Gastric CancerPOLANCT05720598
Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer
A study testing Sentinel Node Assessment, Staging laparoscopy and Gastroscopy with indocyanine green (ICG) injection in people with Gastric Cancer and Lymph Node Metastasis, run by Medical University of Lublin at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Lymph Node Metastasis
- What is being tested?
- Sentinel Node Assessment, Staging laparoscopy and Gastroscopy with indocyanine green (ICG) injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 190 participants
- Where
- 1 sitePoland
- Study dates
- 4 Nov 2022to 4 Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site, 1 recruiting
- Recruiting
Medical University of Lublin
Lublin, 20-080
Karol RawiczPruszyński, Professor, 81 531 81 26, karol.rawicz-pruszynski@umlub.pl
About this study
Official title: 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.
Read the 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.
- Conditions
- Gastric Cancer, Lymph Node Metastasis
- Being tested
- Sentinel Node Assessment, Staging laparoscopy, Gastroscopy with indocyanine green (ICG) injection
- Keywords
- Gastric Cancer, ICG, Staging Laparoscopy
- Medical subject headings
- Stomach Neoplasms, Lymphatic Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sentinel Node AssessmentProcedure or surgery
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 laparoscopyProcedure or surgery
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) injectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Sentinel Node Assessment; Procedure: Staging laparoscopy; Procedure: Gastroscopy with indocyanine green (ICG) injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Up to 2 weeks after inclusion in the study, during staging laparoscopy
Secondary outcomes (2)
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)
Measured: Up to 2 weeks after staging laparoscopy
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
Measured: Up to 2 weeks after gastrectomy, 1 month after completion of neoadjuvant chemotherapy and 3 months after initial staging laparoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2023
- Study start4 Nov 2022
- Primary completion4 Nov 2024 (estimated)
- Study completion4 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 190 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Lublin
- Sponsor type
- University, hospital or other
- Collaborators
- Ohio State University, Erasmus Medical Center
- Responsible party
- Sponsor
- Investigators
- Karol Rawicz-Pruszyński, MD,PhD, Principal investigator, Department of Surgical Oncology, Medical University of Lublin, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05720598
- Sponsor's protocol ID
- POLA
- Acronym
- POLA
- Status last verified
- Jan 2023
- First submitted
- 19 Jan 2023
- Last updated
- 9 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37205666
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Staging LaParoscopy to Assess Lymph NOde InvoLvement in Advanced GAstric Cancer - POLA Study
- ClinicalTrials.gov ID
- NCT05720598
- Acronym / sponsor ID
- POLA / POLA
- Conditions
- Gastric Cancer, Lymph Node Metastasis
- Keywords
- Gastric Cancer, ICG, Staging Laparoscopy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 190 participants (estimated)
- Lead sponsor
- Medical University of LublinUniversity, hospital or other
- Collaborators
- Ohio State University, Erasmus Medical Center
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 4 Nov 2024 (estimated)
- Study completion
- 4 Nov 2024 (estimated)
- First posted
- 9 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Patients underdoing staging laparoscopy with indocyanine green (ICG) | Experimental | Procedure: Sentinel Node Assessment, Procedure: Staging laparoscopy, Procedure: Gastroscopy with indocyanine green (ICG) injectionPatients 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sentinel Node AssessmentThe 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 or surgery | Patients underdoing staging laparoscopy with indocyanine green (ICG) |
| Staging laparoscopyPneumoperitoneum (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 or surgery | Patients underdoing staging laparoscopy with indocyanine green (ICG) |
| Gastroscopy with indocyanine green (ICG) injectionPatients 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. | Procedure or surgery | Patients underdoing staging laparoscopy with indocyanine green (ICG) |
Primary outcome
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
2 secondary outcomes
Pathological status of the retrieved sentinel node
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2023.
- Derived from this study: PubMed 37205666Rawicz-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Karol Rawicz-Pruszyński, MD,PhD principal investigator
Department of Surgical Oncology, Medical University of Lublin, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sentinel Node Assessment, Staging laparoscopy and Gastroscopy with indocyanine green (ICG) injection in people with Gastric Cancer and Lymph Node Metastasis, run by Medical University of Lublin at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Karol Rawicz-Pruszyński, MD,PhD (+48881318964, karolrawiczpruszynski@umlub.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05720598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2023.