Near-infrared fluorescence imaging compared to standard sentinel lymph node detection with blue dye in patients with vulvar cancer - a randomized controlled trial.

OBJECTIVE: The aim of this study was to assess the superiority of ICG-99mTc-nanocolloid for the intraoperative visual detection of sentinel lymph nodes (SLNs) in vulvar squamous cell carcinoma (VSCC) patients compared to standard SLN detection using 99mTc-nanocolloid with blue dye. METHODS: In this multicenter, randomized controlled trial, VSCC patients underwent either the standard SLN procedure or with the hybrid tracer ICG-99mTc-nanocolloid. The primary endpoint was the percentage of fluorescent SLNs compared to blue SLNs. Secondary endpoints were successful SLN procedures, surgical outcomes and postoperative complications. RESULTS: Forty-eight patients were randomized to the standard (n = 24) or fluorescence imaging group (n = 24) using ICG-99mTc-nanocolloid. The percentage of blue SLNs was 65.3% compared to 92.5% fluorescent SLNs (p < 0.001). A successful SLN procedure was obtained in 92.1% of the groins in the standard group and 97.2% of the groins in the fluorescence imaging group (p = 0.33). Groups did not differ in surgical outcome, although more short-term postoperative complications were documented in the standard group (p = 0.041). CONCLUSIONS: Intraoperative visual detection of SLNs in patients with VSCC using ICG-99mTc-nanocolloid was superior compared to 99mTc-nanocolloid and blue dye. The rate of successful SLN procedures between both groups was not significantly different. Fluorescence imaging has potential to be used routinely in the SLN procedure in VSCC patients to facilitate the search by direct visualization. CLINICAL TRIAL REGISTRATION: Netherlands Trial Register (Trial ID NL7443).

Evaluation of the treatment tradeoff method in rectal cancer patients: is surgery preference related to outcome utilities?

BACKGROUND: The treatment tradeoff method (TTM) has been developed specifically for decision making at the level of the individual patient. The task is tailored to the clinical decision problem at hand and may therefore be more relevant to patients than methods of outcome valuation. Despite its wide use in oncology research, few methodological studies regarding validity have been conducted. OBJECTIVE AND METHODS: The present study evaluates the validity of the TTM in rectal cancer patients who had undergone either 1 of 2 surgery types: 1 requiring a permanent stoma (stoma group) and 1 involving a postoperative risk of fecal incontinence (no-stoma group). The authors relate the surgery preference scores to the utilities of the 2 main surgery outcome states as well as to their utility difference. RESULTS: Surgery preference was more strongly associated with the utility difference (r > 0.54 in the total patient group) than with the utilities of the surgery outcome states per se (r < 0.44 in the total patient group). In the stoma group, surgery preference was especially related to the utility of incontinence and in the no-stoma group especially to the utility of a permanent stoma. CONCLUSIONS: Patients indeed use their valuations of treatment outcomes states, especially those they are less familiar with, in determining their preference for one treatment over another. In clinical practice, the TTM may be used to obtain an indication of the treatment preference of an individual patient and may also be helpful to detect patients' motives to choose one treatment over another.