GASTRIC CANCERGastri-ICGNCT06892392
Application of Indocyanine Green Tracer in D2 Lymphadenectomy of Locally Advanced Gastric Cancer
A study testing ICG administration in people with GASTRIC CANCER and Indocyanine Green (ICG), run by Hospital of Navarra at 1 site in Spain.
Trial summary
Gastric cancer is a frequent neoplasm in the world, presenting more than one million new cases and around 768,000 deaths in the data registered in 2020. Among the therapeutic options for gastric cancer, surgery is an essential pillar for its treatment. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- GASTRIC CANCER, Indocyanine Green (ICG), Lymph Node Excision
- What is being tested?
- ICG administration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2026to Dec 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T2-T4a, N+, M0 on preoperative study
- PS 0-1
- ASA I-III
- Laparoscopic surgery
Who cannot join
- - Previous gastric abdominal surgery
- DSE
- Cognitive impairment
- Allergic to iodine
- Synchronous neoplasm
- Stroke in the last 6 months
Show all 9Show fewer
- Angina or AMI in the last 6 months
- Plastic lymphitis
- Open surgery
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Universitario de Navarra
Pamplona, Navarre, 310013
Eguaras Inés, MD, PhD, 0034666909487, ineseguaras@hotmail.com
About this study
Official title: Aplicación Del ICG En La Linfadenectomía D2 Laparoscópica Del Cáncer Gástrico Localmente Avanzado: Ensayo Clínico Aleatorizado Multicéntrico.
Gastric cancer is a frequent neoplasm in the world, presenting more than one million new cases and around 768,000 deaths in the data registered in 2020. Among the therapeutic options for gastric cancer, surgery is an essential pillar for its treatment. Gastric cancer surgery consists of gastric resection with negative margins and radical lymphadenectomy in patients without distant metastases. It has been demonstrated over the years that radical lymphadenectomy in gastric cancer allows for adequate staging and improved long-term survival.
In order to perform a correct staging using the TNM system, it is necessary to resect at least 15 lymph nodes in the radical lymphadenectomy. For radical lymphadenectomy staging, the Japanese Gastric Cancer Association defined and subdivided nodal stations. Three types of lymphadenectomy are described according to oncologic gastric resections (D1, D1+ and D2), with D2 lymphadenectomy being the standard of treatment for locally advanced gastric tumors. Performing an insufficient or inadequate lymphadenectomy has been shown to negatively impact survival after gastrectomy in such a cohort.
Read more
The development of technology based on fluorescence guided by indocyanine green could improve the technique and results of D2 lymphadenectomy in patients with gastric cancer. There is evidence that the application of ICG in D2 lymphadenectomy increases the number of resected nodes, however, studies of higher scientific quality (randomized clinical trials) are needed. Furthermore, most studies in this field have focused on Eastern countries (Japan, Korea and China), where the percentage of early tumors and chemotherapy treatment is different from Western centers.
Therefore, we propose a multicenter randomized clinical trial aimed at evaluating whether the application of ICG-guided fluorescence-based technology in D2 lymphadenectomy of locally advanced gastric cancer increases the number of resected nodes, improves the oncologic quality of the lymphadenectomy, and thus may increase overall survival and disease-free survival at 2 and 5 years postoperatively.
Read the detailed description
Objective:
- Mean total number of nodes/ nodal ratio (number of positive nodes divided by the number of total nodes).
Secondary objective:
- Overall Survival and disease- free survival at 2 and 5 years.
- Number of metastatic nodes
- Complications measured with the Comprehensive Complication Index (CCI)
- Intraoperative bleeding volume
- Surgical time (minutes)
- Days of hospitalization (days) Randomized clinical trial 1:1. The patient will be included once the perioperative chemotherapy treatment is completed. The investigator at each center will explain the study, and if the patient consents to participate, he/she will sign the informed consent form (IC). After which, the investigator of each center will contact the principal investigator of the University Hospital of Navarra (HUN), who will perform the randomization and communicate the result by email to the participating center.
Requirements for participating centers:
- Esophagogastric Surgery Unit with a volume of 20 patients with gastric neoplasia operated on in one year.
- Use the 4k Rubina Tower of the Karl Storz brand.
Inclusion criteria:
- < 85 years
- T1/T4a, N+, M0 in the preoperative study.
- PS 0-1
- ASA I-III
- Laparoscopic surgery
Exclusion criteria:
- Previous gastric abdominal surgery
- DSE
- Cognitive impairment
- Allergic to iodine
- Synchronous neoplasm
- Stroke in the last 6 months
- Angina or AMI in the last 6 months
- Plastic lymphitis
- Open surgery
ICG administration: For ICG administration, a gastroscopy must be performed by the Digestive Service of each center, with sedation 24 hours before surgery. For this, the lesion is located by gastroscopy, after which it is injected in 4 quadrants in the submucosa, with a total volume of 2 ml.
To prepare the ICG, 0.5 ml (containing 0.625 mg of ICG) is dissolved in 1.25 mg/dl of sterile water.
- Conditions
- GASTRIC CANCER, Indocyanine Green (ICG), Lymph Node Excision, Lymphadenectomy, Laparoscopic Gastrectomy
- Being tested
- ICG administration
- Keywords
- Multicenter randomized 1:1 clinical trial, indocyanine green, Laparoscopic gastrectomy with D2 lymphadenectomy
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICG administrationProcedure or surgery
Also called ICG
For the administration of ICG, it is necessary to perform a gastroscopy by the Digestive Service of each center, with sedation 24 h before surgery. For this, the lesion is located by gastroscopy, after which it is injected in 4 quadrants in the submucosa, with a total volume of 2 ml.
To prepare the ICG, 0.5 ml (containing 0.625 mg of ICG) is dissolved in 1.25 mg/dl of sterile water
| Study group | Role | What they receive |
|---|---|---|
| Control Group, Subtotal/Total gastrectomy with D2 lymphadenectomy LPS ( standar of care) | No intervention | * Tumor localization and assessment of resectability * Omentectomy * Ligation and dissection of the right gastroepiploic vessels at their origin. * Dissection of lymph node group 6 * Opening of the pars flaccida of the lesser omentum. * Dissection and ligation of the pyloric artery at its origin * Dissection of ganglionic group 5 * Dissection and section of the first portion of the duodenum. * Lymphadenectomy D2: 7, 8, 9, 9, 11 p, 12a * Ligation and section of the coronary artery at origin * Group 1 lymphadenectomy * Gastric section with negative margin * Removal of the specimen * Reconstruction according to the usual technique Ex vivo analysis of the specimen in the surgical block. A dissection of the D2 lymphadenectomy lymph node groups will be performed including the following groups according to the Japanese Gastric Cancer Association Classification: - Group 7, 8, 9, 11 p, 12 a. Each lymph node group will be sent in a separate labeled sample bottle to the pathology department. |
| Intervention group: ICG administration | Experimental | ICG administration: For ICG administration, a gastroscopy must be performed by the Digestive Service of each center, with sedation 24 h before surgery. For this, the lesion is located by gastroscopy, after which it is injected in 4 quadrants in the submucosa, with a total volume of 2 ml.
To prepare the ICG, 0.5 ml (containing 0.625 mg of ICG) is dissolved in 1.25 mg/dl of sterile water
Standard Total or Subtotal gastrectomy and D2 lymphadenectomy will be performed. After removal of the specimen, we will use ICG mode and evaluate if there are foci of uptake in the territory of the D2 lymphadenectomy.
- If there are foci of uptake, dissect and resect them. Identified in a separate anatomic pathology jar and labeled with the name of the corresponding anatomic region with ICG Receives: Procedure: ICG administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
total nodes resected
Mean of the total nodes resected in the D2 lymphadenectomy
Measured: 18 months
Nodal ratio
number of positive nodes divided by number of total nodes
Measured: 18 months
Secondary outcomes (8)
Overall Survival
Overall survival at 2 and 5 years
Measured: 2 and 5 years
Disease-free survival
Disease-free survival at 2 and 5 years
Measured: 2 and 5 years
Number of metastatic nodes
Number of metastatic nodes
Measured: 18 months
Comprehensive Complication Index
Comprehensive Complication Index (CCI)
Measured: 30 days after surgery
Intraoperative bleeding volume
Intraoperative bleeding volume (ml)
Measured: 18 months
Surgical time
Surgical time (minutes)
Measured: 18 months
Days of hospitalization
Days of hospitalization
Measured: 18 months
Correlation of positive lymph nodes in anatomical pathology and with ICG uptake
Correlation of positive lymph nodes in anatomical pathology and with ICG uptake
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2025
- Study start1 Mar 2026 (estimated)
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 102 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital of Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ines Eguaras, Hospital of Navarra
- Investigators
- Maria Concepcion Yarnoz, MD, PhD, Study chair, Hospital of Navarra
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892392
- Sponsor's protocol ID
- Hospital Universitario de Nava
- Acronym
- Gastri-ICG
- Status last verified
- Mar 2025
- First submitted
- 10 Mar 2025
- Last updated
- 24 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aplicación Del ICG En La Linfadenectomía D2 Laparoscópica Del Cáncer Gástrico Localmente Avanzado: Ensayo Clínico Aleatorizado Multicéntrico.
- ClinicalTrials.gov ID
- NCT06892392
- Acronym / sponsor ID
- Gastri-ICG / Hospital Universitario de Nava
- Conditions
- GASTRIC CANCER, Indocyanine Green (ICG), Lymph Node Excision, Lymphadenectomy, Laparoscopic Gastrectomy
- Keywords
- Multicenter randomized 1:1 clinical trial, indocyanine green, Laparoscopic gastrectomy with D2 lymphadenectomy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 102 participants (estimated)
- Lead sponsor
- Hospital of NavarraUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 24 Mar 2025 (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.
Gastric cancer is a frequent neoplasm in the world, presenting more than one million new cases and around 768,000 deaths in the data registered in 2020. Among the therapeutic options for gastric cancer, surgery is an essential pillar for its treatment. Gastric cancer surgery consists of gastric resection with negative margins and radical lymphadenectomy in patients without distant metastases. It has been demonstrated over the years that radical lymphadenectomy in gastric cancer allows for adequate staging and improved long-term survival.
In order to perform a correct staging using the TNM system, it is necessary to resect at least 15 lymph nodes in the radical lymphadenectomy. For radical lymphadenectomy staging, the Japanese Gastric Cancer Association defined and subdivided nodal stations. Three types of lymphadenectomy are described according to oncologic gastric resections (D1, D1+ and D2), with D2 lymphadenectomy being the standard of treatment for locally advanced gastric tumors. Performing an insufficient or inadequate lymphadenectomy has been shown to negatively impact survival after gastrectomy in such a cohort.
The development of technology based on fluorescence guided by indocyanine green could improve the technique and results of D2 lymphadenectomy in patients with gastric cancer. There is evidence that the application of ICG in D2 lymphadenectomy increases the number of resected nodes, however, studies of higher scientific quality (randomized clinical trials) are needed. Furthermore, most studies in this field have focused on Eastern countries (Japan, Korea and China), where the percentage of early tumors and chemotherapy treatment is different from Western centers.
Therefore, we propose a multicenter randomized clinical trial aimed at evaluating whether the application of ICG-guided fluorescence-based technology in D2 lymphadenectomy of locally advanced gastric cancer increases the number of resected nodes, improves the oncologic quality of the lymphadenectomy, and thus may increase overall survival and disease-free survival at 2 and 5 years postoperatively.
Detailed description
Objective:
- Mean total number of nodes/ nodal ratio (number of positive nodes divided by the number of total nodes).
Secondary objective:
- Overall Survival and disease- free survival at 2 and 5 years.
- Number of metastatic nodes
- Complications measured with the Comprehensive Complication Index (CCI)
- Intraoperative bleeding volume
- Surgical time (minutes)
- Days of hospitalization (days) Randomized clinical trial 1:1. The patient will be included once the perioperative chemotherapy treatment is completed. The investigator at each center will explain the study, and if the patient consents to participate, he/she will sign the informed consent form (IC). After which, the investigator of each center will contact the principal investigator of the University Hospital of Navarra (HUN), who will perform the randomization and communicate the result by email to the participating center.
Requirements for participating centers:
- Esophagogastric Surgery Unit with a volume of 20 patients with gastric neoplasia operated on in one year.
- Use the 4k Rubina Tower of the Karl Storz brand.
Inclusion criteria:
- < 85 years
- T1/T4a, N+, M0 in the preoperative study.
- PS 0-1
- ASA I-III
- Laparoscopic surgery
Exclusion criteria:
- Previous gastric abdominal surgery
- DSE
- Cognitive impairment
- Allergic to iodine
- Synchronous neoplasm
- Stroke in the last 6 months
- Angina or AMI in the last 6 months
- Plastic lymphitis
- Open surgery
ICG administration: For ICG administration, a gastroscopy must be performed by the Digestive Service of each center, with sedation 24 hours before surgery. For this, the lesion is located by gastroscopy, after which it is injected in 4 quadrants in the submucosa, with a total volume of 2 ml.
To prepare the ICG, 0.5 ml (containing 0.625 mg of ICG) is dissolved in 1.25 mg/dl of sterile water.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group, Subtotal/Total gastrectomy with D2 lymphadenectomy LPS ( standar of care) | No intervention | –* Tumor localization and assessment of resectability * Omentectomy * Ligation and dissection of the right gastroepiploic vessels at their origin. * Dissection of lymph node group 6 * Opening of the pars flaccida of the lesser omentum. * Dissection and ligation of the pyloric artery at its origin * Dissection of ganglionic group 5 * Dissection and section of the first portion of the duodenum. * Lymphadenectomy D2: 7, 8, 9, 9, 11 p, 12a * Ligation and section of the coronary artery at origin * Group 1 lymphadenectomy * Gastric section with negative margin * Removal of the specimen * Reconstruction according to the usual technique Ex vivo analysis of the specimen in the surgical block. A dissection of the D2 lymphadenectomy lymph node groups will be performed including the following groups according to the Japanese Gastric Cancer Association Classification: - Group 7, 8, 9, 11 p, 12 a. Each lymph node group will be sent in a separate labeled sample bottle to the pathology department. |
| Intervention group: ICG administration | Experimental | Procedure: ICG administrationICG administration: For ICG administration, a gastroscopy must be performed by the Digestive Service of each center, with sedation 24 h before surgery. For this, the lesion is located by gastroscopy, after which it is injected in 4 quadrants in the submucosa, with a total volume of 2 ml. To prepare the ICG, 0.5 ml (containing 0.625 mg of ICG) is dissolved in 1.25 mg/dl of sterile water Standard Total or Subtotal gastrectomy and D2 lymphadenectomy will be performed. After removal of the specimen, we will use ICG mode and evaluate if there are foci of uptake in the territory of the D2 lymphadenectomy. - If there are foci of uptake, dissect and resect them. Identified in a separate anatomic pathology jar and labeled with the name of the corresponding anatomic region with ICG |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- T2-T4a, N+, M0 on preoperative study
- PS 0-1
- ASA I-III
- Laparoscopic surgery
Key exclusion criteria (9 listed)
- - Previous gastric abdominal surgery
- DSE
- Cognitive impairment
- Allergic to iodine
- Synchronous neoplasm
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 |
|---|---|---|
| ICG administrationAlso: ICGFor the administration of ICG, it is necessary to perform a gastroscopy by the Digestive Service of each center, with sedation 24 h before surgery. For this, the lesion is located by gastroscopy, after which it is injected in 4 quadrants in the submucosa, with a total volume of 2 ml. To prepare the ICG, 0.5 ml (containing 0.625 mg of ICG) is dissolved in 1.25 mg/dl of sterile water | Procedure or surgery | Intervention group: ICG administration |
Primary outcome
total nodes resected
Time frame: 18 months
Mean of the total nodes resected in the D2 lymphadenectomy
Nodal ratio
Time frame: 18 months
number of positive nodes divided by number of total nodes
8 secondary outcomes
Overall Survival
Time frame: 2 and 5 years
Disease-free survival
Time frame: 2 and 5 years
Number of metastatic nodes
Time frame: 18 months
Comprehensive Complication Index
Time frame: 30 days after surgery
Intraoperative bleeding volume
Time frame: 18 months
Surgical time
Time frame: 18 months
Days of hospitalization
Time frame: 18 months
Correlation of positive lymph nodes in anatomical pathology and with ICG uptake
Time frame: 18 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2025.
- 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.
Maria Concepcion Yarnoz, MD, PhD study chair
Hospital of Navarra
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICG administration in people with GASTRIC CANCER and Indocyanine Green (ICG), run by Hospital of Navarra at 1 site in Spain.
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 4 inclusion and 9 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: opening soon, as of the sponsor's last update on 24 Mar 2025. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Inés Eguaras, MD, PhD (+34666909487, ineseguaras@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total nodes resected (time frame: 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Mar 2025.