Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection (ICGTinLG)

Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Gastric Cancer

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）.

Study Overview

• Status: Completed
• Conditions: Stomach Neoplasms; Indocyanine Green
• Intervention / Treatment: Drug: Indocyanine Green Tracer

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.

• Study Type: Interventional
• Enrollment (Actual): 266
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350000
      • Fujian Medical University Union Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Indocyanine Green Tracer; Indocyanine Green Tracer will be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.	Drug: Indocyanine Green Tracer; Laparoscopic gastrectomy with lymph node dissection for gastric cancer using Indocyanine Green Tracer; Other Names: ICG
Active Comparator: No Indocyanine Green Tracer; Indocyanine Green Tracer will not be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.	Drug: Indocyanine Green Tracer; Laparoscopic gastrectomy with lymph node dissection for gastric cancer using Indocyanine Green Tracer; Other Names: ICG

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Number of Retrieved Lymph Nodes	Compare total number of retrieved lymph nodes in both group.	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
Number of Metastasis Lymph Nodes	Compare number of positive lymph nodes in both group.	14 days
Metastasis rate of lymph node	Compare metastasis rate of lymph node in both group	14 days
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
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
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
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
Operation time		1 day
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
Intraoperative blood loss		1 day
Conversive rate		1 day
Intraoperative morbidity rates	The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.	1 day
Incision length		1 day
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
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
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
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
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
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
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
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
3-year overall survival rate	Overall survival was defined as the time from surgery to death from any cause	36 months

Collaborators and Investigators

• Sponsor: Fujian Medical University
• Investigators: Study Chair: Changming Huang, Professor, Fujian Medical University Union Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2017
• Primary Completion (Actual): July 13, 2019
• Study Completion (Actual): July 13, 2019

Study Registration Dates

• First Submitted: January 13, 2017
• First Submitted That Met QC Criteria: February 8, 2017
• First Posted (Actual): February 13, 2017

Study Record Updates

• Last Update Posted (Actual): June 3, 2022
• Last Update Submitted That Met QC Criteria: June 1, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: Stomach Neoplasms; Indocyanine Green Tracer; Laparoscopic Gastrectomy; Lymph Node Dissection
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Stomach Diseases; Stomach Neoplasms
• Other Study ID Numbers: FUGES-012

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No