Clinical trial NCT04973475: Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer
Official title: Prospective Clinical Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy With Lymph Node Dissection for Early Gastric Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Early Gastric Cancer
Indocyanine Green
Lymph Node Dissection
Keywords: Stomach Neoplasms
Indocyanine Green Tracer
Laparoscopic Distal Gastrectomy
Lymph Node Dissection
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2021-07-22
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study aims to explore the value of indocyanine green (ICG) in laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer.The patients with early gastric adenocarcinoma (cT1, N-/+, M0) will be studied.

Detailed description: After being informed about the study and potential risks, all patients giving written informed consent will receiving injection of indocyanine greenat 8 points around the primary tumor with gastroscope 1 day before surgery. During the operation, laparoscopic gastrectomy and perigastric lymph node dissection were performed under ICG imaging equipment. After the surgical specimens were isolated, under the fluorescent illumination of the ICG imaging equipment, the lymph nodes that showed fluorescence and the lymph nodes that did not show fluorescence were collected from each LN station.

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 (cT1), 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. Tumor located in the lower third of the stomach, expected to receive radical distal gastrectomy
6. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)
7. American Society of Anesthesiology score (ASA) class I, II, or III
8. 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. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
6. History of other malignant disease within past five 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 of simultaneous surgery for other disease
12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
13. Forced expiratory volume in 1 second (FEV1)\<50% of predicted values
14. Rejection of laparoscopic resection
15. Preoperatively confirmed tumors invading the dentate line or duodenum
16. History of allergy to iodine agents
17. Tumor located in the upper third of the stomach, expected to receive radical total gastrectomy

Primary outcomes:
measure: False negative rate
timeFrame: One month after surgery
Secondary outcomes:
measure: True positive rate
timeFrame: One month after surgery
measure: False positive rate
timeFrame: One month after surgery
measure: True negative rate
timeFrame: One month after surgery
measure: Total number of retrieved lymph nodes
timeFrame: One month after surgery
measure: Lymph node noncompliance 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: Morbidity and mortality rates
timeFrame: One month after surgery
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 3-year disease free survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: Intraoperative morbidity rates
timeFrame: 1 day
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 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
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
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