Summary of findings'. 'Summary of findings: Traceable agents for sentinel lymph node assessment in vulval cancer.
Review question: how does the diagnostic test accuracy of various techniques using traceable agents for sentinel lymph node assessment in vulval cancer compare? Patients or population: women with FIGO stage IB or higher vulval cancer without palpable/suspicious groin nodes Settings: tertiary level hospitals Role: to diagnose groin lymph node metastases Index tests: blue dye, technetium, combined tests (blue dye and technetium) and mixed tests (blue dye, technetium or combined tests) Reference standard: histological examination following complete inguinofemoral lymphadenectomy Studies: prospective (30) and retrospective (4) cohort | ||||||||
Index test | Quantity of evidence | Mean detection rate* | Pooled sensitivity results per woman (95% CI) | Consequences in a cohort of 100 women undergoing SN assessment, assuming the prevalence of groin metastases to be 30% | ||||
No SNs detected** (undetected) |
Women with metastatic nodes diagnosed by index test (TP) |
Women with metastatic nodes missed by index test (FN) |
Women requiring IFL*** | Women not requiring IFL | ||||
1. Blue dye | 68 women (3 studies) |
82% | 94% (69% to 99%) | 18 | 23 (17 to 25) | 2 (0 to 8) | 41 | 59 |
2. Technetium | 149 women (8 studies) |
96% | 93% (89% to 96%) | 4 | 27 (26 to 28) | 2 (1 to 3) | 31 | 69 |
3. Combined tests (blue dye + technetium) | 390 women (12 studies) |
98% | 95% (89% to 97%) | 2 | 28 (26 to 29) | 1 (1 to 3) | 30 | 70 |
4. Mixed tests | 679 women (7 studies) |
95% | 91% (71% to 98%) | 5 | 26 (20 to 28) | 3 (1 to 9) | 32 | 68 |
Studies which employed 'mixed tests' used a combination of the index tests 1 to 3 and presented the overall results (i.e. did not present results separately for the different tests).
The detection rate is the percentage of patients in which the test located a sentinel node. In patients where no node is detected, the test has no value.
*These mean detection rates are estimates derived from the total number of participants included in the studies for each test (see Table 3).
**Undetected women require complete inguinofemoral lymphadenectomy (IFL).
***Undetected women + correctly diagnosed women (TPs).
TP = true positives; FN = false negatives