Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer

NCT05720598 | Unknown

• 1 other identifier: POLA
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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.

Conditions

Gastric Cancer; Lymph Node Metastasis

Keywords

Gastric Cancer; ICG; Staging Laparoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Pathological status of the retrieved sentinel node

  Up to 2 weeks after staging laparoscopy

• 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

Study Arms (1)

Patients underdoing staging laparoscopy with indocyanine green (ICG)

EXPERIMENTAL

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.

Procedure: Sentinel Node Assessment; Procedure: Staging laparoscopy; Procedure: Gastroscopy with indocyanine green (ICG) injection

Interventions

Sentinel Node Assessment PROCEDURE

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.

Patients underdoing staging laparoscopy with indocyanine green (ICG)

Staging laparoscopy PROCEDURE

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.

Patients underdoing staging laparoscopy with indocyanine green (ICG)

Gastroscopy with indocyanine green (ICG) injection PROCEDURE

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.

Patients underdoing staging laparoscopy with indocyanine green (ICG)

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Histologically confirmed gastric adenocarcinoma (or undifferentiated carcinoma)
• Stage II - III disease (cT2-4a, N0-3, M0) based on the pretreatment CT and 8th edition of TNM classification
• Qualification for SL by the decision of the multidisciplinary tumor board
• Written informed consent for endoscopy and SL

You may not qualify if:

• Early GC (cT1N0-3M0) scheduled for endoscopic treatment by the multidisciplinary tumor board
• Previous abdominal surgery which could interfere lymphatic basin of the stomach, including previous gastrectomy, endoscopic (sub)mucosal dissection
• Distant metastasis (cM1) clinically apparent in pretreatment abdominal/pelvic CT
• Technical inability to perform endoscopic ICG injection or ICG injection beyond the submucosa
• Visual inability to identify the SN during SL
• Positive cytology (cyt+) after SL
• Other malignancies
• History of allergy to iodine agents

Sponsors & Collaborators

• Medical University of Lublin: lead
• Ohio State University: collaborator
• Erasmus Medical Center: collaborator

Study Sites (1)

Medical University of Lublin

Lublin, 20-080, Poland

RECRUITING

Related Publications (1)

• Rawicz-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 DERIVED

MeSH Terms

Conditions

Stomach Neoplasms; Lymphatic Metastasis

Interventions

Gastroscopy; Indocyanine Green; Injections

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Neoplasm Metastasis; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy, Gastrointestinal; Endoscopy, Digestive System; Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Karol Rawicz-Pruszyński, MD,PhD

  Department of Surgical Oncology, Medical University of Lublin, Poland

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Karol Rawicz-Pruszyński, MD,PhD

CONTACT

+48881318964; karolrawiczpruszynski@umlub.pl

Katarzyna Sędłak, MD,PhD

CONTACT

+48790899226; katarzynasedlak@umlub.pl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 19, 2023
• First Posted: February 9, 2023
• Study Start: November 4, 2022
• Primary Completion: November 4, 2024
• Study Completion: November 4, 2024
• Last Updated: February 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)