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Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer (POLA)

Primary Purpose

Gastric Cancer, Lymph Node Metastasis

Status
Recruiting
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Sentinel Node Assessment
Staging laparoscopy
Gastroscopy with indocyanine green (ICG) injection
Sponsored by
Medical University of Lublin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gastric Cancer focused on measuring Gastric Cancer, ICG, Staging Laparoscopy

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • Medical University of LublinRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients underdoing staging laparoscopy with indocyanine green (ICG)

Arm 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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pathological status of the retrieved sentinel node
SN retrieved during staging laparoscopy will undergo microscopic evaluation. The histopathological report will contain information on the character of the lymph node (benign/metastatic)
Pathological status and regression grade of the retrieved sentinel node after neoadjuvant chemotherapy
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

Full Information

First Posted
January 19, 2023
Last Updated
January 31, 2023
Sponsor
Medical University of Lublin
Collaborators
Ohio State University, Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05720598
Brief Title
Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer
Acronym
POLA
Official Title
Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer - POLA Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 4, 2022 (Actual)
Primary Completion Date
November 4, 2024 (Anticipated)
Study Completion Date
November 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Lublin
Collaborators
Ohio State University, Erasmus Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer, Lymph Node Metastasis
Keywords
Gastric Cancer, ICG, Staging Laparoscopy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
190 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Patients underdoing staging laparoscopy with indocyanine green (ICG)
Arm Type
Experimental
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Sentinel Node Assessment
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Staging laparoscopy
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Gastroscopy with indocyanine green (ICG) injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
The primary endpoint of this study is the identification rate of ICG-guided SN in advanced GC patients.
Description
The identification rate will allow confirmation of the safety and feasibility of ICG-guided SN biopsy during staging laparosocpy in advanced GC patients
Time Frame
Up to 2 weeks after inclusion in the study, during staging laparoscopy
Secondary Outcome Measure Information:
Title
Pathological status of the retrieved sentinel node
Description
SN retrieved during staging laparoscopy will undergo microscopic evaluation. The histopathological report will contain information on the character of the lymph node (benign/metastatic)
Time Frame
Up to 2 weeks after staging laparoscopy
Title
Pathological status and regression grade of the retrieved sentinel node after neoadjuvant chemotherapy
Description
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
Time Frame
Up to 2 weeks after gastrectomy, 1 month after completion of neoadjuvant chemotherapy and 3 months after initial staging laparoscopy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Karol Rawicz-Pruszyński, MD,PhD
Phone
+48881318964
Email
karolrawiczpruszynski@umlub.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Katarzyna Sędłak, MD,PhD
Phone
+48790899226
Email
katarzynasedlak@umlub.pl
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karol Rawicz-Pruszyński, MD,PhD
Organizational Affiliation
Department of Surgical Oncology, Medical University of Lublin, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical University of Lublin
City
Lublin
ZIP/Postal Code
20-080
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Karol RawiczPruszyński, Professor
Phone
81 531 81 26
Email
karol.rawicz-pruszynski@umlub.pl

12. IPD Sharing Statement

Plan to Share IPD
No

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Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer

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