Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Extended Lymphadenectomy Beyond D2 for Locally Advanced Gastric Cancer (FUGES-30)

Prospective Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With D2 Extra-regional Lymph Node Dissection for Locally Advanced Gastric Cancer (FUGES-30)

Taking patients with locally advanced gastric adenocarcinoma (cT2-4a, N-/+, M0) as the research subjects, to evaluate whether the clinical efficacy of laparoscopic beyond D2 regional lymph node dissection for gastric cancer with indocyanine green tracer is better or not.

Study Overview

• Status: Recruiting
• Conditions: Gastric Cancer; Surgery
• Intervention / Treatment: Procedure: beyond D2 regional lymph node dissection

• Study Type: Observational
• Enrollment (Estimated): 760
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mi Lin, phD; Phone Number: 13459152658; Email: silihuala@qq.com
• Study Contact Backup: Name: Hua-Long Zheng, phD; Phone Number: 18359190587; Email: 291167038@qq.com

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Medical University Union Hospital
      • Contact: Changming Huang, M.D., Ph.D.; Phone Number: +86-133-6591-0253; Email: hcmlr2002@163.com
      • Principal Investigator: Changming Huang, M.D., Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Age from 18 to 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition

Description

Inclusion Criteria:

Age from 18 to 75 years Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale ASA (American Society of Anesthesiology) class I to III Written informed consent

Exclusion Criteria:

Women during pregnancy or breast-feeding Severe mental disorder History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) History of previous gastric surgery (including ESD/EMR for gastric cancer) Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky lymph nodes in D3 region.

Other malignant disease within the past 5 years History of unstable angina or myocardial infarction within past six months History of cerebrovascular accident within past six months History of continuous systematic administration of corticosteroids within one month Requirement for simultaneous surgery for other disease Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer FEV1 (forced expiratory volume in one second)<50% of predicted values Diffuse invasive gastric cancer Tumors preoperatively confirmed to involve the squamocolumnar junction or duodenum History of an iodine allergy Patients who declined laparoscopic surgery

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
laparoscopic gastrectomy with beyond D2 regional fluorescent lymph node dissection with ICG group; ICG with D2+ group	Procedure: beyond D2 regional lymph node dissection; dissect the lymph nodes outside the extent of D2 LN region.
laparoscopic gastrectomy with D2 regional lymph node dissection with ICG group; ICG with D2 group	Procedure: beyond D2 regional lymph node dissection; dissect the lymph nodes outside the extent of D2 LN region.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year disease free survival rate	Disease-free survival is calculated from the day of surgery to the day of recurrence or death	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
3-year overall survival rate	3-year overall survival rate	3 years
3-year recurrence pattern	3-year recurrence pattern	3 years
Total number of retrieved lymph nodes	Total number of retrieved lymph nodes	30 days
Noncompliance rate of lymph node dissection	The LN dissection rate was determined by the number of patients in whom a LN station was harvested divided by the total number of patients who required retrieval at the corresponding LN station. Within the scope of D2 dissection, LN noncompliance was defined as the absence of LNs that should have been resected from > 1 LN station.	30 days
Number of metastatic lymph nodes	Number of metastatic lymph nodes	30 days
Metastasis rate of lymph nodes	Metastasis rate of lymph nodes	30 days
Postoperative complications	Postoperative complications were evaluated within 30 days following surgery. These postoperative complications include gastrointestinal-related complications, incision-related complications, respiratory complications, cardiovascular and cerebrovascular complications, urinary system complications, infection complications, embolism complications, and other complications. The grading of postoperative complications adopts the Clavien-Dindo classification.	30 days
Mortality rates	Patient died during hospitalization.	30 days
Postoperative recovery course	Time to first flatus after surgery, time to first ambulation after surgery, time to first liquid diet after surgery, time to first semi-liquid diet after surgery, length of hospital stay after surgery.	30 days
The incidence of intraoperative complications	Intraoperative complications were defined as bleeding due to named vessel injury, injury to visceral organs, mechanical factor-related problems, cardiopulmonary dysfunction due to hypercapnia, and other complications	30 days
Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A	Relationship between the number of fluorescent lymph nodes in group A and total number of lymph nodes in group A	30 days
Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)	The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (True positive rate).	30 days
Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)	The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (false positive rate).	30 days
Relationship between non-fluorescent lymph nodes in Group A and negative lymph nodes in group A (negative rate)	The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in group A (True negative rate).	30 days
Relationship between nonfluorescent lymph nodes in Group A and positive lymph nodes in Group A (false negative rate)	The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in Group A (false negative rate).	30 days
Relationship between fluorescent lymph nodes in group B and total number of lymph nodes in group B	Relationship between the number of fluorescent lymph nodes in group B and total number of lymph nodes in group B	30 days
Relationship between fluorescent lymph nodes in Group B and positive lymph nodes in Group B (positive rate)	The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group B (True positive rate).	30 days
Relationship between fluorescent lymph nodes in Group B and negative lymph nodes in Group B (false positive rate)	The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in Group A (false positive rate).	30 days
Relationship between non-fluorescent lymph nodes in Group B and negative lymph nodes in group B (negative rate)	The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in group B (True negative rate).	30 days
Relationship between nonfluorescent lymph nodes in Group B and positive lymph nodes in Group B (false negative rate)	The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in Group B (false negative rate).	30 days
Inflammatory and immune response	the values of hemoglobin, prealbumin, albumin, C-reactive protein, and white blood cell count from peripheral blood before the operation and on postoperative day 1, 3, 5 are recorded.	7 days

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Investigators: Principal Investigator: Chang-Ming Huang, Prof., Fujian Medical University Union Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2030

Study Registration Dates

• First Submitted: March 21, 2025
• First Submitted That Met QC Criteria: April 20, 2025
• First Posted (Actual): April 25, 2025

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Gastric Cancer; Indocyanine Green Tracer; Laparoscopic Gastrectomy
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: FUGES-30

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No