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Gastric CancerPhotoNodesNCT06466902

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

An observational study of Gastric Cancer and Gastric Adenocarcinoma, run by Azienda Ospedaliero-Universitaria di Parma at 8 sites in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Quality assessment of D2 lymphadenectomy using the PhotoNode Score
How many people
326 participants
Where
8 sitesItaly
Study dates
22 Dec 2022to Dec 2027
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

8 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Federico Marchesi, Prof contact

00390521906343

federico.marchesi@unipr.it

Giorgio Dalmonte, MD, PhD contact

gdalmonte@ao.pr.it

8 sites in 1 country

Italy8 sites, 8 recruiting

  • Policlinico Abano

    Abano Terme, PD, 35031

    Recruiting

  • Ospedale di Cremona - UOC Chirurgia Generale

    Cremona, CR, 26100

    Recruiting

  • Azienda Ospedaliera Universitaria Careggi - Chirurgia dell'Apparato Digerente

    Florence, FI, 50134

    Recruiting

  • Ospedale San Raffaele - Chirurgia Gastroenterologica

    Milan, MI, 20132

    Not yet recruiting

  • Istituto Europeo di Oncologia

    Milan, MI, 20139

    Recruiting

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, MI, 20162

    Recruiting

  • Azienda Ospedaliero-Universitaria di Parma

    Parma, 43100

    Federico Marchesi, Prof., 00390521906343, federico.marchesi@unipr.it

    Giorgio Dalmonte, MD, PhD

    Recruiting

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

    Verona, VR, 37124

    Recruiting

Other trials in Italy

About this study

Official title: 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.

Read more

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.

Being tested
Quality assessment of D2 lymphadenectomy using the PhotoNode Score
Keywords
D2 Lymphadenectomy quality assessment, Minimally invasive gastric cancer oncologic surgery
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quality assessment of D2 lymphadenectomy using the PhotoNode ScoreOther

    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.

Study groups in NCT06466902
Study groupRoleWhat they receive
Patients undergoing minimally invasive gastrectomyPatients undergoing minimally invasive gastrectomy with D2 lymphadenectomy for gastric cancer
Receives: Other: Quality assessment of D2 lymphadenectomy using the PhotoNode Score

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: At the end of enrollment period

Secondary outcomes (1)

  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.

    Measured: Data for follow up will be extracted through a 6-monthly medical chart review until 3 years after the end of enrollment period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2024
  2. Study start22 Dec 2022
  3. Primary completionDec 2024 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
326 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06466902
Sponsor's protocol ID
649/2022/OSS/AOUPR
Acronym
PhotoNodes
Status last verified
Jul 2024
First submitted
14 Jun 2024
Last updated
5 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • de Jongh C, Triemstra L, van der Veen A, Brosens LA, Nieuwenhuijzen GA, Stoot JH, de Steur WO, Ruurda JP, van Hillegersberg R; LOGICA Study Group. Surgical quality and prospective quality control of the D2-gastrectomy for gastric cancer in the multicenter randomized LOGICA-trial. Eur J Surg Oncol. 2023 Oct;49(10):107018. doi: 10.1016/j.ejso.2023.107018. Epub 2023 Aug 12.

    PubMed 37651889

  • Han SU, Hur H, Lee HJ, Cho GS, Kim MC, Park YK, Kim W, Hyung WJ; Korean Laparoendoscopic Gastrointestinal Surgery Study (KLASS) Group. Surgeon Quality Control and Standardization of D2 Lymphadenectomy for Gastric Cancer: A Prospective Multicenter Observational Study (KLASS-02-QC). Ann Surg. 2021 Feb 1;273(2):315-324. doi: 10.1097/SLA.0000000000003883.

    PubMed 33064386

  • Bencivenga M, Verlato G, Mengardo V, Weindelmayer J, Allum WH. Do all the European surgeons perform the same D2? The need of D2 audit in Europe. Updates Surg. 2018 Jun;70(2):189-195. doi: 10.1007/s13304-018-0542-4. Epub 2018 Jun 4.

    PubMed 29869322

  • de Steur WO, Hartgrink HH, Dikken JL, Putter H, van de Velde CJ. Quality control of lymph node dissection in the Dutch Gastric Cancer Trial. Br J Surg. 2015 Oct;102(11):1388-93. doi: 10.1002/bjs.9891. Epub 2015 Aug 27.

    PubMed 26313463

  • Degiuli M, Reddavid R, Tomatis M, Ponti A, Morino M, Sasako M; of the Italian Gastric Cancer Study Group (IGCSG). D2 dissection improves disease-specific survival in advanced gastric cancer patients: 15-year follow-up results of the Italian Gastric Cancer Study Group D1 versus D2 randomised controlled trial. Eur J Cancer. 2021 Jun;150:10-22. doi: 10.1016/j.ejca.2021.03.031. Epub 2021 Apr 19.

    PubMed 33887514

  • Songun I, Putter H, Kranenbarg EM, Sasako M, van de Velde CJ. Surgical treatment of gastric cancer: 15-year follow-up results of the randomised nationwide Dutch D1D2 trial. Lancet Oncol. 2010 May;11(5):439-49. doi: 10.1016/S1470-2045(10)70070-X. Epub 2010 Apr 19.

    PubMed 20409751

  • Marchesi F, Valente M, Giacopuzzi S, Baiocchi GL, Morgagni P, Torroni L, Dalmonte G; Italian Research Group for Gastric Cancer (GIRCG). PhotoNodes Protocol: A Multicenter Prospective Study for the Assessment of Proper Lymphadenectomy in Minimally Invasive Gastric Cancer Surgery Using Intraoperative Photographs. Dig Surg. 2025;42(3):146-151. doi: 10.1159/000545846. Epub 2025 Apr 22.

    PubMed 40262552

Questions about this trial

What is this clinical trial studying?

An observational study of Gastric Cancer and Gastric Adenocarcinoma, run by Azienda Ospedaliero-Universitaria di Parma at 8 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 5 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Federico Marchesi, Prof (00390521906343, federico.marchesi@unipr.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PhotoNode Score interobserver agreement (time frame: At the end of enrollment period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06466902, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2024.

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