Clinical trial NCT03050879: Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection
Official title: Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stomach Neoplasms
Indocyanine Green
Keywords: Stomach Neoplasms
Indocyanine Green Tracer
Laparoscopic Gastrectomy
Lymph Node Dissection
Lead sponsor: Fujian Medical University
Sponsor class: OTHER
First posted: 2017-02-13
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 is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma（cT1-4a, N-/+, M0）.

Detailed description: Indocyanine Green Tracer is often applied in surgery for early gastric adenocarcinoma. Its application in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma 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 gastric adenocarcinoma.

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.

Eligibility criteria: Inclusion Criteria:

* Age from 18 to 75 years
* 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:

* Women during pregnancy or breast-feeding
* 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

Primary outcomes:
measure: Total Number of Retrieved Lymph Nodes
timeFrame: 14 days
Secondary outcomes:
measure: The rate of fluorescence
timeFrame: 14 days
measure: Positive rate
timeFrame: 14 days
measure: False positive rate
timeFrame: 14 days
measure: Negative rate
timeFrame: 14 days
measure: False negative rate
timeFrame: 14 days
measure: Number of Metastasis Lymph Nodes
timeFrame: 14 days
measure: Metastasis rate of lymph node
timeFrame: 14 days
measure: Morbidity and mortality rates
timeFrame: 30 days
measure: 3-year disease free survival rate
timeFrame: 36 months
measure: 3-year recurrence pattern
timeFrame: 36 months
measure: Postoperative recovery course
timeFrame: 10 days
measure: Operation time
timeFrame: 1 day
measure: The variation of weight
timeFrame: 3, 6, 9 and 12 months
measure: Intraoperative blood loss
timeFrame: 1 day
measure: Conversive rate
timeFrame: 1 day
measure: Intraoperative morbidity rates
timeFrame: 1 day
measure: Incision length
timeFrame: 1 day
measure: The variation of cholesterol
timeFrame: 3, 6, 9 and 12 months
measure: The variation of album
timeFrame: 3, 6, 9 and 12 months
measure: The results of endoscopy
timeFrame: 3, 6, 9 and 12 months
measure: The variation of body temperature
timeFrame: 8 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
measure: The variation of prealbumin
timeFrame: Preoperative 3 days and postoperative 1, 3, and 5 days
measure: 3-year overall survival rate
timeFrame: 36 months
measure: 5-year overall survival rate
timeFrame: 60 months
measure: 5-year disease free survival rate
timeFrame: 60 months
measure: 5-year recurrence pattern
timeFrame: 60 months
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Medical University Union Hospital
state: Fujian
Study officials:
affiliation: Fujian Medical University Union Hospital
name: Changming Huang, Professor
role: STUDY_CHAIR
References:
citation: 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.