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(accuracy: 98%).

Diagnostic test accuracy according to histological methods: only one of the three identified meta- LoE 1-
analyses91 described pooled estimates of sensitivity for the combined technique (blue dye/99mTc)

according to histological methods:

 Ultrastaging only: 95% (95% CI = 91-97) (per groin data), 95% (95% CI = 89-98) (per patient
data)

 Ultrastaging and/or immunohistochemistry (IHC): 94% (95% CI = 88-97) (per groin data), 95%
(95% CI = 90-98) (per patient data)

In the GROINSS-V170, ultrastaging detected a positive SLN in 55 (41%) of 135 patients (66 (40%) of LoE 2++
164 groins). After multiple sectioning, IHC identified micrometastases in 36 (12%) of 304 patients
with a negative sentinel node. The risk of metastases in non-SLN was higher when the SLN was
found to be positive by traditional pathologic processing than when the SLN was found to be
positive only with ultrastaging (23 of 85 groins (27%) versus 3 of 56 groins (5%), p = 0.001). In
Gynecologic oncology group (GOG) protocol 173135, 23% of all positive SLNs were missed by
routine H&E staining of SLN tissue cut and were only detected with the addition of
immunohistochemical stains.

Nine smaller studies50,54,58,65,67,77,84,112,118 have also reported micrometastases found after ultrastaging LoE 2+
and/or IHC among patients that were previously negative with standard H&E.

Visualization of the SLN by scintigraphy: in GOG protocol 173, Coleman et al.155 reported a negative LoE 2++
correlation between distance of vulvar lesion from midline and the probability of detecting bilateral
drainage in preoperative lymphoscintigraphy. Thirty percent of women with tumours invading or
crossing the midline had unilateral drainage on lymphoscintigraphy. However, authors observed that
more than one in five patients with lateralized primary tumours (> 2 cm from the midline) had
bilateral drainage on lymphoscintigraphy.

Out of 42 patients with midline tumours enrolled in the retrospective review published by Lindell et LoE 2+
al.125, only 18 had bilateral lymphatic drainage at scintigram. The lymphoscintigraphy showed

unilateral lymphatic drainage in 40 out of 58 patients, including all 16 patients with lateral lesions.
Louis-Sylvestre et al.157 found that of 13 patients with lesions less than 1 cm from the midline in

whom lymphoscintigraphy identified only unilateral drainage, 3 patients had metastatic disease in

nodes located in the contralateral, lymphoscintigraphy-negative groin. Six identified
studies102,117,118,160,171,172 assessed detection rate of the preoperative visualization of the SLN by

scintigraphy and all of them reported a detection rate greater than 90%.

De Cicco et al.97 used preoperative and intraoperative lymphoscintigraphy alone to successfully
identify at least one sentinel node in each of the 37 patients in their series. There were no false-
negative sentinel nodes. Eight patients had positive nodes, and the sentinel node was the only
positive node in 5 of these cases. If lymphoscintigraphy did not identify a sentinel node in a groin, no
metastases were found at surgery. Using a combination of preoperative lymphoscintigraphy and
intraoperative lymphoscintigraphy, de Hullu et al.98 reported that all the 23 patients with lateral
lesions or with tumours primarily labial but came within 1 cm of the midline had unilateral SLN
detected in the groin on preoperative lymphoscintigraphy and at the time of surgery.

In a very small study enrolling 10 patients, DeCesare et al.93 showed that intraoperative
lymphoscintigraphy correctly identified the nodal status as positive in all 4 cases of metastatic
disease and negative in all 16 groins negative for metastases.

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