Clinical trial · Interventional
Sentinel Lymph Node (SLN) in Colorectal Carcinoma (CRC) With a Near-infrared (NIR)-Dye
In Vivo Study to Determine the Efficacy of Sentinel Node Mapping in Patients With Colon Carcinoma Using Near-infrared Laparoscopy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The sentinel lymph node (SLN) procedure is a standard staging technique in several types of cancer. One of the major problems of SLN mapping in colorectal cancer is the lack of an optimal dye and technique for identification of the nodes. In this study the investigators used the Near-Infrared (NIR) dye Indocyanin Green (ICG) to identify nodes with a newly developed NIR laparoscope. The investigators compared two different injection techniques; subserosal and submucosal injection. Patients planned for a laparoscopic resection of a colorectal carcinoma without distant metastases were included. Dye was injected in the subserosa or submucosa of the bowel. Ten minutes after injection the investigators searched for fluorescent nodes with the NIR laparoscope. Fluorescent nodes were harvested and analyzed by the pathologist using H\&E and additional immunohistochemistry.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Metastasis | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Near-Infrared (NIR) dye Indocyanin Green (ICG) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- SLN identification with NIR-dye-subserosa injection
- description
- Near-Infrared (NIR) dye Indocyanin Green (ICG) to identify nodes with a newly developed NIR laparoscope. The investigators compared two different injection techniques; subserosal and submucosal injection.
- interventionNames
- Procedure: Near-Infrared (NIR) dye Indocyanin Green (ICG)
- type
- ACTIVE_COMPARATOR
- label
- SLN identification with NIR-dye-submucosal injection
- description
- Near-Infrared (NIR) dye Indocyanin Green (ICG) to identify nodes with a newly developed NIR laparoscope. The investigators compared two different injection techniques; subserosal and submucosal injection.
- interventionNames
- Procedure: Near-Infrared (NIR) dye Indocyanin Green (ICG)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Oral and written Informed Consent (IC) * Age 18 years and older * Patients histological or radiological suspicion of colon cancer * Surgical resection of the tumor * Regular Pre-operative work-up Exclusion Criteria: * Gross lymph node involvement * Distant metastases * Advanced disease with invasion of adjacent structures * Prior colorectal surgery * Metastatic or T4 disease discovered during intraoperative staging * Contraindications to laparoscopy * Rectal cancer * Allergy to iodine * Patients at higher risk for anaphylactic reactions
References
Publications (0)
Data not yet available