3D-4K-ICG Laparoscopic Gastrectomy for Gastric Cancer
3D-4K-ICG
Prospective Randomized Controlled Trials on Clinical Outcomes of Indocyanine Green Tracer Using in 3D Plus Ultra High Resolution Laparoscopic Gastrectomy With Lymph Node Dissection for Locally Advanced Gastric Cancer
1 other identifier
interventional
702
1 country
1
Brief 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 3D plus ultra high resolution laparoscopic gastrectomy with lymph node dissection for gastric cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 gastric-cancer
Started Jan 2023
Typical duration for phase_3 gastric-cancer
1 active site
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 Start
First participant enrolled
January 3, 2023
CompletedFirst Submitted
Initial submission to the registry
November 30, 2023
CompletedFirst Posted
Study publicly available on registry
December 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2029
ExpectedJune 24, 2024
June 1, 2024
3 years
November 30, 2023
June 20, 2024
Conditions
Keywords
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 (23)
Operation time
1 day
Total number of retrieved lymph nodes
1 day
Noncompliance rate of lymph node dissection
1 day
Relationship between fluorescent lymph nodes in group A and total number of lymph nodes in group A
1 day
Relationship between fluorescent lymph nodes in Group A and positive lymph nodes in Group A (positive rate)
1 day
- +18 more secondary outcomes
Study Arms (3)
3D-4K-ICG
EXPERIMENTALIndocyanine Green Tracer Using in 3D plus Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection
4K-ICG
EXPERIMENTALIndocyanine Green Tracer Using in Ultra High Resolution Laparoscopic Gastrectomy with Lymph Node Dissection
3D
PLACEBO COMPARATOR3D Laparoscopic Gastrectomy with Lymph Node Dissection
Interventions
Indocyanine green tracer is used with 3D plus ultra high resolution laparoscopic gastrectomy with lymph node Dissection for gastric cancer
Eligibility Criteria
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
- 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
- History of an iodine allergy
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fujian Medical University Union Hospital
Fuzhou, Fujian, 350001, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Chang-ming Huang
Fujian Medical University Union Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
November 30, 2023
First Posted
December 7, 2023
Study Start
January 3, 2023
Primary Completion
January 1, 2026
Study Completion (Estimated)
January 1, 2029
Last Updated
June 24, 2024
Record last verified: 2024-06
Data Sharing
- IPD Sharing
- Will not share