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NCT Number: NCT05618821

Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer

Patients with resectable remnant gastric cancer were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic lymph node dissection for remnant gastric cancer by comparing injection ICG group and non-injection ICG group.

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Key information

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

Location status: Recruiting

Location contact

Hualong Zheng

CONTACT

[email protected]

+8618359190587

About this study

Indocyanine Green Tracer is often applied in surgery for gastric cancer. Its application in laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer 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 remnant gastric cancer. On the basis of more than 300 cases of laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer, 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 remnant gastric cancer, to guid the scope of laparoscopic lymph node dissection for remnant gastric cancer.

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
  • Remnant gastric cancer (cT1-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition)

(4) No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations (5) Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale (6) ASA (American Society of Anesthesiology) class I to III (7) Written informed consent

Exclusion criteria

  • Women during pregnancy or breast-feeding
  • Severe mental disorder
  • History of previous upper abdominal surgery (except for laparoscopic cholecystectomy and gastrectomy)
  • History of previous gastric surgery (including ESD/EMR for gastric cancer)
  • Rejection of laparoscopic resection
  • History of allergy to iodine agents
  • 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 the past six months
  • History of unstable angina or myocardial infarction within past six months
  • History of continuous systematic administration of corticosteroids within one month
  • Requirement of simultaneous surgery for another disease
  • Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1<50% of the predicted values
  • Linitis plastica, Widespread

Treatment and study plan

Indocyanine Green Tracer

Drug

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

Primary outcomes

  1. Total Number of Retrieved Lymph Nodes

    Time frame: 30 days

    Total Number of Retrieved Lymph Nodes

Secondary outcomes

  1. Lymph node noncompliance rate

    Time frame: 30 days

    Lymph node noncompliance rate

  2. Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group

    Time frame: 30 days

    Relationship between fluorescent lymph nodes in the ICG group and total number of lymph nodes in the ICG group

  3. Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate)

    Time frame: 30 days

    Relationship between fluorescent lymph nodes in the ICG group and positive lymph nodes in the ICG group (positive rate)

  4. Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate)

    Time frame: 30 days

    Relationship between fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (false positive rate)

  5. Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate)

    Time frame: 30 days

    Relationship between non-fluorescent lymph nodes in the ICG group and negative lymph nodes in the ICG group (negative rate)

  6. Number of Metastasis Lymph Nodes

    Time frame: 30 days

    Number of Metastasis Lymph Nodes

  7. Metastasis rate of lymph node

    Time frame: 30 days

    Metastasis rate of lymph node

  8. Postoperative morbidity rate

    Time frame: 30 days

    Postoperative morbidity rate

  9. Postoperative mortality rate

    Time frame: 30 days

    Postoperative mortality rate

  10. 3-year overall survival rate

    Time frame: 3 years

    3-year overall survival rate

  11. 3-year disease-free survival rate

    Time frame: 3 years

    3-year disease-free survival rate

  12. 3-year recurrence pattern

    Time frame: 3 years

    3-year recurrence pattern

  13. Postoperative recovery course

    Time frame: 30 days

    Time to first ambulation, flatus, liquid diet and soft diet, and postoperative hospital stay

  14. Intraoperative situation

    Time frame: 30 days

    Operation time, intraoperative blood loss, and intraoperative morbidity rate

Study contacts

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

Hualong Zheng

CONTACT

[email protected]

+8618359190587

Sponsors and collaborators

Lead sponsor

Fujian Medical University

Other

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2028
First posted
Nov 16, 2022
Registry last updated
Nov 16, 2022

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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