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

June 14, 2024 updated by: Federico Marchesi, Azienda Ospedaliero-Universitaria di Parma

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

326

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Parma, Italy, 43100
        • Recruiting
        • Azienda Ospedaliero-Universitaria di Parma
        • Contact:
        • Sub-Investigator:
          • Giorgio Dalmonte, MD, PhD
        • Sub-Investigator:
          • Marina Valente, MD
        • Principal Investigator:
          • Federico Marchesi, Prof.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients undergoing minimally invasive gastrectomy
Patients undergoing minimally invasive gastrectomy with D2 lymphadenectomy for gastric cancer
Other: Quality assessment of D2 lymphadenectomy using the PhotoNode Score

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. The PNS for each patient will originate from the average score among the three reviewers.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of enrollment period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Data for follow up will be extracted through a 6-monthly medical chart review until 3 years after the end of enrollment period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
8 weeks after the end of enrollment period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Azienda Ospedaliero-Universitaria di Parma

Investigators

  • Study Chair: Giorgio Dalmonte, MD, PhD, Azienda Ospedaliero-Universitaria di Parma
  • Principal Investigator: Federico Marchesi, Prof., Azienda Ospedaliero-Universitaria di Parma

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 22, 2022

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 14, 2024

First Submitted That Met QC Criteria

June 14, 2024

First Posted (Actual)

June 20, 2024

Study Record Updates

Last Update Posted (Actual)

June 20, 2024

Last Update Submitted That Met QC Criteria

June 14, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 649/2022/OSS/AOUPR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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