Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection

Stomach Neoplasms Clinical Trial

— ICGTinLG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03050879
• Other study ID #: FUGES-012
• Status: Completed
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Indocyanine Green
• Stomach Neoplasms

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