NCT05720598

Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer

Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer - POLA Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 190 (estimated)
• Sponsor: Medical University of Lublin · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Accepted

Summary

Staging LaParscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA) study aims to investigate the safety and feasibility of ICG-guided SN retrieval in GC patients undergoing multimodal treatment. The pretreatment clinical variables potentially associated with the procedure will also be analyzed. To the best of our knowledge, the current study is the first to evaluate the role of ICG in SN biopsy in advanced GC patients undergoing multimodal treatment.

Detailed description

Comprehensive lymph node assessment seems to be critical for proper treatment strategy and survival prediction, particularly in advanced GC. Recent data on the sentinel node (SN) concept in early GC has shown favorable results regarding LN detection rate and clinical status determination. Staging laparoscopy (SL) with lavage cytology provides an additional value to the clinical staging of GC, particularly in detecting occult peritoneal disease. The role of Indocyanine green (ICG) guided SN mapping in GC confirmed its technical feasibility. ICG can be safely used to identify SN, determine the surgical resection line, improve the LN harvest, and reduce noncompliance in patients undergoing D2 lymphadenectomy. The majority of the studies focused on the aspect of the increase in LN harvest. At the same time, no data exist regarding its potential role in GC nodal staging. To the best of our knowledge, the current study is the first to evaluate the role of ICG in SN biopsy in advanced GC patients undergoing multimodal treatment.

Conditions

• Gastric Cancer
• Lymph Node Metastasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-11-04
• Primary completion: 2024-11-04
• Completion: 2024-11-04
• First posted: 2023-02-09
• Last updated: 2023-02-09

Locations

1 site across 1 country: Poland