Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection
NCT ID: NCT03050879
Last Updated: 2025-04-24
Study Results
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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COMPLETED
PHASE2
266 participants
INTERVENTIONAL
2017-10-15
2019-07-13
Brief Summary
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Detailed Description
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On the basis of more than 3000 cases of laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma, we want to apply the Indocyanine Green Tracer, a cheap, easy to operate and no radiation pollution way, to predict the positive lymph nodes in gastric adenocarcinoma, to guid the scope of laparoscopic lymph node dissection for gastric adenocarcinoma.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Indocyanine Green Tracer
Indocyanine Green Tracer will be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
Indocyanine Green Tracer
Laparoscopic gastrectomy with lymph node dissection for gastric cancer using Indocyanine Green Tracer
No Indocyanine Green Tracer
Indocyanine Green Tracer will not be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
Indocyanine Green Tracer
Laparoscopic gastrectomy with lymph node dissection for gastric cancer using Indocyanine Green Tracer
Interventions
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Indocyanine Green Tracer
Laparoscopic gastrectomy with lymph node dissection for gastric cancer using Indocyanine Green Tracer
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Fujian Medical University
OTHER
Responsible Party
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Chang-Ming Huang, Prof.
Clinical Professor
Principal Investigators
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Changming Huang, Professor
Role: STUDY_CHAIR
Fujian Medical University Union Hospital
Locations
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Fujian Medical University Union Hospital
Fuzhou, Fujian, China
Countries
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References
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Zhong 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.
Chen 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.
Huang 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.
Chen 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.
Other Identifiers
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FUGES-012
Identifier Type: -
Identifier Source: org_study_id
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