Application of Indocyanine Green Tracer in D2 Lymphadenectomy of Locally Advanced Gastric Cancer

NCT ID: NCT06892392

Last Updated: 2025-03-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-03-01
• Study Completion Date: 2032-12-31

Brief 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. 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.

Conditions

GASTRIC CANCER; Indocyanine Green (ICG); Lymph Node Excision; Lymphadenectomy; Laparoscopic Gastrectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group, Subtotal/Total gastrectomy with D2 lymphadenectomy LPS ( standar of care)

• 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group: ICG administration

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

Group Type: EXPERIMENTAL

ICG administration

Intervention Type: PROCEDURE

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

Interventions

ICG administration

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

Intervention Type: PROCEDURE

Other Intervention Names

ICG

Eligibility Criteria

Inclusion Criteria

• T2-T4a, N+, M0 on 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital of Navarra

OTHER

Sponsor Role: lead

Responsible Party

Ines Eguaras

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maria Concepcion Yarnoz, MD, PhD

Role: STUDY_CHAIR

Hospital of Navarra

Locations

Hospital Universitario de Navarra

Pamplona, Navarre, Spain

Countries

Spain

Central Contacts

Inés Eguaras, MD, PhD

Role: CONTACT

ineseguaras@hotmail.com

+34666909487

Facility Contacts

Eguaras Inés, MD, PhD

Role: primary

ineseguaras@hotmail.com

0034666909487

Other Identifiers

Hospital Universitario de Nava

Identifier Type: -

Identifier Source: org_study_id