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

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ClinicalTrials.gov Identifier: NCT05618821
Recruitment Status : Recruiting
First Posted : November 16, 2022
Last Update Posted : November 16, 2022
Sponsor:
Information provided by (Responsible Party):
Chang-Ming Huang, Prof., Fujian Medical University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Gastric Cancer Drug: Indocyanine Green Tracer Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer
Actual Study Start Date : June 3, 2022
Estimated Primary Completion Date : April 1, 2025
Estimated Study Completion Date : April 1, 2028

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: ICG
Laparoscopic gastrectomy Group with the use of near-infrared imaging (ICG group)
 Drug: Indocyanine Green Tracer
Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer
Active Comparator: Non-ICG
Laparoscopic gastrectomy Group without the use of near-infrared imaging (Non-ICG group)
 Drug: Indocyanine Green Tracer
Laparoscopic gastrectomy with lymph node dissection for remnant gastric cancer using Indocyanine Green Tracer


Outcome Measures
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Primary Outcome Measures :
  1. Total Number of Retrieved Lymph Nodes [ Time Frame: 30 days ]
    Total Number of Retrieved Lymph Nodes


Secondary Outcome Measures :
  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


Eligibility Criteria
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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:

  1. Age from 18 to 75 years
  2. 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:

  1. Women during pregnancy or breast-feeding
  2. Severe mental disorder
  3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy and gastrectomy)
  4. History of previous gastric surgery (including ESD/EMR for gastric cancer)
  5. Rejection of laparoscopic resection
  6. History of allergy to iodine agents
  7. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging
  8. History of other malignant disease within past five years
  9. History of previous neoadjuvant chemotherapy or radiotherapy
  10. History of unstable angina or myocardial infarction within the past six months
  11. History of unstable angina or myocardial infarction within past six months
  12. History of continuous systematic administration of corticosteroids within one month
  13. Requirement of simultaneous surgery for another disease
  14. Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer
  15. FEV1<50% of the predicted values
  16. Linitis plastica, Widespread
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): NCT05618821


Contacts
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Contact: Hualong Zheng +8618359190587 291167038@qq.com

Locations
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China, Fujian
Fujian Medical University Union Hospital Recruiting
Fuzhou, Fujian, China, 350000
Contact: Hualong Zheng    +8618359190587    291167038@qq.com   
Sponsors and Collaborators
Fujian Medical University
More Information
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Responsible Party: Chang-Ming Huang, Prof., Professor, Fujian Medical University
ClinicalTrials.gov Identifier: NCT05618821    
Other Study ID Numbers: FUGES-027
First Posted: November 16, 2022    Key Record Dates
Last Update Posted: November 16, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Indocyanine Green Tracer
Laparoscopic Gastrectomy
Remnant Gastric Cancer
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
 Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases