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

NCT ID: NCT06945718

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

760 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-05-01

Study Completion Date

2030-05-01

Brief Summary

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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.

Detailed Description

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Conditions

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Gastric Cancer Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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laparoscopic gastrectomy with beyond D2 regional fluorescent lymph node dissection with ICG group

ICG with D2+ group

beyond D2 regional lymph node dissection

Intervention Type PROCEDURE

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

beyond D2 regional lymph node dissection

Intervention Type PROCEDURE

dissect the lymph nodes outside the extent of D2 LN region.

Interventions

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beyond D2 regional lymph node dissection

dissect the lymph nodes outside the extent of D2 LN region.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chang-Ming Huang, Prof.

Chief doctor, phD, FACS

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Chang-Ming Huang, Prof.

Role: PRINCIPAL_INVESTIGATOR

Fujian Medical University Union Hospital

Locations

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Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Mi Lin, phD

Role: CONTACT

13459152658

Hua-Long Zheng, phD

Role: CONTACT

18359190587

Facility Contacts

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Changming Huang, M.D., Ph.D.

Role: primary

+86-133-6591-0253

Other Identifiers

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FUGES-30

Identifier Type: -

Identifier Source: org_study_id

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