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NCT Number: NCT04973475

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Department of Gastric Surgery

Fuzhou, Fujian, China

Location contact

Chang-Ming Huang, Huang

CONTACT

[email protected]

Huang

About this study

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.

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 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
  • No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
  • Tumor located in the lower third of the stomach, expected to receive radical distal gastrectomy
  • 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
  • Forced expiratory volume in 1 second (FEV1)<50% of predicted values
  • Rejection of laparoscopic resection
  • Preoperatively confirmed tumors invading the dentate line or duodenum
  • History of allergy to iodine agents
  • Tumor located in the upper third of the stomach, expected to receive radical total gastrectomy

Treatment and study plan

Indocyanine green

Drug

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

Other names: ICG

Primary outcomes

  1. False negative rate

    Time frame: 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 outcomes

  1. True positive rate

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: One month after surgery

    Total number of retrieved lymph nodes

  5. Lymph node noncompliance rate

    Time frame: 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

    Time frame: One month after surgery

    Number of Metastasis Lymph Nodes

  7. Metastasis rate of lymph node

    Time frame: One month after surgery

    Metastasis rate of lymph node

  8. Morbidity and mortality rates

    Time frame: 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

    Time frame: 36 months

    3-year overall survival rate

  10. 3-year disease free survival rate

    Time frame: 36 months

    3-year disease free survival rate

  11. 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.

  12. Intraoperative morbidity rates

    Time frame: 1 day

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

  13. Time to first ambulation

    Time frame: 30 days

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

  14. Time to first flatus

    Time frame: 30 days

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

  15. Time to first liquid diet

    Time frame: 30 days

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

  16. Time to first soft diet

    Time frame: 30 days

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

  17. Duration of postoperative hospital stay

    Time frame: 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

    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.

  19. 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.

  20. The variation of C-reactive protein

    Time frame: Preoperative 3 days and postoperative 1, 3, and 5 days

    The variation of C-reactive protein

Study contacts

Contact information is provided by the study sponsor or research team.

Chang-Ming Huang, MD

CONTACT

[email protected]

+86-13805069676

Zu-Kai Wang, MD

CONTACT

[email protected]

+86-15659036263

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2026
First posted
Jul 22, 2021
Registry last updated
Jul 22, 2021

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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