervention

    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.

Treatment groups

326 Participants
are divided into 1 treatment group
Group A: Patients undergoing minimally invasive gastrectomy1 intervention

Trial outcomes

Primary outcomes

1

PhotoNode Score interobserver agreement

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)

Time frame
At the end of enrollment period

Secondary outcomes

1

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

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.

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

Other outcomes

1

Correlation between PhotoNode Score and number of harvested lymph nodes.

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

Time frame
8 weeks after the end of enrollment period

Sponsors and contacts

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