Surgical quality and prospective quality control of the D2-gastrectomy for gastric cancer in the multicenter randomized LOGICA-trial.
Cas de Jongh, Lianne Triemstra, Arjen van der Veen...
https://pubmed.ncbi.nlm.nih.gov/37651889Actively Recruiting
Age: 18Years +
All Genders
ID06466902
Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastric Cancer Surgery (PhotoNodes)
Led by Azienda Ospedaliero-Universitaria di Parma · Updated on 2024-07-05
326
Participants Needed
8
Research Sites
156 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a new method to assess the quality of lymph node removal during minimally invasive surgery for gastric cancer. This observational study focuses on the PhotoNodes Score, a tool designed to rate the adequacy of D2 lymphadenectomy by examining intraoperative images taken during surgery. The goal is to find a more reliable way to measure surgical quality that may also predict patient survival. During surgery, five high-quality laparoscopic or robotic images are captured at the end of the lymphadenectomy phase before reconstruction begins. Three surgeons independently review these images and score eight specific lymph node stations from poor to excellent. These scores are averaged to create a total PhotoNodes Score for each patient, reflecting the thoroughness of the lymph node removal. Participants undergo minimally invasive gastrectomy with D2 lymphadenectomy and have their surgical images collected and reviewed. Researchers will measure agreement between observers on the scoring and examine how the score relates to disease-free survival and overall survival at 1 and 3 years. Follow-up includes medical chart reviews every six months for up to three years after enrollment ends, allowing detailed assessment of long-term outcomes and surgical quality.
CONDITIONS
Brief Title
Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastrectomies for Gastric Cancer (PhotoNodes)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients undergoing minimally invasive curative-intent surgery for gastric adenocarcinoma with D2 lymphadenectomy
- Patients undergoing upfront surgery or treated with neoadjuvant or perioperative chemotherapy
- Patients scheduled for total or subtotal gastrectomy
- Surgery performed by laparoscopic or robotic approach
- Adults aged 18 years or older
You will not qualify if you...
- Age less than 18 years
- Esophago-gastric junction cancer Siewert type I, II, or III
- Presence of metastatic disease
- Lymphadenectomy less than D2
- Open surgery or conversion to open surgery
- Palliative gastrectomy
- R1 or R2 tumor resection
- Multivisceral resection except cholecystectomy
- Surgical procedures other than subtotal or total gastrectomy
- Any single lymph node station rated as unevaluable by more than one reviewer
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Surgery
Duration - Surgical procedure day
Participants undergo minimally invasive gastrectomy with D2 lymphadenectomy for gastric cancer. During surgery, intraoperative photographs are taken for quality assessment of the lymphadenectomy.
1 visit (in-person)
Long-term Monitoring
Duration - Up to 3 years after enrollment
Participants' medical records are reviewed every 6 months to monitor disease-free and overall survival for up to 3 years after enrollment ends.
Medical chart reviews every 6 months
Trial Site Locations
Total: 8 locations
1
Ospedale di Cremona - UOC Chirurgia Generale
Cremona, CR, Italy, 26100
Actively Recruiting
2
Azienda Ospedaliera Universitaria Careggi - Chirurgia dell'Apparato Digerente
Florence, FI, Italy, 50134
Actively Recruiting
3
Ospedale San Raffaele - Chirurgia Gastroenterologica
Milan, MI, Italy, 20132
Not Yet Recruiting
4
Istituto Europeo di Oncologia
Milan, MI, Italy, 20139
Actively Recruiting
5
ASST Grande Ospedale Metropolitano Niguarda
Milan, MI, Italy, 20162
Actively Recruiting
6
Policlinico Abano
Abano Terme, PD, Italy, 35031
Actively Recruiting
7
Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco
Verona, VR, Italy, 37124
Actively Recruiting
8
Azienda Ospedaliero-Universitaria di Parma
Parma, Italy, 43100
Actively Recruiting
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Research Team
F
Federico Marchesi, Prof
G
Giorgio Dalmonte, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Surgeon Quality Control and Standardization of D2 Lymphadenectomy for Gastric Cancer: A Prospective Multicenter Observational Study (KLASS-02-QC).
Sang-Uk Han, Hoon Hur, Hyuk-Joon Lee...
https://pubmed.ncbi.nlm.nih.gov/33064386Do all the European surgeons perform the same D2? The need of D2 audit in Europe.
Maria Bencivenga, Giuseppe Verlato, Valentina Mengardo...
https://pubmed.ncbi.nlm.nih.gov/29869322Quality control of lymph node dissection in the Dutch Gastric Cancer Trial.
W O de Steur, H H Hartgrink, J L Dikken...
https://pubmed.ncbi.nlm.nih.gov/26313463D2 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.
M Degiuli, R Reddavid, M Tomatis...
https://pubmed.ncbi.nlm.nih.gov/33887514Surgical treatment of gastric cancer: 15-year follow-up results of the randomised nationwide Dutch D1D2 trial.
Ilfet Songun, Hein Putter, Elma Meershoek-Klein Kranenbarg...
https://pubmed.ncbi.nlm.nih.gov/20409751PhotoNodes Protocol: A Multicenter Prospective Study for the Assessment of Proper Lymphadenectomy in Minimally Invasive Gastric Cancer Surgery Using Intraoperative Photographs.
Federico Marchesi, Marina Valente, Simone Giacopuzzi...
https://pubmed.ncbi.nlm.nih.gov/40262552