Actively Recruiting

Age: 18Years +
All Genders
NCT06466902

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

Led by Azienda Ospedaliero-Universitaria di Parma · Updated on 2024-07-05

326

Participants Needed

8

Research Sites

257 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official 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

Eligible

You may qualify if you...

  • Patients undergoing minimally invasive curative-intent surgery for gastric adenocarcinoma with D2 lymphadenectomy
  • Patients treated with upfront surgery or neoadjuvant/perioperative chemotherapy
  • Undergoing total or subtotal gastrectomy
  • Surgery performed using laparoscopic or robotic methods
Not Eligible

You will not qualify if you...

  • Younger than 18 years old
  • Cancer located at esophago-gastric junction Siewert type I, II, or III
  • Presence of metastatic disease
  • Lymphadenectomy less than D2 extent
  • Open surgery or conversion to open surgery
  • Palliative gastrectomy
  • R1 or R2 surgical resection margins
  • Multivisceral resection except cholecystectomy
  • Surgical procedures other than subtotal or total gastrectomy
  • Any single lymph node station rated unevaluable by more than one reviewer

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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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

CONTACT

G

Giorgio Dalmonte, MD, PhD

CONTACT

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