Clinical trial · Interventional
A Study to Evaluate Indocyanine Green Lymphangiography to Improve Lymphadenectomy in Gastric Cancer Patients
Indocyanine Green Lymphangiography as a Tool for Improving Lymphadenectomy in Gastric Cancer
NCT04591028CI-TRIAL-00068077withdrawnPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Lack of funding.
Summary
Brief summary (as posted)
This study will be looking at the safety and added benefit of using the Indocyanine green dye (ICG) during surgery.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine green | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Intervention
- description
- Injection of Indocyamine Green.
- interventionNames
- Drug: Indocyanine green
Primary outcomes (3)
- measure
- Positive ICG fluorescence lymph nodes
- timeFrame
- Approximately 30-90 days after surgery
- description
- Total number of lymph nodes removed after surgery that are positive for ICG fluorescence
- measure
- Disease positive lymph nodes
- timeFrame
- Approximately 30-90 days after surgery
- description
- Number of ICG positive lymph nodes that are also positive for disease
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * Patients ≥ 18 and ≤ 75 years of age. * Primary gastric adenocarcinoma of any histological subtype confirmed pathologically by endoscopic biopsy. * Clinical stage tumor T1-4a (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 adjacent organs such as pancreas and spleen in preoperative exams. * American Society of Anesthesiology score (ASA) class I, II, or III. * Written informed consent. Exclusion Criteria: * Patients ≤ 18 and ≥ 75 years of age. * History of previous upper abdominal surgery (except laparoscopic cholecystectomy). * History of previous gastrectomy, endoscopic mucosal resection or endoscopic submucosal dissection. * History of allergy to iodine agents. * History of other malignant disease within past five years. * Emergency surgery due to complication caused by gastric cancer, such as bleeding obstruction or perforation. * Patients intraoperatively/postoperatively confirmed as T4b. * Patients intraoperatively confirmed as unable to complete D2 lymph node dissection or R0 dissection.
References
Publications (0)
Data not yet available
No reference posted for this study.