Feasibility study of robot-assisted endoscopic retrograde cholangiopancreatography for biliary stent placement in an in vivo porcine model

Feasibility study of robot-assisted endoscopic retrograde cholangiopancreatography for biliary stent placement in an in vivo porcine model | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Feasibility study of robot-assisted endoscopic retrograde cholangiopancreatography for biliary stent placement in an in vivo porcine model Zhijie Wang, Lei Lu, Hao Wu, Xuanhua Chen, Qifeng Lou, Weigang Gu, and 4 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6983888/v2 This work is licensed under a CC BY 4.0 License Status: Posted Version 2 posted You are reading this latest preprint version Show more versions Abstract Background ERCP is an advanced endoscopic technique that involves fluoroscopy, and as such it may pose a risk of occupational radiation exposure for medical personnel. This technique also places high demands on the operator's hand dexterity and stability due to its significant technical complexity. Methods To address these issues, we developed a robotic system named “Qifengda” to assist in ERCP procedures. A novel robotic system for flexible endoscopy was developed in this study, and its feasibility for assisting endoscopists in ERCP procedures was evaluated in a porcine model. Results Successful cannulation, cholangiography, and biliary stent placement were performed using this robotic system, without any significant procedure-related adverse events. Discussion This preclinical pilot study supports proof-of-concept of this robotic endoscopic system for assisting endoscopists in ERCP procedures. In future studies, we will further validate the feasibility and safety of this system in human subjects. Robotics Animal Science Gastroenterology & Hepatology ERCP robot flexible endoscopy animal model adverse event Figures Figure 1 Figure 2 Figure 3 Introduction Endoscopic retrograde cholangiopancreatography (ERCP) represents one of the most advanced endoscopic techniques with constantly expanding diagnostic and therapeutic applications. However, due to the complexity of the procedure, along with its associated risks, ERCP requires delicate manipulation, demanding a high level of dexterity and stability from the operator's hands, which makes it difficult to attain ERCP competency. Furthermore, the use of cumbersome protective gear substantially amplifies the physical strain on endoscopists and fails to fully alleviate concerns over occupational radiation exposure during this radiation-intensive procedure. To address these issues, we developed a novel robotic endoscopic system named “Qifengda” and aimed to establish proof-of-concept for robot-assisted ERCP procedures in a porcine model. Procedure The “Qifengda” system (Shanghai Operation Robot Co., Ltd, China) is a robotic manipulator for flexible endoscopy. This system, structured around a physician-assistant collaborative paradigm, integrates three primary components: a master control console, a bedside mechanical assistant unit, and an accessory support unit. First, the master control console (Fig. 1 A), is primarily composed of three components: the endoscope control module, the accessory control module, and the main monitor screen. The endoscope control module (without the function of advancing or withdrawing the endoscope) includes an operation handle designed to mimic a standard endoscope handle to minimize the learning curve (Fig. 1 B), along with a touch-control screen (Fig. 1 C). The endoscope can be effectively controlled through either the operation handle or the touch-control screen. The accessory control module, which is designed to perform the assistant’s tasks, consists of a joystick for controlling the directional movement of endoscopic accessories, a foot pedal controller for managing the exchange of accessories or guidewire delivery (Fig. 1 D), and a small monitor screen for observing the status of accessories and configuring relevant parameters (Fig. 1 E). Notably, the system incorporates haptic feedback capability. During the advancement of accessories such as guidewires, operators can perceive resistance encountered in real time through the joystick, while quantified resistance values are displayed on the touch-control screen. The main monitor screen, which simultaneously offers endoscopic view, fluoroscopic view, as well as of view of the robotic system and the experimental subject, is used to monitor the ERCP procedure in real time. Second, the bedside mechanical assistant unit is responsible for executing commands from the master control console (Fig. 2 A). It consists of two primary components: one component is equipped with a groove and fasteners for docking and controls standard endoscope handle (Fig. 2 B), while the other is connected to the accessory support unit and manages the movement of accessories via a robotic arm (Fig. 2 C). The accessory support unit is used to accommodate and carry various endoscopic accessories and syringes for contrast agent injection (Fig. 2 D). Following a 12-hour fasting period, a live male pig ( Sus scrofa domesticus , Landrace) was intubated with an endotracheal tube and connected to an anesthesia workstation after general anesthesia induction. Then, the robot-assisted ERCP procedure for in vivo biliary stent placement was performed by a senior endoscopist (XF.Z.) with experience of more than 3000 cases of ERCP. The protocol of animal experiment was reviewed and approved by the Committee on Ethics of Medicine of Shanghai Mincal Medical Research Co., Ltd. Large Animal Research Center (NO. [2022]08 − 04). Result Initially, the duodenoscope (JF260, Olympus, Japan) was manually introduced through the mouth and advanced to the major duodenal papilla. The duodenoscope handle was then loaded into the bedside mechanical assistant unit. The planned or potentially required accessories such as bile duct stents and sphincterotome, were pre-installed. After preparing the operating room for the robot-assisted procedure, the operator entered the adjacent control room, where they proceeded to perform the subsequent procedures via the master control console (Fig. 3 A). The operator could perform endoscope manipulation, elevator control, injection/suction of carbon dioxide and water, advancement/retraction of guidewires and catheters, and instrument exchange through the coordinated use of the operation handle, joystick, and foot pedal controller. Following successful cannulation and biliary duct visualization via X-ray (Fig. 3 B), a plastic stent (7Fr, 12 cm) was successfully deployed into the common bile duct without sphincterotomy (Fig. 3 C). The procedure time was 30 minutes (from the insertion of endoscope to the end of successful stent placement). Finally, the experimental animal was euthanized, and the position of the stent was re-confirmed via postmortem examination (Fig. 3 D). No significant procedure-related damage to the gastrointestinal tract, biliary tract, or liver was observed (Fig. 3 E). Discussion As a radiation-intensive procedure, ERCP subjects endoscopists and their assistants to radiation exposure, with cumulative risks raising significant concerns for practitioners performing hundreds of cases of ERCP annually. While the International Atomic Energy Agency underscores the importance of protective devices and best practices, a survey from South Korea has shown poor compliance or insufficient awareness of radiation protection among endoscopists [ 1 ] . Beyond the use of protective aprons, the adoption of additional protective measures, such as thyroid guards, protective glasses, or personal dosimeters is comparatively less prevalent, which may increase cataract risk or lead to cancer or genetic mutations due to the stochastic effect even at relatively low dosages [ 2 , 3 ] . A freedom of information request has revealed only 5% of the ERCP workforce in the UK is female [ 4 ] . Another nationwide survey also identified significant gender disparities with females comprising merely 29% of ERCP trainees, whereas gender distribution was balanced in non-hepatobiliary therapeutic endoscopy [ 5 ] . Over half of female respondents have acknowledged radiation exposure as a significant determinant influencing their participation in ERCP training [ 5 ] . The preliminary results of this in vivo animal study support proof-of-concept for robot-assisted ERCP procedures, initially displaying satisfactory manipulative performance. However, further research is needed to validate the feasibility and safety of the proposed robotic system in more animal models and human subjects. Nevertheless, once fully developed, this robotic system is expected to mitigate or even eliminate the risk of radiation exposure for endoscopists, which may also substantially enhance female practitioners’ career engagement in this subspecialty. The robotic system, based on mechanical control, could potentially enable endoscopists to overcome hand tremors in the future, thereby enhancing the stability of delicate manipulations and reducing the risk of procedure-related complications. Furthermore, due to equipped sensors that monitor resistance during procedures, operative safety is enhanced through the integration of real-time haptic feedback along with continuous data visualization, and preset safety thresholds, which prevent excessive manipulation. This study has several limitations. First, as a single-case preclinical proof-of-concept, the reproducibility and scientific rigor need to be further enhanced. For example, the bile and pancreatic ducts open separately in pigs, whereas in humans they share a common orifice. This difference implies that more delicate endoscopic manipulation will be required to achieve successful bile duct cannulation in humans. Second, it is difficult to quantify the benefits of robotic assistance in this study, since there is no comparison with conventional manual ERCP. At last, histologic tissue assessment was not performed in this study, which may have led to the oversight of some potential procedure-related injuries in gastrointestinal tract, liver or bile ducts. In conclusion, the above results of our preclinical animal model study support proof-of-concept for the proposed robotic endoscopic system, which could be used in assisting endoscopists in ERCP procedures. This technology may herald a paradigm shift in interventional endoscopy, addressing both technical and occupational health challenges in ERCP practice. In future studies, we will conduct human trials to rigorously evaluate the performance and safety of this robotic endoscopic system in clinical settings. Declarations Conflict of Interests The authors declare that they have no conflicts of interest with the contents of this article. Ethics Statement Approval of the research protocol (animal Studies) by the Committee on Ethics of Medicine of Shanghai Mincal Medical Research Co., Ltd. Large Animal Research Center (NO. [2022]08 − 04). Informed Consent: N/A. Funding Information This study was supported by The Construction Fund of Key Medical Disciplines of Hangzhou (OO20190001), Key R&D Program of Zhejiang Province (No.2023C03054, No.2024C03048), and Zhejiang Provincial Natural Science Foundation of China (No. LQN25H030008). Acknowledgments We thank the Large Animal Research Center of Shanghai Mincal Medical Research Co., Ltd. and Shanghai Operation Robot Co., Ltd. for their assistance and technical support during the experiment. We also thank LetPub ( www.letpub.com ) for its linguistic assistance during the preparation of this manuscript. References Son BK, Lee KT, Kim JS, Lee SO (2011) Lack of radiation protection for endoscopists performing endoscopic retrograde cholangiopancreatography. Korean J Gastroenterol 58(2):93–99 Oh CH, Son BK (2022) Minimizing radiation exposure in endoscopic retrograde cholangiopancreatography: a review for medical personnel. Korean J Intern Med 37(6):1111–1119 Ikezawa K, Hayashi S, Takenaka M, Yakushijin T, Nagaike K, Takada R et al (2023) Occupational radiation exposure to the lens of the eyes and its protection during endoscopic retrograde cholangiopancreatography. Sci Rep 13(1):7824 Sethi S, Kumar A, Clough J, Ravindran S, Harris R, Harvey P et al (2022) Women in gastroenterology: the UK trainee experience. Frontline Gastroenterol 13(6):484–489 Kotha S, Long M, Berry P (2025) Gender disparity in hepatobiliary endoscopy training and delivery: Results of a nationwide survey. Endosc Int Open 13:a25056019 Additional Declarations The authors declare no competing interests. Cite Share Download PDF Status: Posted Version 2 posted You are reading this latest preprint version Show more versions Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6983888","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":477304787,"identity":"33cbe48f-3e9f-403a-83e1-791851e4d680","order_by":0,"name":"Zhijie Wang","email":"","orcid":"https://orcid.org/0000-0001-8015-5413","institution":"Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, 310006, China","correspondingAuthor":false,"prefix":"","firstName":"Zhijie","middleName":"","lastName":"Wang","suffix":""},{"id":557061307,"identity":"87136554-0edd-4cd1-82dd-4c81f6e7810f","order_by":1,"name":"Lei Lu","email":"","orcid":"","institution":"Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, 310006, China","correspondingAuthor":false,"prefix":"","firstName":"Lei","middleName":"","lastName":"Lu","suffix":""},{"id":477304788,"identity":"e545e2eb-756a-4c23-bc7d-f53ebd8073e6","order_by":2,"name":"Hao Wu","email":"","orcid":"","institution":"Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, 310006, China","correspondingAuthor":false,"prefix":"","firstName":"Hao","middleName":"","lastName":"Wu","suffix":""},{"id":477304789,"identity":"660a69bb-84c9-448b-8645-d77a164632df","order_by":3,"name":"Xuanhua Chen","email":"","orcid":"","institution":"Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, 310006, China","correspondingAuthor":false,"prefix":"","firstName":"Xuanhua","middleName":"","lastName":"Chen","suffix":""},{"id":477304790,"identity":"c99506ce-75d3-41c7-a2fe-3d337207462f","order_by":4,"name":"Qifeng Lou","email":"","orcid":"","institution":"Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, 310006, China","correspondingAuthor":false,"prefix":"","firstName":"Qifeng","middleName":"","lastName":"Lou","suffix":""},{"id":477304791,"identity":"1f92f01b-1194-4eef-9a6b-7e39d983e92b","order_by":5,"name":"Weigang Gu","email":"","orcid":"","institution":"Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, 310006, China","correspondingAuthor":false,"prefix":"","firstName":"Weigang","middleName":"","lastName":"Gu","suffix":""},{"id":477304792,"identity":"c292faab-39a1-4e63-908f-bb4605ba3135","order_by":6,"name":"Wencong Ma","email":"","orcid":"","institution":"Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, 310006, China","correspondingAuthor":false,"prefix":"","firstName":"Wencong","middleName":"","lastName":"Ma","suffix":""},{"id":477304793,"identity":"7c4b43d4-25dc-49b1-9dcb-b00ed7f986d9","order_by":7,"name":"Hangbin Jin","email":"","orcid":"","institution":"Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, 310006, China","correspondingAuthor":false,"prefix":"","firstName":"Hangbin","middleName":"","lastName":"Jin","suffix":""},{"id":477304794,"identity":"872ff869-97af-4323-81fb-4bb78e557944","order_by":8,"name":"Jianfeng Yang","email":"","orcid":"","institution":"Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, 310006, China","correspondingAuthor":false,"prefix":"","firstName":"Jianfeng","middleName":"","lastName":"Yang","suffix":""},{"id":477304795,"identity":"5857582c-6707-478f-9d9f-ff267a0086b4","order_by":9,"name":"Xiaofeng Zhang","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAvklEQVRIie3QsQrCQAyA4TsC1yXaNZ30EQIHnQp9EJcDoZvgA3QodHARuvo4hYCrL+DQLs72BcRbHeTOzeG+OT8kUSpJ/pKe5+U1qhxApsgErCUzquJkGo5NSkKf8A23FBVsLntgwnttBRWrttoFE30WPR3pAaWsxkldm0MXXCsbhInFlLJ2rDsJJwbAEDpB2yNTVIJZ75NRiCE2IRSwReeXE/9kF3OL/5iel07qfBCZnm0VTj6538aTJEmSb94qSjlf4RcOtwAAAABJRU5ErkJggg==","orcid":"","institution":"Department of Gastroenterology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, Zhejiang, 310006, China","correspondingAuthor":true,"prefix":"","firstName":"Xiaofeng","middleName":"","lastName":"Zhang","suffix":""}],"badges":[],"createdAt":"2025-06-26 13:32:15","currentVersionCode":2,"declarations":{"humanSubjects":false,"vertebrateSubjects":true,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":false,"humanSubjectConsent":false,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":true},"doi":"10.21203/rs.3.rs-6983888/v2","doiUrl":"https://doi.org/10.21203/rs.3.rs-6983888/v2","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":99837647,"identity":"415df4db-5e5c-41a1-b692-f1c7d1000927","added_by":"auto","created_at":"2026-01-08 19:50:02","extension":"docx","order_by":0,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":42222,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript20251108.docx","url":"https://assets-eu.researchsquare.com/files/rs-6983888/v2/f5931cf6139417d8aeeda505.docx"},{"id":99837648,"identity":"aadddd04-76d0-4375-a3ea-960650e64392","added_by":"auto","created_at":"2026-01-08 19:50:03","extension":"json","order_by":1,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":342,"visible":true,"origin":"","legend":"","description":"","filename":"rs6983888.json","url":"https://assets-eu.researchsquare.com/files/rs-6983888/v2/844ce6ccb0d9b1ef8df06aeb.json"},{"id":100357486,"identity":"6f8f5925-1c6f-4486-8396-0abf5b481e61","added_by":"auto","created_at":"2026-01-16 07:19:55","extension":"xml","order_by":2,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":27418,"visible":true,"origin":"","legend":"","description":"","filename":"rs69838881enriched.xml","url":"https://assets-eu.researchsquare.com/files/rs-6983888/v2/08abab8739c2e27c1c8d4e1d.xml"},{"id":99837650,"identity":"e8d41bb1-e083-40df-bb83-0f9454fd11de","added_by":"auto","created_at":"2026-01-08 19:50:03","extension":"xml","order_by":3,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":25533,"visible":true,"origin":"","legend":"","description":"","filename":"rs69838881structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-6983888/v2/4de8f25d494c73cf81263835.xml"},{"id":100356714,"identity":"866b8b69-06f4-4853-8c62-215df9448197","added_by":"auto","created_at":"2026-01-16 07:17:06","extension":"html","order_by":4,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":30731,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-6983888/v2/31327ae9b652106309355561.html"},{"id":99837652,"identity":"9a780b00-e88d-4c64-a764-439262b0436b","added_by":"auto","created_at":"2026-01-08 19:50:03","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":31830223,"visible":true,"origin":"","legend":"\u003cp\u003eThe overview of the master control console. (A) The overall structure of the master control console (the joystick for endoscopic accessories controlling is indicated by yellow arrow). (B) The operation handle for endoscope controlling, which designed to mimic a standard endoscope handle. (C) The touch-control screen for endoscope controlling. (D) The foot pedal controller for accessories controlling. (E) The small monitor screen for accessories management.\u003c/p\u003e","description":"","filename":"Figure1.png","url":"https://assets-eu.researchsquare.com/files/rs-6983888/v2/4c022bf2f759e70aa743b20c.png"},{"id":99837653,"identity":"9eeecdb9-be45-4955-80d0-244333c45a32","added_by":"auto","created_at":"2026-01-08 19:50:03","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":22626728,"visible":true,"origin":"","legend":"\u003cp\u003eThe overview of assistant part of robotic endoscopic system. (A) The overall structure of the bedside mechanical assistant unit (left) and the accessory driving unit (right). (B) Top view of the bedside mechanical assistant unit. (C) Side view of the accessory driving unit with a robotic arm. (D) The accessory support unit.\u003c/p\u003e","description":"","filename":"Figure2.png","url":"https://assets-eu.researchsquare.com/files/rs-6983888/v2/7a289102490e9149b799137a.png"},{"id":100356818,"identity":"e190c5ae-9024-4324-90cf-52db63834aa0","added_by":"auto","created_at":"2026-01-16 07:17:37","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":44197291,"visible":true,"origin":"","legend":"\u003cp\u003eThe procedure of robot-assisted ERCP for biliary stent placement. (A) User interface for human-robot interactions with a main console screen (left) and a touch-control screen (right). (B) Visualization of the biliary duct via X-ray after contrast agent injection. (C) Fluoroscopic view revealing successful placement of a plastic stent into the common bile duct. (D) Postoperative anatomical examination re-confirming the location of the stent (yellow arrow), and (E) revealing no significant procedure-related damage.\u003c/p\u003e","description":"","filename":"Figure3.png","url":"https://assets-eu.researchsquare.com/files/rs-6983888/v2/42b44eba4b0cdac6451ed0b8.png"},{"id":100380072,"identity":"e5aeeffe-665a-45a9-b500-67b8dc871ce8","added_by":"auto","created_at":"2026-01-16 10:18:31","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":93654340,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6983888/v2/aeaeeeb1-a086-4984-bb6c-b452ceab4bcc.pdf"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"Feasibility study of robot-assisted endoscopic retrograde cholangiopancreatography for biliary stent placement in an in vivo porcine model","fulltext":[{"header":"Introduction","content":"\u003cp\u003eEndoscopic retrograde cholangiopancreatography (ERCP) represents one of the most advanced endoscopic techniques with constantly expanding diagnostic and therapeutic applications. However, due to the complexity of the procedure, along with its associated risks, ERCP requires delicate manipulation, demanding a high level of dexterity and stability from the operator's hands, which makes it difficult to attain ERCP competency. Furthermore, the use of cumbersome protective gear substantially amplifies the physical strain on endoscopists and fails to fully alleviate concerns over occupational radiation exposure during this radiation-intensive procedure. To address these issues, we developed a novel robotic endoscopic system named \u0026ldquo;Qifengda\u0026rdquo; and aimed to establish proof-of-concept for robot-assisted ERCP procedures in a porcine model.\u003c/p\u003e"},{"header":"Procedure","content":"\u003cp\u003eThe “Qifengda” system (Shanghai Operation Robot Co., Ltd, China) is a robotic manipulator for flexible endoscopy. This system, structured around a physician-assistant collaborative paradigm, integrates three primary components: a master control console, a bedside mechanical assistant unit, and an accessory support unit.\u003c/p\u003e\u003cp\u003eFirst, the master control console (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eA), is primarily composed of three components: the endoscope control module, the accessory control module, and the main monitor screen. The endoscope control module (without the function of advancing or withdrawing the endoscope) includes an operation handle designed to mimic a standard endoscope handle to minimize the learning curve (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eB), along with a touch-control screen (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eC). The endoscope can be effectively controlled through either the operation handle or the touch-control screen. The accessory control module, which is designed to perform the assistant’s tasks, consists of a joystick for controlling the directional movement of endoscopic accessories, a foot pedal controller for managing the exchange of accessories or guidewire delivery (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eD), and a small monitor screen for observing the status of accessories and configuring relevant parameters (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003eE). Notably, the system incorporates haptic feedback capability. During the advancement of accessories such as guidewires, operators can perceive resistance encountered in real time through the joystick, while quantified resistance values are displayed on the touch-control screen. The main monitor screen, which simultaneously offers endoscopic view, fluoroscopic view, as well as of view of the robotic system and the \u003cem class=\"Highlight ht4fc55b9d-f515-4fa8-9e5d-6731d62f45ba\" highlight=\"true\" htmatch=\"experiment*\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003eexperimental\u003c/em\u003e subject, is used to monitor the ERCP procedure in real time.\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eSecond, the bedside mechanical assistant unit is responsible for executing commands from the master control console (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eA). It consists of two primary components: one component is equipped with a groove and fasteners for docking and controls standard endoscope handle (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eB), while the other is connected to the accessory support unit and manages the movement of accessories via a robotic arm (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eC). The accessory support unit is used to accommodate and carry various endoscopic accessories and syringes for contrast agent injection (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003eD).\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\u003cp\u003eFollowing a 12-hour fasting period, a live \u003cem class=\"Highlight ht29216696-c42e-4f00-932a-aea34347df6a\" highlight=\"true\" htmatch=\"male*\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003emale\u003c/em\u003e \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"pig\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003epig\u003c/em\u003e (\u003cem\u003eSus scrofa domesticus\u003c/em\u003e, Landrace) was intubated with an endotracheal tube and connected to an \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"anesth*\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003eanesthesia\u003c/em\u003e workstation after general \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"anesth*\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003eanesthesia\u003c/em\u003e induction. Then, the robot-assisted ERCP procedure for \u003cem\u003e\u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"in vivo\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003ein vivo\u003c/em\u003e\u003c/em\u003e biliary stent placement was performed by a senior endoscopist (XF.Z.) with experience of more than 3000 \u003cem class=\"Highlight ht71194251-f7a6-4c2d-a145-3d9f25b46662\" highlight=\"true\" htmatch=\"case*\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003ecases\u003c/em\u003e of ERCP. The protocol of \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"animal*\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003eanimal\u003c/em\u003e \u003cem class=\"Highlight ht4fc55b9d-f515-4fa8-9e5d-6731d62f45ba\" highlight=\"true\" htmatch=\"experiment*\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003eexperiment\u003c/em\u003e was reviewed and \u003cem class=\"Highlight htf340ff0d-a602-4893-ae8d-b60ea075e112\" highlight=\"true\" htmatch=\"approved\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003eapproved\u003c/em\u003e by the \u003cem class=\"Highlight htf340ff0d-a602-4893-ae8d-b60ea075e112\" highlight=\"true\" htmatch=\"committee\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003eCommittee\u003c/em\u003e on \u003cem class=\"Highlight htf340ff0d-a602-4893-ae8d-b60ea075e112\" highlight=\"true\" htmatch=\"ethic*\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003eEthics\u003c/em\u003e of Medicine of Shanghai Mincal Medical Research Co., Ltd. Large \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"animal*\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003eAnimal\u003c/em\u003e Research Center (NO. [2022]08 − 04).\u003c/p\u003e\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003cp\u003e\u003c/p\u003e\u003c/div\u003e"},{"header":"Result","content":"\u003cp\u003eInitially, the duodenoscope (JF260, Olympus, Japan) was manually introduced through the mouth and advanced to the major duodenal papilla. The duodenoscope handle was then loaded into the bedside mechanical assistant unit. The planned or potentially required accessories such as bile duct stents and sphincterotome, were pre-installed.\u003c/p\u003e\u003cp\u003eAfter preparing the operating room for the robot-assisted procedure, the operator entered the adjacent control room, where they proceeded to perform the subsequent procedures via the master control console (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eA). The operator could perform endoscope manipulation, elevator control, injection/suction of carbon dioxide and water, advancement/retraction of guidewires and catheters, and instrument exchange through the coordinated use of the operation handle, joystick, and foot pedal controller. Following successful cannulation and biliary duct visualization via X-ray (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eB), a plastic stent (7Fr, 12 cm) was successfully deployed into the common bile duct without sphincterotomy (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eC). The procedure time was 30 minutes (from the insertion of endoscope to the end of successful stent placement). Finally, the \u003cem class=\"Highlight ht4fc55b9d-f515-4fa8-9e5d-6731d62f45ba\" highlight=\"true\" htmatch=\"experiment*\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003eexperimental\u003c/em\u003e \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"animal*\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003eanimal\u003c/em\u003e was \u003cem class=\"Highlight ht2ecd8aa4-09dc-4ddc-8bb0-28c2efee0ea2\" highlight=\"true\" htmatch=\"euthanize*\" htloopnumber=\"450151691\" style=\"font-style: inherit;\"\u003eeuthanized,\u003c/em\u003e and the position of the stent was re-confirmed via postmortem examination (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eD). No significant procedure-related damage to the gastrointestinal tract, biliary tract, or liver was observed (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003eE).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eAs a radiation-intensive procedure, ERCP subjects endoscopists and their assistants to radiation exposure, with cumulative risks raising significant concerns for practitioners performing hundreds of cases of ERCP annually. While the International Atomic Energy Agency underscores the importance of protective devices and best practices, a survey from South Korea has shown poor compliance or insufficient awareness of radiation protection among endoscopists\u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]\u003c/sup\u003e. Beyond the use of protective aprons, the adoption of additional protective measures, such as thyroid guards, protective glasses, or personal dosimeters is comparatively less prevalent, which may increase cataract risk or lead to cancer or genetic mutations due to the stochastic effect even at relatively low dosages\u003csup\u003e[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e. A freedom of information request has revealed only 5% of the ERCP workforce in the UK is female\u003csup\u003e[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003e. Another nationwide survey also identified significant gender disparities with females comprising merely 29% of ERCP trainees, whereas gender distribution was balanced in non-hepatobiliary therapeutic endoscopy\u003csup\u003e[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/sup\u003e. Over half of female respondents have acknowledged radiation exposure as a significant determinant influencing their participation in ERCP training\u003csup\u003e[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eThe preliminary results of this \u003cem\u003ein vivo\u003c/em\u003e animal study support proof-of-concept for robot-assisted ERCP procedures, initially displaying satisfactory manipulative performance. However, further research is needed to validate the feasibility and safety of the proposed robotic system in more animal models and human subjects. Nevertheless, once fully developed, this robotic system is expected to mitigate or even eliminate the risk of radiation exposure for endoscopists, which may also substantially enhance female practitioners\u0026rsquo; career engagement in this subspecialty. The robotic system, based on mechanical control, could potentially enable endoscopists to overcome hand tremors in the future, thereby enhancing the stability of delicate manipulations and reducing the risk of procedure-related complications. Furthermore, due to equipped sensors that monitor resistance during procedures, operative safety is enhanced through the integration of real-time haptic feedback along with continuous data visualization, and preset safety thresholds, which prevent excessive manipulation.\u003c/p\u003e\u003cp\u003eThis study has several limitations. First, as a single-case preclinical proof-of-concept, the reproducibility and scientific rigor need to be further enhanced. For example, the bile and pancreatic ducts open separately in pigs, whereas in humans they share a common orifice. This difference implies that more delicate endoscopic manipulation will be required to achieve successful bile duct cannulation in humans. Second, it is difficult to quantify the benefits of robotic assistance in this study, since there is no comparison with conventional manual ERCP. At last, histologic tissue assessment was not performed in this study, which may have led to the oversight of some potential procedure-related injuries in gastrointestinal tract, liver or bile ducts.\u003c/p\u003e\u003cp\u003eIn conclusion, the above results of our preclinical animal model study support proof-of-concept for the proposed robotic endoscopic system, which could be used in assisting endoscopists in ERCP procedures. This technology may herald a paradigm shift in interventional endoscopy, addressing both technical and occupational health challenges in ERCP practice. In future studies, we will conduct human trials to rigorously evaluate the performance and safety of this robotic endoscopic system in clinical settings.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003ch2\u003eConflict of Interests\u003c/h2\u003e\u003cp\u003eThe authors declare that they have no conflicts of interest with the contents of this article.\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003ch2\u003eEthics Statement\u003c/h2\u003e\u003cp\u003eApproval of the research protocol (animal Studies) by the Committee on Ethics of Medicine of Shanghai Mincal Medical Research Co., Ltd. Large Animal Research Center (NO. [2022]08\u0026thinsp;\u0026minus;\u0026thinsp;04).\u003c/p\u003e\u003c/p\u003e\u003cp\u003e\u003ch2\u003eInformed Consent:\u003c/h2\u003e\u003cp\u003eN/A.\u003c/p\u003e\u003c/p\u003e\u003ch2\u003eFunding Information\u003c/h2\u003e\u003cp\u003eThis study was supported by The Construction Fund of Key Medical Disciplines of Hangzhou (OO20190001), Key R\u0026amp;D Program of Zhejiang Province (No.2023C03054, No.2024C03048), and Zhejiang Provincial Natural Science Foundation of China (No. LQN25H030008).\u003c/p\u003e\u003ch2\u003eAcknowledgments\u003c/h2\u003e\u003cp\u003eWe thank the Large Animal Research Center of Shanghai Mincal Medical Research Co., Ltd. and Shanghai Operation Robot Co., Ltd. for their assistance and technical support during the experiment. We also thank LetPub (\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e\u003ca href=\"http://www.letpub.com\" target=\"_blank\"\u003ewww.letpub.com\u003c/a\u003e\u003c/span\u003e\u003cspan address=\"http://www.letpub.com\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e) for its linguistic assistance during the preparation of this manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eSon BK, Lee KT, Kim JS, Lee SO (2011) Lack of radiation protection for endoscopists performing endoscopic retrograde cholangiopancreatography. Korean J Gastroenterol 58(2):93\u0026ndash;99\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eOh CH, Son BK (2022) Minimizing radiation exposure in endoscopic retrograde cholangiopancreatography: a review for medical personnel. Korean J Intern Med 37(6):1111\u0026ndash;1119\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eIkezawa K, Hayashi S, Takenaka M, Yakushijin T, Nagaike K, Takada R et al (2023) Occupational radiation exposure to the lens of the eyes and its protection during endoscopic retrograde cholangiopancreatography. Sci Rep 13(1):7824\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSethi S, Kumar A, Clough J, Ravindran S, Harris R, Harvey P et al (2022) Women in gastroenterology: the UK trainee experience. Frontline Gastroenterol 13(6):484\u0026ndash;489\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eKotha S, Long M, Berry P (2025) Gender disparity in hepatobiliary endoscopy training and delivery: Results of a nationwide survey. Endosc Int Open 13:a25056019\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"Department of Gastroenterology, Affiliated Hangzhou First People's Hospital,School of Medicine ,Westlake University","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"ERCP, robot, flexible endoscopy, animal model, adverse event","lastPublishedDoi":"10.21203/rs.3.rs-6983888/v2","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6983888/v2","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eERCP is an advanced endoscopic technique that involves fluoroscopy, and as such it may pose a risk of occupational radiation exposure for medical personnel. This technique also places high demands on the operator's hand dexterity and stability due to its significant technical complexity.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eTo address these issues, we developed a robotic system named \u0026ldquo;Qifengda\u0026rdquo; to assist in ERCP procedures. A novel robotic system for flexible endoscopy was developed in this study, and its feasibility for assisting endoscopists in ERCP procedures was evaluated in a porcine model.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eSuccessful cannulation, cholangiography, and biliary stent placement were performed using this robotic system, without any significant procedure-related adverse events.\u003c/p\u003e\u003ch2\u003eDiscussion\u003c/h2\u003e\u003cp\u003eThis preclinical pilot study supports proof-of-concept of this robotic endoscopic system for assisting endoscopists in ERCP procedures. In future studies, we will further validate the feasibility and safety of this system in human subjects.\u003c/p\u003e","manuscriptTitle":"Feasibility study of robot-assisted endoscopic retrograde cholangiopancreatography for biliary stent placement in an in vivo porcine model","msid":"","msnumber":"","nonDraftVersions":[{"code":2,"date":"2026-01-08 19:49:58","doi":"10.21203/rs.3.rs-6983888/v2","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}},{"code":1,"date":"2025-06-27 09:38:31","doi":"10.21203/rs.3.rs-6983888/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"c3062b4e-de4e-4276-ad2c-b4867e18a47f","owner":[],"postedDate":"January 8th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":50685803,"name":"Robotics"},{"id":50685804,"name":"Animal Science"},{"id":50685805,"name":"Gastroenterology \u0026 Hepatology"}],"tags":[],"updatedAt":"2025-06-27T09:38:31+00:00","versionOfRecord":[],"versionCreatedAt":"2026-01-08 19:49:58","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v2","identity":"rs-6983888","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6983888","identity":"rs-6983888","version":["v2"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}