The intraoperative accuracy of maxillary balloon dilation: a blinded trial.

BACKGROUND: Balloon sinus dilation (BSD) is a commonly performed sinus procedure in the United States. Several cadaveric studies have evaluated BSD accuracy and the maxillary sinus has consistently been shown to be the most challenging to cannulate. We designed an independent study to evaluate the intraoperative accuracy of maxillary sinus BSD. METHODS: A prospective, single-blinded trial evaluating the accuracy of maxillary sinus BSD was performed using 2 commercially available BSD systems (guidewire- and probe-based systems) randomly assigned to patients undergoing endoscopic surgery for chronic rhinosinusitus without nasal polyps (CRSsNP) or a skullbase approach in patients without sinus disease. All patients underwent maxillary BSD followed by uncinectomy to reveal dilation of the natural maxillary sinus ostia. The recorded procedures were reviewed by 3 fellowship-trained rhinologists from different institutions blinded to the BSD system utilized. The primary endpoint compared accuracy of maxillary BSD attempts. The secondary endpoint compared accuracy between the 2 systems. RESULTS: Twenty-nine maxillary BSD procedures were performed in 18 patients (age range, 20-79 years; mean, 51 years) without nasal polyposis undergoing maxillary antrostomy as part of a more extensive procedure. BSD was successful in 18 of 29 (62%) attempts and unsuccessful in 9 of 29 (31%) attempts, with statistically "almost perfect" interrater agreement (kappa = 0.86). There was no statistical difference between the 2 BSD systems (p = 0.81). CONCLUSION: Maxillary BSD appeared to be less accurate in living patients when compared with findings from previously published cadaver studies. There were no differences in accuracy between the probe- and guidewire-based systems. This is the first non-industry-sponsored study evaluating maxillary sinus BSD in living patients. Further studies are needed to investigate the clinical implications of our findings.

Epithelial cell adhesion molecule-positive circulating tumor cells as predictive biomarker in patients with prostate cancer.

OBJECTIVE: To assess the use of circulating tumor cells (CTCs) as a longitudinal endpoint factor for clinical monitoring of patients with prostate cancer and to evaluate the association among the baseline CTC number, various clinical characteristics, and survival. MATERIALS AND METHODS: The CTCs were enumerated using the CellSearch Food and Drug Administration-cleared CTC kit in 202 patients with prostate cancer. Variables, including metastatic site, prostate-specific antigen level, Gleason score, testosterone level, and use of androgen treatment, were tested for association with the CTC number. The probability of patient survival over time was estimated using the Kaplan-Meier method. RESULTS: The baseline CTC numbers were strongly associated with survival (P <.0001), with overall survival significantly poorer in patients with ≥5 CTCs. Significantly greater CTC numbers were observed in patients with bone metastasis (mean 41.12 CTCs) than in those with lymph node metastasis (mean 2.53 CTC, P = .026). Analysis of the association between the CTC count and prostate-specific antigen level revealed a weak positive correlation (correlation coefficient r = 0.2695, P = .0007). The CTC number also correlated with the Gleason score (P = .0138) and lower testosterone level (P <.0001). Patients without androgen depletion had significantly lower CTC numbers (mean 2.70) than those with androgen depletion (mean 26.39, P <.0001). CONCLUSION: The baseline CTC counts were predictive of patient survival and correlated significantly with the clinical characteristics of patients with prostate cancer. Our study results have confirmed previous findings that support the use of CTC enumeration as a prognostic biomarker for patients with prostate cancer.

Acetazolamide 125 mg BD is not significantly different from 375 mg BD in the prevention of acute mountain sickness: the prophylactic acetazolamide dosage comparison for efficacy (PACE) trial.

750 mg per day of acetazolamide in the prevention of acute mountain sickness (AMS), as recommended in the meta-analysis published in 2000 in the British Medical Journal, may be excessive and is controversial. To determine if the efficacy of low-dose acetazolamide 125 mg bd (250 mg), as currently used in the Himalayas, is significantly different from 375 mg bd (750 mg) of acetazolamide in the prevention of AMS, we designed a prospective, double-blind, randomized, placebo-controlled trial. The participants were sampled from a diverse population of (non-Nepali) trekkers at Namche Bazaar (3440 m) in Nepal on the Everest trekking route as they ascended to study midpoints (4280 m/4358 m) and the endpoint, Lobuje (4928 m), where data were collected. Participants were randomly assigned to receive 375 mg bd of acetazolamide (82 participants), 125 mg bd of acetazolamide (74 participants), or a placebo (66 participants), beginning at 3440 m for up to 6 days as they ascended to 4928 m. The results revealed that composite AMS incidence for 125 mg bd was similar to the incidence for 375 mg bd (24% vs. 21%, 95% confidence interval, -12.6%, 19.8%), in contrast to significantly greater AMS (51%) observed in the placebo group (95% confidence interval for differences: 8%, 46%; 12%, 49% for low and high comparisons, respectively). Both doses of acetazolamide improved oxygenation equally (82.9% for 250 mg daily and 82.8% for 750 mg daily), while placebo endpoint oxygen saturation was significantly less at 80.7% (95% confidence interval for differences: 0.5%, 3.9% and 0.4%, 3.7% for low and high comparisons, respectively). There was also more paresthesia in the 375-mg bd group (p < 0.02). We conclude that 125 mg bd of acetazolamide is not significantly different from 375 mg bd in the prevention of AMS; 125 mg bd should be considered the preferred dosage when indicated for persons ascending to altitudes above 2500 m.