Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastrectomies for Gastric Cancer (PhotoNodes)
NCT ID: NCT06466902
Last Updated: 2024-07-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
326 participants
OBSERVATIONAL
2022-12-22
2027-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Safety and Feasibility of Laparoscopic-assisted Gastrectomy for Advanced Gastric Cancer After Neoadjuvant Chemotherapy
NCT02902575
Laparoscopic Versus Open Gastrectomy With Splenic Hilum Lymph Nodes Dissection
NCT02980861
D2 Versus D1 Gastrectomy of Operable Gastric Cancer
NCT04429841
Clinical Outcomes of Laparoscopic D1 Versus D2 Lymphadenectomy for Elderly Patients With Advanced Gastric Cancer
NCT03290209
The Safe Study of Routine Closure of Mesenteric Defects Versus Non-closure After Radical Gastrectomy
NCT05356156
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Patients undergoing minimally invasive gastrectomy
Patients undergoing minimally invasive gastrectomy with D2 lymphadenectomy for gastric cancer
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 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Patients undergoing upfront surgery or treated with a neoadjuvant/perioperative chemotherapy
* Total or Subtotal Gastrectomy
* Laparoscopic or Robotic approach
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Azienda Ospedaliero-Universitaria di Parma
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Federico Marchesi
Associate Professor of General Surgery - University of Parma
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Giorgio Dalmonte, MD, PhD
Role: STUDY_CHAIR
Azienda Ospedaliero-Universitaria di Parma
Federico Marchesi, Prof.
Role: PRINCIPAL_INVESTIGATOR
Azienda Ospedaliero-Universitaria di Parma
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Ospedale di Cremona - UOC Chirurgia Generale
Cremona, CR, Italy
Azienda Ospedaliera Universitaria Careggi - Chirurgia dell'Apparato Digerente
Florence, FI, Italy
Ospedale San Raffaele - Chirurgia Gastroenterologica
Milan, MI, Italy
Istituto Europeo di Oncologia
Milan, MI, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, Italy
Policlinico Abano
Abano Terme, PD, Italy
Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco
Verona, VR, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, , Italy
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
649/2022/OSS/AOUPR
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.