Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer

Not Applicable

Recruiting

• Conditions: Gastric Cancer; Lymph Node Metastasis
• Interventions: Procedure: Sentinel Node Assessment; Procedure: Staging laparoscopy; Procedure: Gastroscopy with indocyanine green (ICG) injection

• Registration Number: NCT05720598
• Lead Sponsor: Medical University of Lublin

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.

Study Timeline

• Study Start: 2022-11-04
• Status Verified: 2023-01
• Study First Submitted: 2023-01-19
• Study First Submitted QC: 2023-01-31
• Last Update Submitted: 2023-01-31
• Study First Posted: 2023-02-09
• Last Update Posted: 2023-02-09
• Primary Completion: 2024-11-04
• Study Completion: 2024-11-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 190

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients underdoing staging laparoscopy with indocyanine green (ICG)	Staging laparoscopy	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.
Patients underdoing staging laparoscopy with indocyanine green (ICG)	Sentinel Node Assessment	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.
Patients underdoing staging laparoscopy with indocyanine green (ICG)	Gastroscopy with indocyanine green (ICG) injection	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.

Primary Outcome Measures

Name	Time	Method
The primary endpoint of this study is the identification rate of ICG-guided SN in advanced GC patients.	Up to 2 weeks after inclusion in the study, during staging laparoscopy	The identification rate will allow confirmation of the safety and feasibility of ICG-guided SN biopsy during staging laparosocpy in advanced GC patients

Secondary Outcome Measures

Name	Time	Method
Pathological status and regression grade of the retrieved sentinel node after neoadjuvant chemotherapy	Up to 2 weeks after gastrectomy, 1 month after completion of neoadjuvant chemotherapy and 3 months after initial staging laparoscopy	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
Pathological status of the retrieved sentinel node	Up to 2 weeks after staging laparoscopy	SN retrieved during staging laparoscopy will undergo microscopic evaluation. The histopathological report will contain information on the character of the lymph node (benign/metastatic)

Trial Locations

Locations (1)

Medical University of Lublin; 🇵🇱 Lublin, Poland