NCT05618821 Clinical Outcomes of Indocyanine Green Tracer Using in Laparoscopic Gastrectomy With Lymph Node Dissection for Remnant Gastric Cancer
| NCT ID | NCT05618821 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Fujian Medical University |
| Condition | Gastric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 68 participants |
| Start Date | 2022-06-03 |
| Primary Completion | 2025-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 68 participants in total. It began in 2022-06-03 with a primary completion date of 2025-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Patients with resectable remnant gastric cancer were selected as study subjects to investigate the safety, efficacy, and feasibility of ICG near-infrared imaging tracing in guiding laparoscopic lymph node dissection for remnant gastric cancer by comparing injection ICG group and non-injection ICG group.
Eligibility Criteria
Inclusion Criteria: 1. Age from 18 to 75 years 2. Remnant gastric cancer (cT1-4a, N-/+, M0 at preoperative evaluation according to the American Joint Committee on Cancer (AJCC) Cancer Staging Manual Seventh Edition) (4) No distant metastasis, no direct invasion of pancreas, spleen or other organs nearby 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) class I to III (7) Written informed consent Exclusion Criteria: 1. Women during pregnancy or breast-feeding 2. Severe mental disorder 3. History of previous upper abdominal surgery (except for laparoscopic cholecystectomy and gastrectomy) 4. History of previous gastric surgery (including ESD/EMR for gastric cancer) 5. Rejection of laparoscopic resection 6. History of allergy to iodine agents 7. Enlarged or bulky regional lymph node diameter over 3cm by preoperative imaging 8. History of other malignant disease within past five years 9. History of previous neoadjuvant chemotherapy or radiotherapy 10. History of unstable angina or myocardial infarction within the past six months 11. History of unstable angina or myocardial infarction within past six months 12. History of continuous systematic administration of corticosteroids within one month 13. Requirement of simultaneous surgery for another disease 14. Emergency surgery due to complications (bleeding, obstruction or perforation) caused by gastric cancer 15. FEV1\<50% of the predicted values 16. Linitis plastica, Widespread
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05618821 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Gastric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05618821 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05618821 currently recruiting?
Yes, NCT05618821 is actively recruiting participants. Contact the research team at 291167038@qq.com for enrollment information.
Where is the NCT05618821 trial being conducted?
This trial is being conducted at Fuzhou, China.
Who is sponsoring the NCT05618821 clinical trial?
NCT05618821 is sponsored by Fujian Medical University. The trial plans to enroll 68 participants.
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