Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Indocyanine Green Tracer.
- Who it may be relevant to
- Registry conditions: Gastric Cancer. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
Patients with resectable remnant gastric cancer were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic lymph node dissection for remnant gastric cancer by comparing injection ICG group and non-injection ICG group.
Detailed description
Indocyanine Green Tracer is often applied in surgery for gastric cancer. Its application in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer is at the stage of cases accumulation, method studying and clinical research. There is no prospective studies to identify the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer. On the basis of more than 300 cases of laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer, 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 remnant gastric cancer, to guid the scope of laparoscopic lymph node dissection for remnant gastric cancer.
Interventions
- Drug Indocyanine Green Tracer
Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer
Primary outcome measures
- Total Number of Retrieved Lymph Nodes [Time frame: 30 days]
Secondary outcome measures (12)
- Lymph node noncompliance rate [Time frame: 30 days]
- Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group [Time frame: 30 days]
- Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate) [Time frame: 30 days]
- Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate) [Time frame: 30 days]
- Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate) [Time frame: 30 days]
- Number of Metastasis Lymph Nodes [Time frame: 30 days]
- Metastasis rate of lymph node [Time frame: 30 days]
- Postoperative morbidity rate [Time frame: 30 days]
- Postoperative mortality rate [Time frame: 30 days]
- 3-year overall survival rate [Time frame: 3 years]
- 3-year disease-free survival rate [Time frame: 3 years]
- 3-year recurrence pattern [Time frame: 3 years]
Eligibility criteria
Inclusion criteria
- Age from 18 to 75 years
- Remnant gastric cancer (cT1-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition)
(4) No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby 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
- Women during pregnancy or breast-feeding
- Severe mental disorder
- History of previous upper abdominal surgery (except for laparoscopic cholecystectomy and gastrectomy)
- History of previous gastric surgery (including ESD/EMR for gastric cancer)
- Rejection of laparoscopic resection
- History of allergy to iodine agents
- 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 the past six months
- History of unstable angina or myocardial infarction within past six months
- History of continuous systematic administration of corticosteroids within one month
- Requirement of simultaneous surgery for another disease
- Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
- FEV1<50% of the predicted values
- Linitis plastica, Widespread
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Fujian Medical University Union Hospital — Fuzhou
Identifiers
NCT: NCT05618821 · FUGES-027