Clinical trial NCT04219332: Randomized Controlled Trial on Effect of Lymph Node Mapping by Indocyanine Green Via Submucosal or Subserosal Injection
Official title: Comparison of Submucosal and Subserosal Approaches Toward Optimized Indocyanine Green Tracer-Guided Laparoscopic Lymphadenectomy for Patients With Gastric Cancer: The FUGES-019 Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Indocyanine Green
Gastric Cancer
Injection Site
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 266
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to evaluate whether submucosal or subserous injection of indocyanine green during laparoscopic lymphadenectomy for patients with gastric cancer was different. The patients with gastric adenocarcinoma (cT1-4a, N0/+, M0) were studied.

Detailed description: In recent years, with the successful application of ICG (indocyanine green) fluorescence imaging technology in laparoscopic equipment, scholars have found that ICG near-infrared imaging has better tissue penetration and can better identify lymph nodes in hypertrophic adipose tissue than other dyes under visible light, which makes ICG fluorescence imaging guide laparoscopic radical resection of gastric cancer lymph node dissection has become a new exploration direction. ICG near-infrared imaging technology has important research value, good application prospects, and broad development space in laparoscopic radical resection of gastric cancer. However, at present, the application of ICG near-infrared imaging technology in laparoscopic radical resection of gastric cancer is still in the exploratory stage, and there is no unified standard. Therefore, in the world, there is still a lack of high-level evidence-based evidence of large-sample prospective randomized controlled trials to evaluate the effectiveness, safety, and feasibility of submucosal or subserous injection of ICG in guiding laparoscopic D2 resection of gastric cancer. The investigator first carried out this study in the world to evaluate the lymph node dissection and perioperative safety of gastric cancer patients who received a submucosal injection of ICG and subserous injection of ICG during laparoscopic radical gastrectomy in the same period, to promote the standardized development of ICG near-infrared imaging in laparoscopic radical gastrectomy.

Eligibility criteria: 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. Clinical stage tumor T1-4a (cT1-4a), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound
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 Eastern Cooperative Oncology Group scale (ECOG)
6. American Society of Anesthesiology score (ASA) class I, II, or 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 laparoscopic cholecystectomy)
4. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection
5. Rejection of laparoscopic resection
6. History of allergy to iodine agents
7. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
8. History of other malignant disease within past five years
9. History of previous neoadjuvant chemotherapy or radiotherapy
10. History of unstable angina or myocardial infarction within past six months
11. History of cerebrovascular accident within past six months
12. History of continuous systematic administration of corticosteroids within one month
13. Requirement of simultaneous surgery for other disease
14. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
15. Forced expiratory volume in 1 second (FEV1)\<50% of predicted values
16. Linitis plastica, Widespread

Primary outcomes:
measure: Total Number of Retrieved Lymph Nodes
timeFrame: One month after surgery
Secondary outcomes:
measure: Total number of fluorescent lymph nodes in groups A and B
timeFrame: One month after surgery
measure: Relationship between fluorescent lymph nodes and positive lymph nodes in groups A and B (true positive rate)
timeFrame: One month after surgery
measure: Relationship between fluorescent lymph nodes and negative lymph nodes in groups A and B (false positive rate)
timeFrame: One month after surgery
measure: Relationship between non-fluorescent and negative lymph nodes in groups A and B (true negative rate)
timeFrame: One month after surgery
measure: Relationship between non-fluorescent lymph nodes and positive lymph nodes in groups A and B (false negative rate)
timeFrame: One month after surgery
measure: Number of Metastasis Lymph Nodes
timeFrame: One month after surgery
measure: Metastasis rate of lymph node
timeFrame: One month after surgery
measure: Mortality rates
timeFrame: 30 days
measure: Morbidity rates
timeFrame: 30 days
measure: 3-year disease free survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: Time to first ambulation
timeFrame: 30 days
measure: Time to first flatus
timeFrame: 30 days
measure: Time to first liquid diet
timeFrame: 30 days
measure: Time to first soft diet
timeFrame: 30 days
measure: Duration of postoperative hospital stay
timeFrame: 30 days
measure: The variation of weight
timeFrame: 3, 6, 9 and 12 months
measure: The variation of BMI in kg/m^2
timeFrame: 3, 6, 9 and 12 months
measure: Intraoperative morbidity rates
timeFrame: 1 day
measure: The variation of white blood cell count
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: The variation of hemoglobin
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: The variation of C-reactive protein
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: Lymph node noncompliance rate
timeFrame: 1 day
measure: Modified EORTC cancer in-patient satisfaction with care measure (EORTC IN-PATSAT14)
timeFrame: 30 days
measure: The Surgery Task Load Index (SURG-TLX)
timeFrame: 1 day
measure: 3-year overall survival rate
timeFrame: 36 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Department of Gastric Surgery
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Chang-Ming Huang, MD
role: STUDY_CHAIR
References:
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