NCT04593615

Brief Summary

Patients with locally advanced gastric adenocarcinoma (CT2-4a N0/+ 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 by comparing injection ICG group and non-injection ICG group.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
1,070

participants targeted

Target at P75+ for not_applicable gastric-cancer

Timeline
28mo left

Started Nov 2020

Longer than P75 for not_applicable gastric-cancer

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Study Progress71%
Nov 2020Aug 2028

First Submitted

Initial submission to the registry

October 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 20, 2020

Completed
21 days until next milestone

Study Start

First participant enrolled

November 10, 2020

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 17, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 17, 2028

Last Updated

December 30, 2024

Status Verified

December 1, 2024

Enrollment Period

5.8 years

First QC Date

October 16, 2020

Last Update Submit

December 26, 2024

Conditions

Gastric CancerSurgery

Keywords

Indocyanine Green TracerLaparoscopic GastrectomyGastric Cancer

Outcome Measures

Primary Outcomes (1)

  • 3-year disease free survival rate

    Disease-free survival is calculated from the day of surgery to the day of recurrence or death

    3 years

Secondary Outcomes (17)

  • Total number of retrieved lymph nodes

    30 days

  • Noncompliance rate of lymph node dissection

    30 days

  • Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A

    30 days

  • Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)

    30 days

  • Relationship between fluorescent lymph nodes in Group A and negative lymph nodes in Group A (false positive rate)

    30 days

  • +12 more secondary outcomes

Study Arms (2)

Group A

EXPERIMENTAL

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

Procedure: ICG near-infrared imaging

Group B

PLACEBO COMPARATOR

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

Procedure: ICG near-infrared imaging

Interventions

ICG near-infrared imagingPROCEDURE

Indocyanine green tracer is used to guide laparoscopic D2 lymph node dissection for gastric cancer

Group AGroup B

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
  • cT2-4a, N-/+, M0 at preoperative evaluation according to the AJCC Cancer Staging Manual, 8th Edition
  • No distant metastasis, no direct invasion of pancreas, spleen or other adjacent organs in the preoperative examinations
  • Performance status of 0 or 1 on the ECOG (Eastern Cooperative Oncology Group) scale
  • ASA (American Society of Anesthesiology) class I to 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 for laparoscopic cholecystectomy)
  • History of previous gastric surgery (including ESD/EMR for gastric cancer)
  • Enlarged or bulky regional lymph node (diameter over 3cm) supported by preoperative imaging including enlarged or bulky No.10 lymph nodes
  • Other malignant disease within the past 5 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 for simultaneous surgery for other disease
  • Emergency surgery due to complication (bleeding, obstruction or perforation) caused by gastric cancer
  • FEV1 (forced expiratory volume in one second)\<50% of predicted values
  • Diffuse invasive gastric cancer
  • Tumors preoperatively confirmed to involve the squamocolumnar junction or duodenum
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Related Publications (1)

  • Zheng CH, Chen YB, Yu WB, Cai LS, Wang Q, Sun YH, Yan S, He XL, Xu ZK, Li GX, Tian YT, Li C, Wang BG, Ji JF, Xu YC, Zhong Q, Liu ZY, Chen QY, Li P, Xie JW, Liang Y, Liu ZM, Qiu HB, Wei M, Yan ZB, Lv CB, Chen QX, Li S, Zeng LX, Huo BW, Li ZY, Su XQ, Huang CM; Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group. Safety and efficacy of indocyanine green-guided laparoscopic lymphadenectomy for locally advanced gastric cancer: The CLASS-11 clinical trials. Cell Rep Med. 2025 May 20;6(5):102136. doi: 10.1016/j.xcrm.2025.102136.

    PMID: 40398388DERIVED

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesStomach Diseases

Study Officials

  • Chang-Ming Huang, Pro.

    Fujian Medical University Union Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 16, 2020

First Posted

October 20, 2020

Study Start

November 10, 2020

Primary Completion (Estimated)

August 17, 2026

Study Completion (Estimated)

August 17, 2028

Last Updated

December 30, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

The primary outcome of this study has not yet been reported. Any additional information required to reanalyze the data reported in this work paper is available from the lead contact upon request. Huang CM had full access to all of the data in the study and take responsibility for the integrity of the data and the accuracy of the data analysis. The data supporting the findings in this study are available under controlled access.

Locations

CN(1)