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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03050879
Other study ID # FUGES-012
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date October 15, 2017
Est. completion date July 13, 2019

Study information

Verified date June 2022
Source Fujian Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Completed
Enrollment 266
Est. completion date July 13, 2019
Est. primary completion date July 13, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Indocyanine Green Tracer
Laparoscopic gastrectomy with lymph node dissection for gastric cancer using Indocyanine Green Tracer

Locations

Country Name City State
China Fujian Medical University Union Hospital Fuzhou Fujian

Sponsors (1)

Lead Sponsor Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Total Number of Retrieved Lymph Nodes Compare total number of retrieved lymph nodes in both group. 14 days
Secondary The rate of fluorescence The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group 14 days
Secondary Positive rate The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group 14 days
Secondary False positive rate The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group 14 days
Secondary Negative rate The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group 14 days
Secondary False negative rate The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group 14 days
Secondary Number of Metastasis Lymph Nodes Compare number of positive lymph nodes in both group. 14 days
Secondary Metastasis rate of lymph node Compare metastasis rate of lymph node in both group 14 days
Secondary Morbidity and mortality rates This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery. 30 days
Secondary 3-year disease free survival rate disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause 36 months
Secondary 3-year recurrence pattern Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type. 36 months
Secondary Postoperative recovery course Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree. 10 days
Secondary Operation time 1 day
Secondary The variation of weight The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life. 3, 6, 9 and 12 months
Secondary Intraoperative blood loss 1 day
Secondary Conversive rate 1 day
Secondary Intraoperative morbidity rates The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation. 1 day
Secondary Incision length 1 day
Secondary The variation of cholesterol The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life. 3, 6, 9 and 12 months
Secondary The variation of album The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life. 3, 6, 9 and 12 months
Secondary The results of endoscopy The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life. 3, 6, 9 and 12 months
Secondary The variation of body temperature The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response. 8 days
Secondary The variation of white blood cell count The values of white blood cell count from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary The variation of hemoglobin The values of hemoglobin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary The variation of C-reactive protein The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary The variation of prealbumin The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response. Preoperative 3 days and postoperative 1, 3, and 5 days
Secondary 3-year overall survival rate Overall survival was defined as the time from surgery to death from any cause 36 months
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