Clinical trial NCT06466902: Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastrectomies for Gastric Cancer (PhotoNodes)
Official title: Evaluation of Intra-operative Photographs for the Assessment of a Proper Lymphadenectomy in Minimally-invasive Gastric Cancer Surgery (PhotoNodes)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric Cancer
Gastric Adenocarcinoma
Lymphadenectomy
Minimally Invasive Surgery
Gastrectomy for Gastric Cancer
Laparoscopic Surgery
Robotic Surgery
Survival Outcomes
Survival Analysis
Quality Of Care
Keywords: D2 Lymphadenectomy quality assessment
Minimally invasive gastric cancer oncologic surgery
Lead sponsor: Azienda Ospedaliero-Universitaria di Parma
Sponsor class: OTHER
First posted: 2024-06-20
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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 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: 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

Primary outcomes:
measure: PhotoNode Score interobserver agreement
timeFrame: At the end of enrollment period
Secondary outcomes:
measure: Association between PhotoNode Score and disease-free, 1-year and 3-year overall survival
timeFrame: 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:
measure: Correlation between PhotoNode Score and number of harvested lymph nodes.
timeFrame: 8 weeks after the end of enrollment period
Locations:
city: Cremona
country: Italy
facility: Ospedale di Cremona - UOC Chirurgia Generale
state: CR
city: Firenze
country: Italy
facility: Azienda Ospedaliera Universitaria Careggi - Chirurgia dell'Apparato Digerente
state: FI
city: Milano
country: Italy
facility: Ospedale San Raffaele - Chirurgia Gastroenterologica
state: MI
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia
state: MI
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
state: MI
city: Abano Terme
country: Italy
facility: Policlinico Abano
state: PD
city: Verona
country: Italy
facility: Azienda Ospedaliera Universitaria Integrata Borgo Trento - Chirurgia Generale ed Esofago Stomaco
state: VR
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
Study officials:
affiliation: Azienda Ospedaliero-Universitaria di Parma
name: Giorgio Dalmonte, MD, PhD
role: STUDY_CHAIR
affiliation: Azienda Ospedaliero-Universitaria di Parma
name: Federico Marchesi, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.