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Completed

NCT Number: NCT03050879

Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection

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）.

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Key information

Conditions

Stomach Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Indocyanine Green Neoplasms Neoplasms by Site Stomach Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Indocyanine Green Tracer

Drug

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

Other names: ICG

Primary outcomes

  1. Total Number of Retrieved Lymph Nodes

    Time frame: 14 days

    Compare total number of retrieved lymph nodes in both group.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Number of Metastasis Lymph Nodes

    Time frame: 14 days

    Compare number of positive lymph nodes in both group.

  7. Metastasis rate of lymph node

    Time frame: 14 days

    Compare metastasis rate of lymph node in both group

  8. 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.

  9. 3-year disease free survival rate

    Time frame: 36 months

    disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause

  10. 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.

  11. 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.

  12. Operation time

    Time frame: 1 day

  13. 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.

  14. Intraoperative blood loss

    Time frame: 1 day

  15. Conversive rate

    Time frame: 1 day

  16. Intraoperative morbidity rates

    Time frame: 1 day

    The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.

  17. Incision length

    Time frame: 1 day

  18. 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.

  19. 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.

  20. 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.

  21. 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.

  22. 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.

  23. 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.

  24. 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.

  25. 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.

  26. 3-year overall survival rate

    Time frame: 36 months

    Overall survival was defined as the time from surgery to death from any cause

  27. 5-year overall survival rate

    Time frame: 60 months

    Overall survival was defined as the time from surgery to death from any cause

  28. 5-year disease free survival rate

    Time frame: 60 months

    disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause

  29. 5-year recurrence pattern

    Time frame: 60 months

    Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

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

Acronym: ICGTinLG

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Feb 13, 2017
Registry last updated
Apr 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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