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Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy for Early Gastric Cancer

Sponsor
Fujian Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04973475
Collaborator
(none)
180
Enrollment
1
Location
1
Arm
60
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to explore the value of indocyanine green (ICG) in laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer.The patients with early gastric adenocarcinoma (cT1, N-/+, M0) will be studied.

Condition or Disease Intervention/Treatment Phase
  • Drug: Indocyanine Green
 Phase 2

Detailed Description

After being informed about the study and potential risks, all patients giving written informed consent will receiving injection of indocyanine greenat 8 points around the primary tumor with gastroscope 1 day before surgery. During the operation, laparoscopic gastrectomy and perigastric lymph node dissection were performed under ICG imaging equipment. After the surgical specimens were isolated, under the fluorescent illumination of the ICG imaging equipment, the lymph nodes that showed fluorescence and the lymph nodes that did not show fluorescence were collected from each LN station.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
180 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Prospective Clinical Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy With Lymph Node Dissection for Early Gastric Cancer
Anticipated Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental: Indocyanine Green Tracer

Indocyanine Green Tracer will be used in laparoscopic distal gastrectomy with lymph node dissection for gastric adenocarcinoma.

Drug: Indocyanine Green
Laparoscopic distal gastrectomy with lymph node dissection for early gastric cancer using Indocyanine Green Tracer
Other Names:
  • ICG

    		•

    Outcome Measures

    Primary Outcome Measures

    1. False negative rate [One month after surgery]

      The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes

    Secondary Outcome Measures

    1. True positive rate [One month after surgery]

      The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes

    2. False positive rate [One month after surgery]

      The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes

    3. True negative rate [One month after surgery]

      The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes

    4. Total number of retrieved lymph nodes [One month after surgery]

      Total number of retrieved lymph nodes

    5. Lymph node noncompliance rate [One month after surgery]

      Lymph node noncompliance was defined as the absence of lymph nodes that should have been excised from more than 1 lymph node station. Major lymph node noncompliance was defined as more than 2 intended lymph node stations that were not removed.

    6. Number of Metastasis Lymph Nodes [One month after surgery]

      Number of Metastasis Lymph Nodes

    7. Metastasis rate of lymph node [One month after surgery]

      Metastasis rate of lymph node

    8. Morbidity and mortality rates [One month after surgery]

      This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.

    9. 3-year overall survival rate [36 months]

      3-year overall survival rate

    10. 3-year disease free survival rate [36 months]

      3-year disease free survival rate

    11. 3-year recurrence pattern [36 months]

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

    12. Intraoperative morbidity rates [1 day]

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

    13. Time to first ambulation [30 days]

      Time to first ambulation in hours is used to assess the postoperative recovery course.

    14. Time to first flatus [30 days]

      Time to first flatus in days is used to assess the postoperative recovery course.

    15. Time to first liquid diet [30 days]

      Time to first liquid diet in days is used to assess the postoperative recovery course.

    16. Time to first soft diet [30 days]

      Time to first soft diet in days is used to assess the postoperative recovery course.

    17. Duration of postoperative hospital stay [30 days]

      Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.

    18. The variation of white blood cell count [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.

    19. The variation of hemoglobin [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.

    20. The variation of C-reactive protein [Preoperative 3 days and postoperative 1, 3, and 5 days]

      The variation of C-reactive protein

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 75 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age from 18 to 75 years

    2. Primary gastric adenocarcinoma (papillary, tubular, mucinous, signet ring cell, or poorly differentiated) confirmed pathologically by endoscopic biopsy

    3. Clinical stage tumor T1 (cT1), N0/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Eighth Edition. Preoperative staging was made by conducting mandatory computed tomography (CT) scans and an optional endoscopic ultrasound

    4. No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations

    5. Tumor located in the lower third of the stomach, expected to receive radical distal gastrectomy

    6. Performance status of 0 or 1 on Eastern Cooperative Oncology Group scale (ECOG)

    7. American Society of Anesthesiology score (ASA) class I, II, or III

    8. Written informed consent

    Exclusion Criteria:

    1. Women during pregnancy or breast-feeding

    2. Severe mental disorder

    3. History of previous upper abdominal surgery (except laparoscopic cholecystectomy)

    4. History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection

    5. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging

    6. History of other malignant disease within past five years

    7. History of previous neoadjuvant chemotherapy or radiotherapy

    8. History of unstable angina or myocardial infarction within past six months

    9. History of cerebrovascular accident within past six months

    10. History of continuous systematic administration of corticosteroids within one month

    11. Requirement of simultaneous surgery for other disease

    12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer

    13. Forced expiratory volume in 1 second (FEV1)<50% of predicted values

    14. Rejection of laparoscopic resection

    15. Preoperatively confirmed tumors invading the dentate line or duodenum

    16. History of allergy to iodine agents

    17. Tumor located in the upper third of the stomach, expected to receive radical total gastrectomy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Gastric Surgery Fuzhou Fujian China

    Sponsors and Collaborators

    • Fujian Medical University

    Investigators

    • Study Chair: Chang-Ming Huang, MD, Fujian Medical University Union Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Chang-Ming Huang, Prof., Professor, Fujian Medical University
    ClinicalTrials.gov Identifier:
    NCT04973475
    Other Study ID Numbers:
    • FUGES-023
    First Posted:
    Jul 22, 2021
    Last Update Posted:
    Jul 22, 2021
    Last Verified:
    Jul 1, 2021
    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., Professor, Fujian Medical University
    Stomach Neoplasms
    Indocyanine Green Tracer
    Laparoscopic Distal Gastrectomy
    Lymph Node Dissection
    Additional relevant MeSH terms:
    Stomach Neoplasms

    Study Results

    No Results Posted as of Jul 22, 2021