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

Gastric Cancer Clinical Trial

— PhotoNodes  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06466902
• Other study ID #: 649/2022/OSS/AOUPR
• Status: Recruiting
• Start date: December 22, 2022
• Est. completion date: December 2027

Study information

• Verified date: June 2024
• Source: Azienda Ospedaliero-Universitaria di Parma
• Contact: Federico Marchesi, Prof
• Phone: +39 0521 702870
• Email: federico.marchesi[@]unipr.it
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 326
• Est. completion date: December 2027
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Gastrectomy for Gastric Cancer
• Gastric Adenocarcinoma
• Gastric Cancer
• Laparoscopic Surgery
• Lymphadenectomy
• Minimally Invasive Surgery
• Quality Of Care
• Robotic Surgery
• Stomach Neoplasms
• Survival Analysis
• Survival Outcomes

Intervention

Other:
• 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. The PNS for each patient will originate from the average score among the three reviewers.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero-Universitaria di Parma	Parma

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria di Parma

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Correlation between PhotoNode Score and number of harvested lymph nodes.	Any correlation between PNS and number of harvested lymph nodes will also be analyzed	8 weeks after the end of enrollment period
Primary	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.	At the end of enrollment period
Secondary	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.	Data for follow up will be extracted through a 6-monthly medical chart review until 3 years after the end of enrollment period