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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03050879
Recruitment Status : Enrolling by invitation
First Posted : February 13, 2017
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
Chang-Ming Huang, Prof., Fujian Medical University Union Hospital

Study Description
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Brief 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）.

Condition or disease Intervention/treatment Phase
Stomach Neoplasms Indocyanine Green Drug: Indocyanine Green Tracer Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 266 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Gastric Cancer
Actual Study Start Date : October 15, 2017
Actual Primary Completion Date : July 4, 2019
Estimated Study Completion Date : January 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer

Arms and Interventions
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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 Name: 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 Name: ICG


Outcome Measures
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Primary Outcome Measures :
  1. Total Number of Retrieved Lymph Nodes [ Time Frame: 14 days ]
    Compare total number of retrieved lymph nodes in both group.


Secondary Outcome Measures :
  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 ]
  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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03050879


Locations
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China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350000
Sponsors and Collaborators
Fujian Medical University
Investigators
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Study Chair: Changming Huang, Professor Fujian Medical University Union Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Chang-Ming Huang, Prof., Clinical Professor, Fujian Medical University Union Hospital
ClinicalTrials.gov Identifier: NCT03050879    
Other Study ID Numbers: 2017-01
First Posted: February 13, 2017    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang-Ming Huang, Prof., Fujian Medical University Union Hospital:
Stomach Neoplasms
Indocyanine Green Tracer
Laparoscopic Gastrectomy
Lymph Node Dissection
Additional relevant MeSH terms:
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Stomach Neoplasms
Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases