Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer

NAUnknownINTERVENTIONAL
Enrollment

190

Participants

Timeline

Start Date

November 4, 2022

Primary Completion Date

November 4, 2024

Study Completion Date

November 4, 2024

Conditions
Gastric CancerLymph Node Metastasis
Interventions
PROCEDURE

Sentinel Node Assessment

The SN assessment will be conducted similarly to the method proposed by Märkl et al. All LNs will be stored in a -80 °C freezer, immediately after retrieval. Within 1 to 3 days, each LN will be individually measured and weighed. Small LNs (\<5 mm in short diameter) will be bisected, and half of the node will be processed for histological evaluation while the remaining half will be used for OSNA analysis. For intermediate-sized LNs (5-10 mm), a middle slice of about 2 mm thickness will be cut out for the histology, and the remaining parts of the node will be processed by OSNA. In large LNs (\>10 mm), at least two slices will be cut out for histology, and the remaining parts of the node will be analyzed by OSNA.

PROCEDURE

Staging laparoscopy

Pneumoperitoneum (10-12mmHg) will be obtained with Veress needle or 10mm trocar after minilaparotomy. Peritoneal cavity will be thoroughly assessed after insertion of two additional trocars. In cases of macroscopic dissemination, peritoneal cancer index (PCI) will be determined. After switching the optical camera into near-infrared / indocyanine green fluorescence mode, the primary tumor will be visualized, followed by assessment and possible dissection of sentinel lymph node with a high-energy device. The lymph node will be retrieved with a sterile bag, and the area of dissection will be marked with a clip. Trocars will be removed under visual assistance, and the pneumoperitoneum will be released through trocars in order to prevent port-site metastases.

PROCEDURE

Gastroscopy with indocyanine green (ICG) injection

Patients will undergo gastroscopy one day prior to staging laparoscopy. The ICG powder contains 0.125 mg/ml. Two milliliters of ICG (0.125mg/ml) solution is injected in the submucosa with into four peritumoral sites, 0.5 ml for each site.

Trial Locations (1)

20-080

RECRUITING

Medical University of Lublin, Lublin

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Ohio State University

OTHER

collaborator

Erasmus Medical Center

OTHER

lead

Medical University of Lublin

OTHER