Clinical trial · Interventional
Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer
Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer - POLA Study
NCT05720598CI-TRIAL-00063811POLAunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Lymph Node Metastasis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Gastroscopy with indocyanine green (ICG) injection | Procedure | — | UNRESOLVED |
| Sentinel Node Assessment | Procedure | — | UNRESOLVED |
| Staging laparoscopy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Patients underdoing staging laparoscopy with indocyanine green (ICG)
- description
- Patients will undergo upper GI endoscopy one day before SL will be dissolved in sterile water, resulting in a 0.125mg/ml concentration. 2 milliliters of the solution will be injected into the submucosa of 4 peritumoral sites - 0.5ml for each site. The following day patient will undergo SL Intraoperative application of ICG-enhanced vision will be accomplished with dedicated optical devices. Alternate usage of white light and ICG fluorescence mode will allow precise location and cT stage determination of primary tumor, followed by identification of SN and its corresponding LN station, according to Japanese Gastric Cancer Association guidelines. Identified SN will be retrieved with a high-energy device, and the LN basin will be labeled with a magnetic clip.
- interventionNames
- Procedure: Sentinel Node Assessment
- Procedure: Staging laparoscopy
- Procedure: Gastroscopy with indocyanine green (ICG) injection
Primary outcomes (1)
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDRawicz-Pruszynski K, Sedlak K, Pelc Z, Mlak R, Litwinski J, Manko P, Zinkiewicz K, Pasnik I, Cieszczyk K, Pawlik T, Markl B, Erodotou M, Polkowski WP. Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA)-Study protocol for a single-arm prospective observational multicenter study. PLoS One. 2023 May 19;18(5):e0285758. doi: 10.1371/journal.pone.0285758. eCollection 2023. PMID 37205666