NCT03050879

Brief 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）.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
266

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 13, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

October 15, 2017

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2019

Completed
Last Updated

April 24, 2025

Status Verified

April 1, 2025

Enrollment Period

1.7 years

First QC Date

January 13, 2017

Last Update Submit

April 22, 2025

Conditions

Stomach NeoplasmsIndocyanine Green

Keywords

Stomach NeoplasmsIndocyanine Green TracerLaparoscopic GastrectomyLymph Node Dissection

Outcome Measures

Primary Outcomes (1)

  • Total Number of Retrieved Lymph Nodes

    Compare total number of retrieved lymph nodes in both group.

    14 days

Secondary Outcomes (29)

  • The rate of fluorescence

    14 days

  • Positive rate

    14 days

  • False positive rate

    14 days

  • Negative rate

    14 days

  • False negative rate

    14 days

  • +24 more secondary outcomes

Study Arms (2)

Indocyanine Green Tracer

EXPERIMENTAL

Indocyanine Green Tracer will be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.

Drug: Indocyanine Green Tracer

No Indocyanine Green Tracer

ACTIVE COMPARATOR

Indocyanine Green Tracer will not be used in laparoscopic gastrectomy with lymph node dissection for gastric adenocarcinoma in this group.

Drug: Indocyanine Green Tracer

Interventions

Indocyanine Green TracerDRUG

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

Also known as: ICG
Indocyanine Green TracerNo Indocyanine Green Tracer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350000, China

Location

Related Publications (4)

  • 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.

    PMID: 40859341DERIVED

  • 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.

    PMID: 37973806DERIVED

  • 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.

    PMID: 37939147DERIVED

  • 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.

    PMID: 32101269DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Changming Huang, Professor

    Fujian Medical University Union Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

January 13, 2017

First Posted

February 13, 2017

Study Start

October 15, 2017

Primary Completion

July 13, 2019

Study Completion

July 13, 2019

Last Updated

April 24, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)