Clinical trial · Interventional
Indocyanine Green Tracer Using in Laparoscopic Radical Gastrectomy for Locally Advanced Gastric Cancer
Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy with Lymph Node Dissection for Locally Advanced Gastric Cancer (CLASS-11)
NCT04593615CI-TRIAL-00084201CLASS-11active not recruitingN/AClinicalTrials.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)
Patients with locally advanced gastric adenocarcinoma (CT2-4a N0/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic D2 lymph node dissection for gastric cancer by comparing injection ICG group and non-injection ICG group.
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 |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ICG near-infrared imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group A
- description
- Laparoscopic gastrectomy Group with the use of near-infrared imaging (ICG group)
- interventionNames
- Procedure: ICG near-infrared imaging
- type
- PLACEBO_COMPARATOR
- label
- Group B
- description
- Laparoscopic gastrectomy Group without the use of near-infrared imaging (Non-ICG group)
- interventionNames
- Procedure: ICG near-infrared imaging
Primary outcomes (1)
- measure
- 3-year disease free survival rate
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age from 18 to 75 years 2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy 3. cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition 4. No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations 5. Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale 6. ASA (American Society of Anesthesiology) class I to III 7. Written informed consent Exclusion Criteria: 1. Women during pregnancy or breast-feeding 2. Severe mental disorder 3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy) 4. History of previous gastric surgery (including ESD/EMR for gastric cancer) 5. Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky No.10 lymph nodes 6. Other malignant disease within the past 5 years 7. History of previous neoadjuvant chemotherapy or radiotherapy 8. History of unstable angina or myocardial infarction within past six months 9. History of cerebrovascular accident within past six months 10. History of continuous systematic administration of corticosteroids within one month 11. Requirement for simultaneous surgery for other disease 12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer 13. FEV1 (forced expiratory volume in one second)\<50% of predicted values 14. Diffuse invasive gastric cancer 15. Tumors preoperatively confirmed to involve the squamocolumnar junction or duodenum 16. History of an iodine allergy 17. Patients who declined laparoscopic surgery
References
Publications (1)
- DERIVEDZheng CH, Chen YB, Yu WB, Cai LS, Wang Q, Sun YH, Yan S, He XL, Xu ZK, Li GX, Tian YT, Li C, Wang BG, Ji JF, Xu YC, Zhong Q, Liu ZY, Chen QY, Li P, Xie JW, Liang Y, Liu ZM, Qiu HB, Wei M, Yan ZB, Lv CB, Chen QX, Li S, Zeng LX, Huo BW, Li ZY, Su XQ, Huang CM; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Safety and efficacy of indocyanine green-guided laparoscopic lymphadenectomy for locally advanced gastric cancer: The CLASS-11 clinical trials. Cell Rep Med. 2025 May 20;6(5):102136. doi: 10.1016/j.xcrm.2025.102136. PMID 40398388