New for Old–Coagulum Lithotomy vs a Novel Bioadhesive for Complete Removal of Stone Fragments in a Comparative Study in an Ex Vivo Porcine Model
Abstract
Objectives: To evaluate a recently reported new bioadhesive system for the retrieval of small residual fragments (RFs) after intracorporeal lithotripsy, we systematically compared this system with coagulum lithotomy in retrograde intrarenal surgery.
Materials and Methods: We extracted 30 human stone fragments (≤1 mm) in an ex vivo porcine kidney model using a flexible ureteroscope for three groups: (1) the novel bioadhesive, (2) autologous blood as a natural adhesive, and (3) (control group) a conventional retrieval basket. Each group consisted of 15 test runs. Outcomes were evaluated regarding the macroscopic stone-free rate (SFR), retrieval time, and number of ureteral passages.
Results: For groups 1 and 2, a significant advantage in stone clearance, mean retrieval time, and number of retrievals was detected compared to the control group (p = 0.001). The time and number of retrievals were significantly lower in group 1 (10:36 minutes, p = 0.001) than in group 2 (26:12 minutes, p = 0.001), with shorter clotting time and better visibility.
Conclusions: These data show the general feasibility of intrarenal RF embedding to improve the SFR. Our data furthermore suggest the superiority of the artificial bioadhesive embedding agent over the application of native blood. Further in vivo studies and other research are necessary to confirm the adhesive's effect in patients.
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Copyright 2017, Mary Ann Liebert, Inc.
History
Published in print: June 2017
Published online: 1 June 2017
Published ahead of print: 8 May 2017
Published ahead of production: 6 April 2017
Topics
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Authors’ Contribution
D.S.S., protocol/project development, assisted surgery in ex vivo model, data collection and management, data analysis, and article and figure writing/editing. M.S., data analysis, article editing, and assisted surgery. D.S., article editing and assisted surgery. R.P., article editing and assisted surgery. M.B., article editing, assisted surgery. K.R., protocol/project development and developed chemical composition. I.G., protocol/project development and developed chemical composition. U.W., data analysis and supervision. A.M., protocol/project development and article and figure writing/editing, supervision. S.H., protocol/project development, article and figure writing/editing, supervision, and performed surgery in ex vivo model.
Author Disclosure Statement
M.S., consultant contract with Schoelly GmbH, Denzlingen, Germany, and NeoTract, Inc., Pleasanton, USA (both unrelated to this work). U.W., advisory board, Dr. Kade Pharmazeutische Fabrik GmbH, Berlin, Germany (unrelated to this work). A.M., consultant contract with Schoelly GmbH, Denzlingen, Germany (unrelated to this work). In addition, M.S., A.M., I.G., and K.R. hold the patents AU002013387207A1, CA000002910164A1, CN000105283140A, EP000002988682A1, EP000002796101B1, EP000002796101A1, KR102016004322A, US020160074561A1, and WO002014173468A1, all issued to the Albert Ludwig University of Freiburg and the Fraunhofer Society for the Advancement of Applied Research and covering the technology of the novel bioadhesive system reported in this study. None of the other authors has any conflict of interest or financial ties to disclose.
Ethical Approval
The study was approved by our local ethics committee and was therefore performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki and its later amendments. All participants gave their informed consent to provide stone material prior to their inclusion in the study. Number 296/15, Ethics Committee of the University Medical Center Freiburg.
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