Sliutz 2002.
| Study characteristics | |||
| Patient sampling | Prospective study; consecutive enrolment | ||
| Patient characteristics and setting | 26 women with T1/2 vulval cancer (24 with SCC, 2 other); groins not described (?46). 6 lateralised lesions, 20 midline lesions Women with clinically suspicious nodes, prior surgery/chemotherapy or radiotherapy were excluded Median age: 62.5 years (40 to 86) Setting: university hospital in Germany; recruited from May 1998 to November 2000 |
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| Index tests | Tc‐99m with (8 women) or without blue dye (18 women) Histological methods: standard sections and H&E stains were used. If SNs were negative, ultrastaging with additional IHC stains was performed |
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| Target condition and reference standard(s) | TC: groin lymph node involvement RS: complete IFL |
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| Flow and timing | 2 to 3 hours pre‐operatively, Tc‐99m (14 MBq in 0.4 ml saline) was injected intradermally at 4 sites perilesionally. Dynamic (immediately) and static images (2 hours later) were done and SNs were marked on the skin. The first 8 women also received blue dye (1 ml), injected perilesionally Radioactivity was detected intra‐operatively by gamma probe. Only 3/8 women had potential blue nodes identified by afferent blue channels SND was followed by complete IFL in the same operation |
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| Comparative | |||
| Notes | Midline not defined. 'Per groin' data were not reported. Authors e‐mailed on 2 July 2013 (unsuccessful) IHC/ultrastaging identified 1 additional micrometastasis |
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| Methodological quality | |||
| Item | Authors' judgement | Risk of bias | Applicability concerns |
| DOMAIN 1: Patient Selection | |||
| Was a consecutive or random sample of patients enrolled? | Yes | ||
| Was a case‐control design avoided? | Yes | ||
| Did the study avoid inappropriate exclusions? | Yes | ||
| Low | Low | ||
| DOMAIN 2: Index Test Test group | |||
| Had the test operator performed 10 or more procedures? | Unclear | ||
| Unclear | Low | ||
| DOMAIN 3: Reference Standard | |||
| Is the reference standards likely to correctly classify the target condition? | Yes | ||
| Were the reference standard results interpreted without knowledge of the results of the index tests? | Unclear | ||
| Unclear | Low | ||
| DOMAIN 4: Flow and Timing | |||
| Was there an appropriate interval between index test and reference standard? | Yes | ||
| Did all patients receive the same reference standard? | Yes | ||
| Were all patients included in the analysis? | Yes | ||
| Were other imaging tests performed prior to the index test to rule out groin lymph node metastases? | Unclear | ||
| Unclear | |||