Impact of a Surgical Sealing Patch on Lymphatic Drainage After Axillary Dissection for Breast Cancer: The SAKK 23/13 Multicenter Randomized Phase III Trial.

Autor: Weber WP; Breast Center, University Hospital Basel, University of Basel, Basel, Switzerland. walter.weber@usb.ch., Tausch C; Breast Center Zürich, Zurich, Switzerland., Hayoz S; SAKK Coordinating Center, Bern, Switzerland., Fehr MK; Cantonal Hospital Frauenfeld, Frauenfeld, Switzerland., Ribi K; SAKK Coordinating Center, Bern, Switzerland.; IBCSG Coordinating Center, Bern, Switzerland., Hawle H; SAKK Coordinating Center, Bern, Switzerland., Lupatsch JE; Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland., Matter-Walstra K; Institute of Pharmaceutical Medicine, University of Basel, Basel, Switzerland., Chiesa F; Breast Center Zürich, Zurich, Switzerland.; Breast Center St. Gallen, Cantonal Hospital St. Gallen, St. Gallen, Switzerland., Dedes KJ; Breast Cancer Center, Comprehensive Cancer Center Zurich, University Hospital of Zurich, Zurich, Switzerland., Berclaz G; Breast Center Bern Lindenhofgruppe, Bern, Switzerland., Lelièvre L; Centre du sein, Centre Hospitalier Universitaire Vaudois - CHUV, Lausanne, Switzerland., Hess T; Cantonal Hospital Winterthur, Winterthur, Switzerland., Güth U; Breast Center Zürich, Zurich, Switzerland.; Cantonal Hospital Winterthur, Winterthur, Switzerland., Pioch V; ZeTuP St. Gallen, St. Gallen, Switzerland., Sarlos D; Cantonal Hospital Aarau, Aarau, Switzerland., Leo C; Cantonal Hospital Baden, Baden, Switzerland., Canonica C; IOSI Bellinzona, Bellinzona, Switzerland., Gabriel N; City Hospital Triemli, Zurich, Switzerland., Zeindler J; Breast Center, University Hospital Basel, University of Basel, Basel, Switzerland., Cassoly E; SAKK Coordinating Center, Bern, Switzerland., Andrieu C; SAKK Coordinating Center, Bern, Switzerland., Soysal SD; Breast Center, University Hospital Basel, University of Basel, Basel, Switzerland., Ruhstaller T; Breast Center St. Gallen, Cantonal Hospital St. Gallen, St. Gallen, Switzerland., Fehr PM; Breast Center Graubünden, Cantonal Hospital Graubünden, Chur, Switzerland., Knauer M; Breast Center St. Gallen, Cantonal Hospital St. Gallen, St. Gallen, Switzerland.
Jazyk: angličtina
Zdroj: Annals of surgical oncology [Ann Surg Oncol] 2018 Sep; Vol. 25 (9), pp. 2632-2640. Date of Electronic Publication: 2018 Jun 08.
DOI: 10.1245/s10434-018-6556-9
Abstrakt: Background: Several studies and a meta-analysis showed that fibrin sealant patches reduced lymphatic drainage after various lymphadenectomy procedures. Our goal was to investigate the impact of these patches on drainage after axillary dissection for breast cancer.
Methods: In a phase III superiority trial, we randomized patients undergoing breast-conserving surgery at 14 Swiss sites to receive versus not receive three large TachoSil ® patches in the dissected axilla. Axillary drains were inserted in all patients. Patients and investigators assessing outcomes were blinded to group assignment. The primary endpoint was total volume of drainage.
Results: Between March 2015 and December 2016, 142 patients were randomized (72 with TachoSil ® and 70 without). Mean total volume of drainage in the control group was 703 ml [95% confidence interval (CI) 512-895 ml]. Application of TachoSil ® did not significantly reduce the total volume of axillary drainage [mean difference (MD) -110 ml, 95% CI -316 to 94, p = 0.30]. A total of eight secondary endpoints related to drainage, morbidity, and quality of life were not improved by use of TachoSil ® . The mean total cost per patient did not differ significantly between the groups [34,253 Swiss Francs (95% CI 32,625-35,880) with TachoSil ® and 33,365 Swiss Francs (95% CI 31,771-34,961) without, p = 0.584]. In the TachoSil ® group, length of stay was longer (MD 1 day, 95% CI 0.3-1.7, p = 0.009), and improvement of pain was faster, although the latter difference was not significant [2 days (95% CI 1-4) vs. 5.5 days (95% CI 2-11); p = 0.2].
Conclusions: TachoSil ® reduced drainage after axillary dissection for breast cancer neither significantly nor relevantly.
Databáze: MEDLINE
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