Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer
NCT ID: NCT05720598
Last Updated: 2023-02-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
190 participants
INTERVENTIONAL
2022-11-04
2024-11-04
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
90 Years
ALL
Yes
Sponsors
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Ohio State University
OTHER
Erasmus Medical Center
OTHER
Medical University of Lublin
OTHER
Responsible Party
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Principal Investigators
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Karol Rawicz-Pruszyński, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Surgical Oncology, Medical University of Lublin, Poland
Locations
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Medical University of Lublin
Lublin, , Poland
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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POLA
Identifier Type: -
Identifier Source: org_study_id
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