Clinical trial NCT05720598: Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer
Official title: Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer - POLA Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gastric Cancer
Lymph Node Metastasis
Keywords: Gastric Cancer
ICG
Staging Laparoscopy
Lead sponsor: Medical University of Lublin
Sponsor class: OTHER
Collaborators: name: Ohio State University
name: Erasmus Medical Center
First posted: 2023-02-09
Enrollment: 190
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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

Brief 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.

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

Primary outcomes:
measure: The primary endpoint of this study is the identification rate of ICG-guided SN in advanced GC patients.
timeFrame: Up to 2 weeks after inclusion in the study, during staging laparoscopy
Secondary outcomes:
measure: Pathological status of the retrieved sentinel node
timeFrame: Up to 2 weeks after staging laparoscopy
measure: Pathological status and regression grade of the retrieved sentinel node after neoadjuvant chemotherapy
timeFrame: Up to 2 weeks after gastrectomy, 1 month after completion of neoadjuvant chemotherapy and 3 months after initial staging laparoscopy
Other outcomes:
Locations:
city: Lublin
country: Poland
facility: Medical University of Lublin
Study officials:
affiliation: Department of Surgical Oncology, Medical University of Lublin, Poland
name: Karol Rawicz-Pruszyński, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: