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Gastric Cancer
+1

Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer

Sponsored by Medical University of Lublin

About this trial

Last updated 2 years ago

Study ID

POLA

Status

Recruiting

Type

Interventional

Phase

N/A

Placebo

No

Accepting

18-75 Years
18 to 90 Years
All
All

Trial Timing

Ended 8 months ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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

Locations

Location

Status

Recruiting