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

NCT06892392 | Not Yet Recruiting

• 1 other identifier: Hospital Universitario de Nava
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• total nodes resected

  Mean of the total nodes resected in the D2 lymphadenectomy

  18 months

• Nodal ratio

  number of positive nodes divided by number of total nodes

  18 months

Secondary Outcomes (8)

• Overall Survival

  2 and 5 years

• Disease-free survival

  2 and 5 years

• Number of metastatic nodes

  18 months

• Comprehensive Complication Index

  30 days after surgery

• Intraoperative bleeding volume

  18 months

Study Arms (2)

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

Procedure: ICG administration

Interventions

ICG administration 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

Also known as: ICG

Intervention group: ICG administration

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• T2-T4a, N+, M0 on preoperative study
• PS 0-1
• ASA I-III
• Laparoscopic surgery

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Hospital of Navarra: lead

Study Sites (1)

Hospital Universitario de Navarra

Pamplona, Navarre, 310013, Spain

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Officials

• Maria Concepcion Yarnoz, MD, PhD

  Hospital of Navarra

  STUDY CHAIR

Central Study Contacts

Inés Eguaras, MD, PhD

CONTACT

+34666909487; ineseguaras@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 24, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): December 1, 2032
• Study Completion (Estimated): December 1, 2032
• Last Updated: March 24, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)