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

July 13, 2021 updated by: Chang-Ming Huang, Prof., Fujian Medical University

Prospective Clinical Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Distal Gastrectomy With Lymph Node Dissection 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

180

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 Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China
        • Department of Gastric Surgery
        • 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One month after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
36 months
Intraoperative morbidity rates
Time Frame: 1 day
The intraoperative postoperative morbidity rates are defined as the rates of event observed within operation.
1 day
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.
Preoperative 3 days and postoperative 1, 3, and 5 days
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.
Preoperative 3 days and postoperative 1, 3, and 5 days
Time to first ambulation
Time Frame: 30 days
Time to first ambulation in hours is used to assess the postoperative recovery course.
30 days
Time to first flatus
Time Frame: 30 days
Time to first flatus in days is used to assess the postoperative recovery course.
30 days
Time to first liquid diet
Time Frame: 30 days
Time to first liquid diet in days is used to assess the postoperative recovery course.
30 days
Time to first soft diet
Time Frame: 30 days
Time to first soft diet in days is used to assess the postoperative recovery course.
30 days
Duration of postoperative hospital stay
Time Frame: 30 days
Duration of postoperative hospital stay in days is used to assess the postoperative recovery course.
30 days
3-year disease free survival rate
Time Frame: 36 months
3-year disease free survival rate
36 months
3-year overall survival rate
Time Frame: 36 months
3-year overall survival rate
36 months
Number of Metastasis Lymph Nodes
Time Frame: One month after surgery
Number of Metastasis Lymph Nodes
One month after surgery
Metastasis rate of lymph node
Time Frame: One month after surgery
Metastasis rate of lymph node
One month after surgery
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
One month after surgery
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
One month after surgery
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
One month after surgery
Total number of retrieved lymph nodes
Time Frame: One month after surgery
Total number of retrieved lymph nodes
One month after surgery
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.
One month after surgery
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.
One month after surgery
The variation of C-reactive protein
Time Frame: Preoperative 3 days and postoperative 1, 3, and 5 days
The variation of C-reactive protein
Preoperative 3 days and postoperative 1, 3, and 5 days

Collaborators and Investigators

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

Sponsor

Fujian Medical University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Anticipated)

July 1, 2021

Primary Completion (Anticipated)

July 1, 2023

Study Completion (Anticipated)

July 1, 2026

Study Registration Dates

First Submitted

July 13, 2021

First Submitted That Met QC Criteria

July 13, 2021

First Posted (Actual)

July 22, 2021

Study Record Updates

Last Update Posted (Actual)

July 22, 2021

Last Update Submitted That Met QC Criteria

July 13, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FUGES-023

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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