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

November 9, 2022 updated by: Chang-Ming Huang, Prof., Fujian Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

68

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350000
        • Recruiting
        • Fujian Medical University Union Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Number of Retrieved Lymph Nodes
Time Frame: 30 days
Total Number of Retrieved Lymph Nodes
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lymph node noncompliance rate
Time Frame: 30 days
Lymph node noncompliance rate
30 days
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
30 days
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)
30 days
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)
30 days
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)
30 days
Number of Metastasis Lymph Nodes
Time Frame: 30 days
Number of Metastasis Lymph Nodes
30 days
Metastasis rate of lymph node
Time Frame: 30 days
Metastasis rate of lymph node
30 days
Postoperative morbidity rate
Time Frame: 30 days
Postoperative morbidity rate
30 days
Postoperative mortality rate
Time Frame: 30 days
Postoperative mortality rate
30 days
3-year overall survival rate
Time Frame: 3 years
3-year overall survival rate
3 years
3-year disease-free survival rate
Time Frame: 3 years
3-year disease-free survival rate
3 years
3-year recurrence pattern
Time Frame: 3 years
3-year recurrence pattern
3 years
Postoperative recovery course
Time Frame: 30 days
Time to first ambulation, flatus, liquid diet and soft diet, and postoperative hospital stay
30 days
Intraoperative situation
Time Frame: 30 days
Operation time, intraoperative blood loss, and intraoperative morbidity rate
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 3, 2022

Primary Completion (Anticipated)

April 1, 2025

Study Completion (Anticipated)

April 1, 2028

Study Registration Dates

First Submitted

June 3, 2022

First Submitted That Met QC Criteria

November 9, 2022

First Posted (Actual)

November 16, 2022

Study Record Updates

Last Update Posted (Actual)

November 16, 2022

Last Update Submitted That Met QC Criteria

November 9, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUGES-027

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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