ClinicalTrials.gg
Status unknownNCT04611997Updated Sep 18, 2023

IGG Using in Laparoscopic Gastrectomy for Locally Advanced Gastric Cancer After Neoadjuvant Chemotherapy

A Phase 3 interventional study of Indocyanine Green in Gastric Cancer and Lymph Node Metastases, sponsored by Fujian Medical University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-18.

Sponsored by Fujian Medical University · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2023), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
240
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

Patients with locally advanced gastric adenocarcinoma (cT2-4a N-/+ M0) were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic D2 lymph node dissection for gastric cancer after neoadjuvant chemotherapy by comparing injection ICG group and non-injection ICG group

02

Conditions studied

  • Gastric Cancer
  • Lymph Node Metastases
03

In context

Stomach Neoplasms

2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.

This study's planned enrollment of 240 is above the median of 66 across 2,143 interventional studies indexed under Stomach Neoplasms.

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Lead sponsor

Fujian Medical University is the lead sponsor of 148 studies on the registry; 52 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition
  4. No distant metastasis, no invasion of pancreas, spleen or other adjacent organs 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) score I to III
  7. Written informed consent

Exclusion criteria

Exclusion Criteria:

  1. Women during pregnancy or breast-feeding
  2. Severe mental disorder
  3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy)
  4. History of previous gastric surgery (including ESD/EMR for gastric cancer)
  5. Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging.
  6. Other malignant disease within the past 5 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 for simultaneous surgery for other disease
  12. Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  13. FEV1 (forced expiratory volume in one second)\<50% of predicted values
  14. Diffuse invasive gastric cancer
  15. Preoperatively, tumors involving the squamocolumnar junction or duodenum were confirmed
  16. A history of iodine allergy
  17. Refuse laparoscopic surgery
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
240 participants (estimated)

Study arms

  • Experimental
    Group A

    Laparoscopic gastrectomy group with the use of near-infrared imaging (ICG group)

    Drug: Indocyanine Green

  • Placebo comparator
    Group B

    Laparoscopic gastrectomy group without the use of near-infrared imaging (Non-ICG group)

    Drug: Indocyanine Green

Interventions

  • Indocyanine Green Tracer Using in Laparoscopic Gastrectomy with Lymph Node Dissection for Locally Advanced Gastric Cancer After Neoadjuvant

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What researchers measure

Primary outcomes

  1. 3-year disease free survival rate

    Disease-free survival is calculated from the day of surgery to the day of recurrence (When the specific date of recurrence of the tumor is unknown, the ending point is the date of death due to tumor causes). In the event that neither death nor recurrence of the tumor are observed, the end point is the final date that a patient is confirmed as relapse-free.

    Time frame: 3 years

Secondary outcomes

  1. Total number of retrieved lymph nodes

    Total number of retrieved lymph nodes

    Time frame: 30 days

07

Study locations

1 site
  • Chang-ming Huang
    Fuzhou, Fujian 350001, China
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 18, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04611997
Responsible party
Chang-Ming Huang, Prof. (Professor, Fujian Medical University) — Principal investigator
First posted
Nov 2, 2020
Start date
Nov 16, 2020
Primary completion
Oct 1, 2026 (estimated)
Completion
Oct 1, 2026 (estimated)
Last update
Sep 18, 2023

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Indocyanine Green

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