| Autor: |
Frumovitz, Michael, Plante, Marie, Lee, Paula S., Sandadi, Samith, Lilja, James F., Escobar, Pedro F., Gien, Lilian T., Urbauer, Diana L., Abu-Rustum, Nadeem R. |
| Jazyk: |
angličtina |
| Rok vydání: |
2018 |
| Předmět: |
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| Popis: |
BACKGROUND: Accurate identification of sentinel lymph nodes (SLNs) in patients with cancer improves detection of metastatic disease and decreases surgical morbidity. We sought to determine whether indocyanine green (ICG) fluorescent dye is superior to isosulfan blue (IB) dye in detecting SLNs in women with cervical and uterine cancers. METHODS: Patients with clinical stage I endometrial or cervical cancer undergoing curative surgery were randomly assigned 1:1 to lymphatic mapping with IB (visualized by white light) followed by ICG (visualized by near infrared imaging) or ICG followed by IB. Permuted block randomization with stratification by study site was performed using a computerized random number generator. All subjects were blinded to their randomization assignment until after the procedure. Laparoscopic surgery with the PINPOINT near infrared fluorescence imaging system (Stryker, Kalamazoo, MI) was used in all cases. The primary outcome was effectiveness of intraoperative ICG with near infrared fluorescence imaging and blue dye in the identification of lymph nodes, defined as the number of lymph nodes identified by ICG and blue dye, respectively (confirmed as lymphoid tissue by histology), divided by the number of lymph nodes identified intraoperatively and excised. Analyses were performed in both per protocol and modified intent to treat populations. The trial was registered with ClinicalTrials.gov, number NCT02209532 and is completed and closed. FINDINGS: In the per protocol population (n=163), a total of 517 sentinel nodes were identified. Of these, 478 (93%) were confirmed to be lymph nodes on pathologic processing: 92% (219/238) of nodes that were both blue and green, 100% (7/7) of nodes that were blue only, and 95% (252/265) of nodes that were green only (p=0·33). In the modified intent to treat population (n=176), a total of 545 nodes were identified. Of these, 513 (94%) were confirmed to be lymph nodes on pathologic processing: 92% (229/248) of nodes that were both blue and green, 100% (9/9) of nodes that were blue only, and 95% (266/279) of nodes that were green only (p=0.30). INTERPRETATION: ICG identifies more sentinel nodes than IB in women with cervical and uterine cancers with no difference in the pathologic confirmation of nodal tissue between the two mapping substances. |
| Databáze: |
OpenAIRE |
| Externí odkaz: |
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