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Stomach NeoplasmsPhase 2ICGTinLGNCT03050879

Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection

A Phase 2 study testing Indocyanine Green Tracer in people with Stomach Neoplasms and Indocyanine Green, run by Fujian Medical University at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma（cT1-4a, N-/+, M0）. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Stomach Neoplasms, Indocyanine Green
What is being tested?
Indocyanine Green Tracer
Could I receive a placebo?
No, everyone receives an active treatment
How many people
266 participants
Where
1 siteChina
Study dates
15 Oct 2017to 13 Jul 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 1-4a (cT1-4a), N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition
  • No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby in the preoperative examinations
  • 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

Who cannot join

  • 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
Show all 14Show fewer
  • 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
  • FEV1<50% of predicted values
  • Diffuse; widespread; plastica

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350000

Other trials in China

About this study

Official title: Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Gastric Cancer

The purpose of this study is to explore the clinical outcomes of Indocyanine Green Tracer using in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma（cT1-4a, N-/+, M0）.

Read the detailed description

Indocyanine Green Tracer is often applied in surgery for early gastric adenocarcinoma. Its application in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma 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 gastric adenocarcinoma.

On the basis of more than 3000 cases of laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma, 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 gastric adenocarcinoma, to guid the scope of laparoscopic lymph node dissection for gastric adenocarcinoma.

Being tested
Indocyanine Green Tracer
Keywords
Stomach Neoplasms, Indocyanine Green Tracer, Laparoscopic Gastrectomy, Lymph Node Dissection
Medical subject headings
Stomach Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indocyanine Green TracerDrug

    Also called ICG

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

Study groups in NCT03050879
Study groupRoleWhat they receive
Indocyanine Green TracerExperimentalIndocyanine Green Tracer will be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
Receives: Drug: Indocyanine Green Tracer
No Indocyanine Green TracerActive comparatorIndocyanine Green Tracer will not be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.
Receives: Drug: Indocyanine Green Tracer

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total Number of Retrieved Lymph Nodes

    Compare total number of retrieved lymph nodes in both group.

    Measured: 14 days

Secondary outcomes (29)

  1. The rate of fluorescence

    The number of fluorescent lymph node in experimental group is divided by the total number of lymph nodes in active experimental group

    Measured: 14 days

  2. Positive rate

    The number of positive lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group

    Measured: 14 days

  3. False positive rate

    The number of negative lymph nodes in fluorescent lymph nodes is divided by the number of total fluorescent lymph nodes in experimental group

    Measured: 14 days

  4. Negative rate

    The number of negative lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group

    Measured: 14 days

  5. False negative rate

    The number of positive lymph nodes in not fluorescent lymph nodes is divided by the number of total not fluorescent lymph nodes in experimental group

    Measured: 14 days

  6. Number of Metastasis Lymph Nodes

    Compare number of positive lymph nodes in both group.

    Measured: 14 days

  7. Metastasis rate of lymph node

    Compare metastasis rate of lymph node in both group

    Measured: 14 days

  8. Morbidity and mortality rates

    This is for the early postoperative complication and mortality, which defined as the event observed within 30 days after surgery.

    Measured: 30 days

  9. 3-year disease free survival rate

    disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause

    Measured: 36 months

  10. 3-year recurrence pattern

    Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.

    Measured: 36 months

  11. Postoperative recovery course

    Time to first ambulation, flatus, liquid diet and soft diet, duration of postoperative hospital stay and postoperative pain are used to assess the postoperative recovery course.Visual analog pain score method is used to evaluate the difference of postoperative pain degree.

    Measured: 10 days

  12. Operation time

    Measured: 1 day

  13. The variation of weight

    The variation of weight on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.

    Measured: 3, 6, 9 and 12 months

  14. Intraoperative blood loss

    Measured: 1 day

  15. Conversive rate

    Measured: 1 day

  16. Intraoperative morbidity rates

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

    Measured: 1 day

  17. Incision length

    Measured: 1 day

  18. The variation of cholesterol

    The variation of cholesterol in millimole/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.

    Measured: 3, 6, 9 and 12 months

  19. The variation of album

    The variation of album in gram/liter on postoperative 3, 6, 9 and 12 months are used to access the postoperative nutritional status and quality of life.

    Measured: 3, 6, 9 and 12 months

  20. The results of endoscopy

    The incidence of reflux esophagitis under the endoscopy on postoperative 3 and 12 months are used to access the postoperative quality of life.

    Measured: 3, 6, 9 and 12 months

  21. The variation of body temperature

    The daily highest body temperature in degree centigrade before discharge are recorded to access the inflammatory and immune response.

    Measured: 8 days

  22. The variation of white blood cell count

    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.

    Measured: Preoperative 3 days and postoperative 1, 3, and 5 days

  23. The variation of hemoglobin

    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.

    Measured: Preoperative 3 days and postoperative 1, 3, and 5 days

  24. The variation of C-reactive protein

    The values of C-reactive protein IN milligram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

    Measured: Preoperative 3 days and postoperative 1, 3, and 5 days

  25. The variation of prealbumin

    The values of prealbumin in gram/liter from peripheral blood before operation and on postoperative day 1, 3, 5 are recorded to access the inflammatory and immune response.

    Measured: Preoperative 3 days and postoperative 1, 3, and 5 days

  26. 3-year overall survival rate

    Overall survival was defined as the time from surgery to death from any cause

    Measured: 36 months

  27. 5-year overall survival rate

    Overall survival was defined as the time from surgery to death from any cause

    Measured: 60 months

  28. 5-year disease free survival rate

    disease-free survival was defined as the time from surgery to the time of recurrence or death from any cause

    Measured: 60 months

  29. 5-year recurrence pattern

    Recurrence patterns are classified into five categories at the time of first diagnosis: locoregional, hematogenous, peritoneal, distant lymph node, and mixed type.

    Measured: 60 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Feb 2017
  2. Study start15 Oct 2017
  3. Primary completion13 Jul 2019
  4. Study completion13 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
266 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03050879
Sponsor's protocol ID
FUGES-012
Acronym
ICGTinLG
Status last verified
Apr 2025
First submitted
13 Jan 2017
Last updated
24 Apr 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Zhong Q, Wu D, Liu ZY, Shang-Guan ZX, Huang ZN, Zhang ZQ, Qiu TY, Chen JY, Jiang YM, Lin GT, Tang YH, Li P, Xie JW, Lin JX, Zheng CH, Chen QY, Huang CM. Long-term oncological outcomes of indocyanine green fluorescence imaging-guided laparoscopic lymphadenectomy for gastric cancer: 5-year outcomes from the FUGES-012 randomized clinical trial. BMC Med. 2025 Aug 26;23(1):497. doi: 10.1186/s12916-025-04334-1.

    PubMed 40859341

  • Chen QY, Zhong Q, Liu ZY, Li P, Lin GT, Zheng QL, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Zeng GR, Jiang MC, Wang HG, Huang XB, Xu KX, Li YF, Zheng CH, Xie JW, Huang CM. Indocyanine green fluorescence imaging-guided versus conventional laparoscopic lymphadenectomy for gastric cancer: long-term outcomes of a phase 3 randomised clinical trial. Nat Commun. 2023 Nov 16;14(1):7413. doi: 10.1038/s41467-023-42712-6.

    PubMed 37973806

  • Huang ZN, He QC, Qiu WW, Wu J, Zheng CY, Lin GS, Li P, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Zheng CH, Chen QY, Huang CM, Xie JW. OSATS scoring confirms ICG enhancement of performance in laparoscopic radical gastrectomy: a post-hoc analysis of a randomized controlled trial. Int J Surg. 2024 Jan 1;110(1):342-352. doi: 10.1097/JS9.0000000000000830.

    PubMed 37939147

  • Chen QY, Xie JW, Zhong Q, Wang JB, Lin JX, Lu J, Cao LL, Lin M, Tu RH, Huang ZN, Lin JL, Zheng HL, Li P, Zheng CH, Huang CM. Safety and Efficacy of Indocyanine Green Tracer-Guided Lymph Node Dissection During Laparoscopic Radical Gastrectomy in Patients With Gastric Cancer: A Randomized Clinical Trial. JAMA Surg. 2020 Apr 1;155(4):300-311. doi: 10.1001/jamasurg.2019.6033.

    PubMed 32101269

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Indocyanine Green Tracer in people with Stomach Neoplasms and Indocyanine Green, run by Fujian Medical University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Total Number of Retrieved Lymph Nodes (time frame: 14 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03050879, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2025.

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