Chan, JYK

Chiu, PWY

Holsinger, FC

Ng, SSM

Tong, MCF

Tsang, RKY

Wong, EWY

European Archives of Oto-Rhino-Laryngology

HKU Scholars Hub

Title Early results of a safety and feasibility clinical trial of a novelsingle-port flexible robot for transoral robotic surgeryAuthor(s) Chan, JYK; Wong, EWY; Tsang, RKY; Holsinger, FC; Tong, MCF;Chiu, PWY; Ng, SSMCitation European Archives of Oto-Rhino-Laryngology, 2017, v. 274 n. 11,p. 3993-3996Issued Date 2017URL http://hdl.handle.net/10722/245323RightsThe final publication is available at Springer viahttp://dx.doi.org/10.1007/s00405-017-4729-y; This work islicensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.Vol.:(0123456789) Eur Arch Otorhinolaryngol (2017) 274:3993–3996 DOI 10.1007/s00405-017-4729-yHEAD AND NECKEarly results of a safety and feasibility clinical trial of a novel single‑port flexible robot for transoral robotic surgeryJason Y. K. Chan1  · Eddy W. Y. Wong1 · Raymond K. Tsang2 · F. Christopher Holsinger3 · Michael C. F. Tong1 · Philip W. Y. Chiu4 · Simon S. M. Ng4 Received: 21 July 2017 / Accepted: 22 August 2017 / Published online: 4 September 2017 © The Author(s) 2017. This article is an open access publicationKeywords Flexible robot · Transoral robotic surgery, TORS · da Vinci · Clinical trial · TransoralIntroductionSince the first description of a novel, flexible, single-arm robotic surgical system (da Vinci SP Surgical system, Model SP999; Intuitive Surgical Inc.) was first evaluated clinically in 2010 on 19 patients undergoing urological surgery [1]. Further technical refinements have been developed in this robotic system with recent publications containing a detailed description of the current design of the robot and cadaveric applications in transoral robotic surgery (TORS) [2, 3]. In brief, this next generation system incorporates a stereoscopic binocular camera and three 6 mm flexible instruments in a cannula of 2.5 cm diameter. The flexible robotic arms allow the instruments to be deployed from the oral cavity to the nasopharynx, oropharynx, hypopharynx, and larynx. Here, we describe the early results of the first ever clinical investi-gation into the feasibility and safety of this updated flexible single-arm robot, da Vinci SP (Intuitive Surgical Inc.), in TORS.MethodsStudy designThis was a prospective institutional review board approved, innovation, development, exploration, assessment, long-term study (IDEAL) phase 1 clinical trial conducted in accord-ance with the Declaration of Helsinki under the institutional review board and local regulatory body approval of The Abstract The aim of this study was to describe the early results of a phase 1 safety and feasibility clinical trial of the first clinical use of a novel robot for transoral robotic surgery (TORS)—the da Vinci SP (Intuitive Surgical Inc., Sunny-vale, CA, USA). Study design of this study is prospective clinical trial. The methods used in this study are prospective innovation, development, exploration, assessment, and long-term study phase 1 clinical trial. Early results of six patients underwent TORS with the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA, USA) demonstrate access the naso-pharynx, oropharynx, larynx, and hypopharynx. There were no conversions of the robotic surgical system. There were no serious adverse events or adverse events related to the use of the robot at 30-day follow-up for all six patients. The early results of this safety and feasibility trial of the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA, USA) clearly demonstrate that the device is safe and that it is feasible in performing TORS to access the nasopharynx, oropharynx, larynx, and hypopharynx.Electronic supplementary material The online version of this article (doi:10.1007/s00405-017-4729-y) contains supplementary material, which is available to authorized users. * Jason Y. K. Chan  jasonchan@ent.cuhk.edu.hk1 Department of Otorhinolaryngology, Head and Neck Surgery, Prince of Wales Hospital, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR, China2 Department of Surgery, The University of Hong Kong, Pok Fu Lam, Hong Kong SAR, China3 Department of Otorhinolaryngology, Head and Neck Surgery, Stanford University, Palo Alto, USA4 Department of Surgery, The Chinese University of Hong Kong, Shatin, N.T., Hong Kong SAR, China3994 Eur Arch Otorhinolaryngol (2017) 274:3993–39961 3Chinese University of Hong Kong. The study was registered on http://www.ClinicalTrials.gov (NCT03010813).Study populationBoth benign and malignant lesions of the head and neck were included with the first six cases, as shown in Table 1.Study endpointsPrimary endpoint included conversion rates and periopera-tive complications within 30 days following surgery. Sec-ondary endpoints included operative time, blood loss, and pain scores as documented with a visual analogue scale.Statistical analysisThe Fisher’s exact test and Mann–Whitney U test will be used to compare categorical, and non-parametric data for the trial. A p value <0.05 was considered to be statistically significant.ResultsAmong the first six enrolled patients, there were no con-versions to alternative surgical approaches. Figures 1, 2 show the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA) being utilized in case 3 to examine the larynx (Sup-plementary video 1). The procedures underwent are listed in Table 1, demonstrating that with the da Vinci SP (Intui-tive Surgical Inc., Sunnyvale, CA, USA) we could reach the nasopharynx, oropharynx, hypopharynx, and larynx utiliz-ing even just a simple daily Crowe–Davis retractor. The main use of time was in obtaining adequate exposure with the initial use of the da Vinci SP (Intuitive Surgical Inc., Sun-nyvale, CA, USA), mean 21.3 min (range 4–43 min). The initial time to dock the robot was negligible with a mean of 3.3 min (range 1–5 min). There were no conversions of the robotic surgical system. Mean visual analogue scale pain scores preoperatively, at 2 week and 30 day postop, were 0.16 (range 0–1), 0.67 (range 0–4), and 0.16 (range 0–1). There were no serious adverse events or adverse events related to the use of the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA, USA). There were surgical complications in two patients unrelated to the robot use. Case number four, a patient who had previous radiotherapy and poor dentition had a fractured right lower molar that required a dental con-sultation. Case number five had a 1 cm laceration of the tongue from the mouthgag that resolved by itself on follow-up visits. Table 1  Demographics, diagnosis, and procedure of the first six cases for transoral robotic surgery utilizing the da Vinci SPM male, F female, SCC squamous cell carcinoma, OP oropharynx, NP nasopharynx, CD Crowe–Davis, FK Feyh–KastenbauerCaseGenderAgePrevious radiother-apyDiagnosisProcedureRetractorTime to exposure (min)Time to dock robot (min)Estimated blood loss (ml)1M72YesTongue base papillomaTORS excision of the tongue baseCD16352F52YesSecond primary T1 oropharyngeal SCCTORS examination under anaesthesia of the OP and NPDingman10453M53YesRecurrent T2 Supraglottic CarcinomaTORS examination under anaesthesia of the larynxCD43104M75YesPharyngeal strictureTORS dilatation of pharyngeal strictureCD43105M64NoSupraglottic inflammatory massTORS excision of supraglottisFK355506M54NoUnknown primary SCC, P16 +veTORS excision of the tongue baseCD204203995Eur Arch Otorhinolaryngol (2017) 274:3993–3996 1 3DiscussionThe early results of this safety and feasibility trial of the da Vinci SP (Intuitive Surgical Inc., Sunnyvale, CA, USA) clearly demonstrate that the device is safe and that it is fea-sible in performing transoral surgery to access the nasophar-ynx, oropharynx, larynx, and hypopharyngeal region. This has been achieved in a predominantly Southern Chinese pop-ulation despite significantly different, in particular smaller cranio-facial measurements as compared to Caucasians [4].A significant advantage offered by the da Vinci SP (Intui-tive Surgical Inc., Sunnyvale, CA, USA) is the option to use three instruments to perform transoral endoscopic surgery. The working space within the instruments and camera is roughly the size of a tennis ball. This third arm replaces the need of an assistant to provide traction and counter traction and allows the surgeon to control these maneuvers to better dissect critical neurovascular structures. Other distinct advantages include the flexible camera enabled with digital zoom that allows magni-fication and easier visualization of lesions and the different compartments of the pharynx.There are some limitations to the system; now, with the extra arm, there is less working space for an assistant to, in particular, aid with suction. However, this can be largely over-come with a suction catheter placed through the nasal cavity into the desired location. Another limitation is the lack of bone instrumentation to resect, in particular tumors of the nasophar-ynx and skull base.ConclusionThe early results of the use of the novel single-port flexible robotic system, the da Vinci SP (Intuitive Surgical Inc., Sun-nyvale CA, USA) demonstrate that the device is safe and fea-sible to use for TORS to access the nasopharynx, oropharynx, larynx, and hypopharynx.Acknowledgements The authors acknowledge Paul Lilagan, Michael Ikeda, Christie Draper, Melanie Yuan, Holly Liske, and the da Vinci SP Engineering Team.Compliance with ethical standards Funding Jason Y. K. Chan, Eddy W. Y. Wong, Raymond K. Tsang, and Simon S. M. Ng received travel grants from Intuitive Surgical, Inc.Conflicts of interest The author declares that there is no competing interest.Ethical approval The study was approved by the Joint Chinese Uni-versity of Hong Kong—New Territories East Cluster Clinical Research ethics committee. The study was conducted in accordance with the Decla-ration of Helsinki. The study was registered on http://www.ClinicalTrials.gov (NCT03010813).Informed consent Informed consent was obtained from all individual participants included in the study.Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://crea-tivecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appro-priate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.  References 1. Kaouk JH, Haber GP, Autorino R et al (2014) A novel robotic sys-tem for single-port urologic surgery: first clinical investigation. Eur Urol 66(6):1033–1043Fig. 1  da Vinci SP in use for examination of the supraglottis with the camera arm and all three instrument arms deployed transorally as seen in the insetted figure. The mouth is opened and suspended with a Crowe–Davis mouthgag. The cannula is located about 10 cm from the oral openingFig. 2  da Vinci SP in use for examination of the supraglottis through an internal view. The monopolar spatula tip is seen on the left, the Maryland bipolars are opened at the right aryepiglottic fold expos-ing the tumor, while the fenestrated bipolar is retracting the epiglottis superiorly. The insetted figure shows the assistant holding a Yankaur suction and the location of the port about 10 cm from the oral opening3996 Eur Arch Otorhinolaryngol (2017) 274:3993–39961 3 2. Holsinger FC (2016) A flexible, single-arm robotic surgical sys-tem for transoral resection of the tonsil and lateral pharyngeal wall: next-generation robotic head and neck surgery. Laryngoscope 126(4):864–869 3. Tsang RK, Holsinger FC (2016) Transoral endoscopic nasophar-yngectomy with a flexible next-generation robotic surgical system. Laryngoscope 126(10):2257–2262 4. Lee RW, Vasudavan S, Hui DS et al (2010) Differences in crani-ofacial structures and obesity in caucasian and Chinese patients with obstructive sleep apnea. Sleep 33(8):1075–1080

Early results of a safety and feasibility clinical trial of a novel single-port flexible robot for transoral robotic surgery

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Early results of a safety and feasibility clinical trial of a novel single-port flexible robot for transoral robotic surgery

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