Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection

Overview

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).

Full Title of Study: “Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Gastric Cancer”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 13, 2019

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: Indocyanine Green Tracer
    • Indocyanine Green Tracer will be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • The rate of fluorescence
    • Time Frame: 14 days
    • The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group
  • Positive rate
    • Time Frame: 14 days
    • The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
  • False positive rate
    • Time Frame: 14 days
    • The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group
  • Negative rate
    • Time Frame: 14 days
    • 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
  • False negative rate
    • Time Frame: 14 days
    • 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
  • Number of Metastasis Lymph Nodes
    • Time Frame: 14 days
    • Compare number of positive lymph nodes in both group.
  • Metastasis rate of lymph node
    • Time Frame: 14 days
    • Compare metastasis rate of lymph node in both group
  • Morbidity and mortality rates
    • Time Frame: 30 days
    • This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.
  • 3-year disease free survival rate
    • Time Frame: 36 months
  • 3-year recurrence pattern
    • Time Frame: 36 months
    • Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.
  • Postoperative recovery course
    • Time Frame: 10 days
    • 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.
  • Operation time
    • Time Frame: 1 day
  • The variation of weight
    • Time Frame: 3, 6, 9 and 12 months
    • The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.
  • Intraoperative blood loss
    • Time Frame: 1 day
  • Conversive rate
    • Time Frame: 1 day
  • Intraoperative morbidity rates
    • Time Frame: 1 day
    • The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
  • Incision length
    • Time Frame: 1 day
  • The variation of cholesterol
    • Time Frame: 3, 6, 9 and 12 months
    • 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.
  • The variation of album
    • Time Frame: 3, 6, 9 and 12 months
    • 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.
  • The results of endoscopy
    • Time Frame: 3, 6, 9 and 12 months
    • The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.
  • The variation of body temperature
    • Time Frame: 8 days
    • The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.
  • The variation of white blood cell count
    • Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days
    • 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.
  • The variation of hemoglobin
    • Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days
    • 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.
  • The variation of C-reactive protein
    • Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days
    • 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.
  • The variation of prealbumin
    • Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fujian Medical University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Chang-Ming Huang, Prof., Clinical Professor – Fujian Medical University Union Hospital
  • Overall Official(s)
    • Changming Huang, Professor, Study Chair, Fujian Medical University Union Hospital

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