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

January 31, 2023 updated by: Medical University of Lublin

Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer - POLA Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Anticipated)

190

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients underdoing staging laparoscopy with indocyanine green (ICG)

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
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.
Procedure: Staging laparoscopy
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.
Procedure: Gastroscopy with indocyanine green (ICG) injection
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The primary endpoint of this study is the identification rate of ICG-guided SN in advanced GC patients.
Time Frame: 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
Up to 2 weeks after inclusion in the study, during staging laparoscopy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathological status of the retrieved sentinel node
Time Frame: 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)
Up to 2 weeks after staging laparoscopy
Pathological status and regression grade of the retrieved sentinel node after neoadjuvant chemotherapy
Time Frame: 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
Up to 2 weeks after gastrectomy, 1 month after completion of neoadjuvant chemotherapy and 3 months after initial staging laparoscopy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lublin

Collaborators

Erasmus Medical Center
Ohio State University

Investigators

  • Principal Investigator: Karol Rawicz-Pruszyński, MD,PhD, Department of Surgical Oncology, Medical University of Lublin, Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 4, 2022

Primary Completion (ANTICIPATED)

November 4, 2024

Study Completion (ANTICIPATED)

November 4, 2024

Study Registration Dates

First Submitted

January 19, 2023

First Submitted That Met QC Criteria

January 31, 2023

First Posted (ESTIMATE)

February 9, 2023

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

January 31, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • POLA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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