One-stop-shop with confocal microscopy imaging vs. standard care for surgical treatment of basal cell carcinoma: an open-label, noninferiority, randomized controlled multicentre trial
| Autor: | D.J. Kadouch, Y.S. Elshot, B. Zupan‐Kajcovski, A.S.E. Haersma de With, A.C. Wal, M. Leeflang, K. Jóźwiak, A. Wolkerstorfer, M.W. Bekkenk, P.I. Spuls, M.A. Rie |
|---|---|
| Přispěvatelé: | Dermatology, Cancer Center Amsterdam, Graduate School, CCA - Cancer Treatment and Quality of Life, Amsterdam Cardiovascular Sciences, Pathology, APH - Methodology, Epidemiology and Data Science, Other Research, APH - Quality of Care, APH - Personalized Medicine, ACS - Heart failure & arrhythmias, CCA - Cancer Treatment and quality of life |
| Jazyk: | angličtina |
| Rok vydání: | 2017 |
| Předmět: |
Adult
Male medicine.medical_specialty Skin Neoplasms Dermatology law.invention 030207 dermatology & venereal diseases 03 medical and health sciences 0302 clinical medicine Patient satisfaction Standard care Randomized controlled trial law medicine Carcinoma Humans Basal cell carcinoma Surgical treatment Aged Aged 80 and over Microscopy Confocal business.industry Margins of Excision Middle Aged medicine.disease Confidence interval Surgery Equivalence Trial Carcinoma Basal Cell Patient Satisfaction 030220 oncology & carcinogenesis Feasibility Studies Female business |
| Zdroj: | British journal of dermatology, 177(3), 735-741. Wiley-Blackwell British Journal of Dermatology, 177(3), 735-741. Wiley-Blackwell Kadouch, D J, Elshot, Y S, Zupan-Kajcovski, B, van Haersma de With, A S E, van der Wal, A C, Leeflang, M, Jóźwiak, K, Wolkerstorfer, A, Bekkenk, M W, Spuls, P I & de Rie, M A 2017, ' One-stop-shop with confocal microscopy imaging vs. standard care for surgical treatment of basal cell carcinoma : an open-label, noninferiority, randomized controlled multicentre trial ', British Journal of Dermatology, vol. 177, no. 3, pp. 735-741 . https://doi.org/10.1111/bjd.15559 |
| ISSN: | 0007-0963 |
| DOI: | 10.1111/bjd.15559 |
| Popis: | SummaryBackground Routine punch biopsies are considered to be standard care for diagnosing and subtyping basal cell carcinoma (BCC) when clinically suspected. Objectives We assessed the efficacy of a one-stop-shop concept using in vivo reflectance confocal microscopy (RCM) imaging as a diagnostic tool vs. standard care for surgical treatment in patients with clinically suspected BCC. Methods In this open-label, parallel-group, noninferiority, randomized controlled multicentre trial we enrolled patients with clinically suspected BCC at two tertiary referral centres in Amsterdam, the Netherlands. Patients were randomly assigned to the RCM one-stop-shop (diagnosing and subtyping using RCM followed by direct surgical excision) or standard care (planned excision based on the histological diagnosis and subtype of a punch biopsy). The primary outcome was the proportion of patients with tumour-free margins after surgical excision of BCC. Results Of the 95 patients included, 73 (77%) had a BCC histologically confirmed using a surgical excision specimen. All patients (40 of 40, 100%) in the one-stop-shop group had tumour-free margins. In the standard-care group tumour-free margins were found in all but two patients (31 of 33, 94%). The difference in the proportion of patients with tumour-free margins after BCC excision between the one-stop-shop group and the standard-care group was −0·06 (90% confidence interval −0·17−0·01), establishing noninferiority. Conclusions The proposed new treatment strategy seems suitable in facilitating early diagnosis and direct treatment for patients with BCC, depending on factors such as availability of RCM, size and site of the lesion, patient preference and whether direct surgical excision is feasible. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|
Plný text