Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer

Trial Title: Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer

NCT ID: NCT05720598

Condition: Gastric Cancer
Lymph Node Metastasis

Conditions: Official terms:
Stomach Neoplasms
Lymphatic Metastasis

Conditions: Keywords:
Gastric Cancer
ICG
Staging Laparoscopy

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Intervention model description: Patients with histopathologically confirmed, locally advanced adenocarcinoma of the stomach scheduled for staging laparoscopy by the multidisciplinary team will be classified for enrollment into this study.

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Sentinel Node Assessment
Description: 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.
Arm group label: Patients underdoing staging laparoscopy with indocyanine green (ICG)

Intervention type: Procedure
Intervention name: Staging laparoscopy
Description: 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.
Arm group label: Patients underdoing staging laparoscopy with indocyanine green (ICG)

Intervention type: Procedure
Intervention name: Gastroscopy with indocyanine green (ICG) injection
Description: 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.
Arm group label: Patients underdoing staging laparoscopy with indocyanine green (ICG)

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. Age ≥ 18 years 2. Histologically confirmed gastric adenocarcinoma (or undifferentiated carcinoma) 3. Stage II - III disease (cT2-4a, N0-3, M0) based on the pretreatment CT and 8th edition of TNM classification 4. Qualification for SL by the decision of the multidisciplinary tumor board 5. Written informed consent for endoscopy and SL Exclusion Criteria: 1. Early GC (cT1N0-3M0) scheduled for endoscopic treatment by the multidisciplinary tumor board 2. Previous abdominal surgery which could interfere lymphatic basin of the stomach, including previous gastrectomy, endoscopic (sub)mucosal dissection 3. Distant metastasis (cM1) clinically apparent in pretreatment abdominal/pelvic CT 4. Technical inability to perform endoscopic ICG injection or ICG injection beyond the submucosa 5. Visual inability to identify the SN during SL 6. Positive cytology (cyt+) after SL 7. Other malignancies 8. History of allergy to iodine agents

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Medical University of Lublin

Address:
City: Lublin
Zip: 20-080
Country: Poland

Status: Recruiting

Contact:
Last name: Karol RawiczPruszyński, Professor

Phone: 81 531 81 26
Email: karol.rawicz-pruszynski@umlub.pl

Start date: November 4, 2022

Completion date: November 4, 2024

Lead sponsor:
Agency: Medical University of Lublin
Agency class: Other

Collaborator:
Agency: Ohio State University
Agency class: Other

Collaborator:
Agency: Erasmus Medical Center
Agency class: Other

Source: Medical University of Lublin

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05720598