Clinical trial · Interventional
Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection
Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Gastric Cancer
NCT03050879CI-TRIAL-00088861ICGTinLGcompletedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma(cT1-4a, N-/+, M0).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Indocyanine Green | — | UNRESOLVED | — |
| Stomach Neoplasms | Gastric Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine Green Tracer | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Indocyanine Green Tracer
- description
- Indocyanine Green Tracer will be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
- interventionNames
- Drug: Indocyanine Green Tracer
- type
- ACTIVE_COMPARATOR
- label
- No Indocyanine Green Tracer
- description
- Indocyanine Green Tracer will not be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
- interventionNames
- Drug: Indocyanine Green Tracer
Primary outcomes (1)
- measure
- Total Number of Retrieved Lymph Nodes
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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 * clinical stage tumor 1-4a (cT1-4a), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition * No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations * Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG) * American Society of Anesthesiology score (ASA) class I, II, or III * Written informed consent Exclusion Criteria: * Women during pregnancy or breast-feeding * Severe mental disorder * History of previous upper abdominal surgery (except laparoscopic cholecystectomy) * History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection * Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging * History of other malignant disease within past five years * History of previous neoadjuvant chemotherapy or radiotherapy * 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 of simultaneous surgery for other disease * Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer * FEV1\<50% of predicted values * Diffuse; widespread; plastica
References
Publications (4)
- DERIVEDZhong Q, Wu D, Liu ZY, Shang-Guan ZX, Huang ZN, Zhang ZQ, Qiu TY, Chen JY, Jiang YM, Lin GT, Tang YH, Li P, Xie JW, Lin JX, Zheng CH, Chen QY, Huang CM. Long-term oncological outcomes of indocyanine green fluorescence imaging-guided laparoscopic lymphadenectomy for gastric cancer: 5-year outcomes from the FUGES-012 randomized clinical trial. BMC Med. 2025 Aug 26;23(1):497. doi: 10.1186/s12916-025-04334-1. PMID 40859341
- DERIVEDChen QY, Zhong Q, Liu ZY, Li P, Lin GT, Zheng QL, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Zeng GR, Jiang MC, Wang HG, Huang XB, Xu KX, Li YF, Zheng CH, Xie JW, Huang CM. Indocyanine green fluorescence imaging-guided versus conventional laparoscopic lymphadenectomy for gastric cancer: long-term outcomes of a phase 3 randomised clinical trial. Nat Commun. 2023 Nov 16;14(1):7413. doi: 10.1038/s41467-023-42712-6. PMID 37973806
- DERIVEDHuang ZN, He QC, Qiu WW, Wu J, Zheng CY, Lin GS, Li P, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Zheng CH, Chen QY, Huang CM, Xie JW. OSATS scoring confirms ICG enhancement of performance in laparoscopic radical gastrectomy: a post-hoc analysis of a randomized controlled trial. Int J Surg. 2024 Jan 1;110(1):342-352. doi: 10.1097/JS9.0000000000000830. PMID 37939147
- DERIVEDChen QY, Xie JW, Zhong Q, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng HL, Li P, Zheng CH, Huang CM. Safety and Efficacy of Indocyanine Green Tracer-Guided Lymph Node Dissection During Laparoscopic Radical Gastrectomy in Patients With Gastric Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):300-311. doi: 10.1001/jamasurg.2019.6033. PMID 32101269