Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer

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.

Conditions

• Gastric Cancer
• Lymph 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.

Sponsors & Collaborators

• Ohio State University

  collaborator OTHER

• Erasmus Medical Center

  collaborator OTHER

• Medical University of Lublin

  lead OTHER

Principal Investigators

• Karol Rawicz-Pruszyński, MD,PhD · Department of Surgical Oncology, Medical University of Lublin, Poland

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

90 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-11-04

Primary Completion

2024-11-04

Completion

2024-11-04

Countries

• Poland

Study Locations