Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer

Gastric Cancer Clinical Trial

— POLA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05720598
• Other study ID #: POLA
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: November 4, 2024

Study information

• Verified date: January 2023
• Source: Medical University of Lublin
• Contact: Karol Rawicz-Pruszynski, MD,PhD
• Phone: +48881318964
• Email: karolrawiczpruszynski[@]umlub.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: November 4, 2024
• Est. primary completion date: November 4, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric Cancer
• Lymph Node Metastasis
• Lymphatic Metastasis
• Stomach Neoplasms

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Poland	Medical University of Lublin	Lublin

Sponsors (3)

Lead Sponsor	Collaborator
Medical University of Lublin	Erasmus Medical Center, Ohio State University

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary endpoint of this study is the identification rate of ICG-guided SN in advanced GC patients.	The identification rate will allow confirmation of the safety and feasibility of ICG-guided SN biopsy during staging laparosocpy in advanced GC patients	Up to 2 weeks after inclusion in the study, during staging laparoscopy
Secondary	Pathological status of the retrieved sentinel node	SN retrieved during staging laparoscopy will undergo microscopic evaluation. The histopathological report will contain information on the character of the lymph node (benign/metastatic)	Up to 2 weeks after staging laparoscopy
Secondary	Pathological status and regression grade of the retrieved sentinel node after neoadjuvant chemotherapy	SN retrieved during gastrectomy will undergo microscopic evaluation. The histopathological report will contain information on the character of the lymph node (benign/metastatic) and its regression grade according to Becker classification	Up to 2 weeks after gastrectomy, 1 month after completion of neoadjuvant chemotherapy and 3 months after initial staging laparoscopy