Orthodontic rubber band combined with magnetic ring as a traction device for improving endoscopic submucosal dissection training

Orthodontic rubber band combined with magnetic ring as a traction device for improving endoscopic submucosal dissection training | 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 Orthodontic rubber band combined with magnetic ring as a traction device for improving endoscopic submucosal dissection training Linfu Zheng, Longping Chen, Fuqiang Wang, Zhilin Liu, Xingjie Gao, and 6 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5772300/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 10 Jul, 2025 Read the published version in BMC Medical Education → Version 1 posted 8 You are reading this latest preprint version Abstract Background Good exposure of the submucosal visual field is a prerequisite for successful endoscopic submucosal dissection (ESD). There are few reports on ESD training using orthodontic rubber band combined with magnetic ring traction (ORB-MA). This study evaluated the efficacy of ORB-MA traction for ESD training. Methods This study utilized an ex vivo porcine gastric model. Doctors experienced in endoscopic mucosal resection (> 100 cases), but not in ESD, were randomly divided into conventional and ORB-MR-assisted ESD groups. The practicality of ORB-MR traction was evaluated and procedure outcomes were compared between the two groups. The cumulative sum (CUSUM) method was used to construct the learning curves of ORB-MR and traditional ESD trainees respectively. Results A questionnaire survey of the ORB-MR-ESD group showed good satisfaction with ORB-MR. Per-Protocol analysis showed that the resection speed was faster in the ORB-MR group compared to the ESD group (11.61 ± 3.79 mm 2 /min vs. 6.66 ± 2.29 mm 2 /min, p < 0.001). Additionally, the former group exhibited a shorter operative time, lower submucosal injection volume, better visual field satisfaction, and a lower muscle injury rate. The learning curve of the ORB-MR physician reached the learning inflection point in case 9, while the learning inflection point of the traditional ESD physician appeared later, at case 13. Conclusions ORB-MR traction proved feasible and practical for ESD. It shortened the learning curve for ESD trainees and exhibited potential as a valuable method for ESD training. Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Figure 6 Introduction Magnetic anchor-guided endoscopic submucosal dissection (MA-ESD) utilizes magnetic fields to provide traction during the ESD procedure. Its main advantage over other traction methods is the lack of interference with endoscope action. The continuous movement of the external magnet provides dynamic traction by altering the direction of the pull [ 1 – 4 ] . In recent years, there have been significant advancements in magnetic anchor traction technology [ 5 ] , including MA-ESD [ 6 ] and magnetic bead tractor-ESD [ 7 ] , establishing its effectiveness and safety. However, the most significant limitation of MA-ESD is the exponential decay of magnetic force with distance, requiring the determination of the number of magnetic beads based on ESD difficulty and the presence of fibrosis in the lesion. We previously reported that the oral orthodontic rubber band (ORB) traction method could enhance the efficacy of gastric [ 8 ] and colorectal [ 9 ] ESD procedures. It also narrowed the proficiency gap between trainees and experts, demonstrating potential for ESD training [ 9 ] . In clinical practice, removing the clips fixed in normal mucosa after ESD can lead to mechanical mucosal damage, but not delayed bleeding or perforation. Patenotte et al. reported a case of massive postoperative hemorrhage caused by the removal of a contralateral intestinal wall clip following ORB traction [ 10 ] . Therefore, the present study combined ORB with small magnetic rings (MRs) to improve traction and evaluated the practicality and training benefits of ORB-MR for ESD trainees. This study was conducted in accordance with the tenets of the Declaration of Helsinki and approved by the Ethics Committee of the 900th Hospital of the PLA. Materials and methods ORB-MR device The ORB was attached to a small MR with outer and inner diameters of 8 mm and 5 mm, respectively, using a dental floss measuring 10–12 mm. The external magnetic device was a single-sided magnetic hanging ring with a diameter of 100 mm (Fig. 1 ). ORB-MR application for in vitro pig stomach ESD A self-made isolated porcine stomach model, consisting of a fresh porcine stomach (attached to the esophagus and pylorus) secured within a homemade container model, was used for ESD training (Fig. 2 ). The position of the in vitro pig stomach used in our study design for ESD was chosen at the greater curvature and anterior wall of the gastric antrum and the greater curvature and anterior wall of the lower body of the stomach. These four positions are relatively easy to operate on an in vitro pig stomach. Perform 4 ESD operations for each pig stomach to replace the new pig stomach. Doctors having an experience of more than 1000 gastroscopy and more than 100 endoscopic mucosal resection (EMR) cases, but no ESD experience (trainees), were divided into conventional ESD (C-ESD) and ORB-MR-ESD groups. Both groups performed ESD under guidance from experts (the number of upper gastrointestinal ESD cases is greater than 100) [ 11 ] . And each trainee will perform one C-ESD and one ORB-MR-ESD procedure. Draw lots to decide who will do the C-ESD or ORB-MR-ESD first. C-ESD involved marking, submucosal injection, peripheral mucosal incision, and complete dissection. In the ORB-MR-ESD procedure, after marking the intended ESD location, a peripheral mucosal incision was made. The ORB-MR device was inserted into the gastric cavity using a clip, with a magnetic hanging ring placed outside the stomach cavity. Magnetic attraction between the small MR and the external magnetic device facilitated lesion traction. In case of inadequate traction during dissection, the position of the magnetic hanging ring was adjusted to generate traction forces in different directions, allowing completion of the ESD procedure (Fig. 3 ). At the end of the ESD procedure, the ORB-MR device was removed with the specimen using a snare. Outcomes The primary outcome was resection speed, while the secondary outcomes included operation time, submucosal injection volume, visual field clarity, muscle injury rate, en-bloc resection rate, incidence of perforations, ESD completion rate, and operator satisfaction survey regarding the device. The operative time was submucosal injection to complete resection of the lesion. Visual field clarity was assessed on a scale ranging from 1 to 5 points, with 1 indicating the worst clarity and 5 indicating the best clarity. Muscle injury was defined as electrotome damage to the muscle layer during ESD submucosal dissection. En-bloc resection was complete resection of labelled lesions. ESD completion rate referred to both groups of trainees independently completing the ESD procedure without senior physician intervention. The questionnaire survey administered to operating trainees is shown in Fig. 4 (supplementary file). Learning curve In the self-made isolated porcine stomach model, 20 ESD procedures were performed by two trainees using the ORB-MR method and the C-ESD method, respectively. Four ESD operations were performed on each porcine stomach model. The size of each specimen was 20–30 mm, and the time of each ESD operation was recorded. The cumulative summation (CUSUM) value of the first case was the difference between the operation time of the first case and the average operation time of all cases, and then all CUSUMs were calculated. With the number of surgical cases as the horizontal coordinate and the CUSUM value as the vertical coordinate, EXCEL was used to draw the scatterplot of the learning curve. The learning curve of the two groups was calculated and the inflection point of the learning time was compared. Sample size calculation The pre-experimental findings indicated that the resection speed in the ORB-MR group was 12.87 ± 6.99 mm 2 /min, while that in the C-ESD group was 5.66 ± 5.03 mm 2 /min. PASS software was used to estimate that each group required 21 samples based on a statistical power of 90%, a significance level of 5%, a grouping ratio of 1:1, and an expected dropout rate of 20%. Therefore, the sample size for each group was taken as 27, resulting in a total sample size of 54. Statistical analysis Continuous variables were presented as means ± SD, while non-normally distributed data were expressed as medians and quartiles. Categorical variables were expressed as percentages. Measurement data were analyzed using t-test or non-parametric tests, while count data were analyzed using Chi-square test or Fisher’s exact probability method. Statistical analyses were performed using SPSS Statistics 25.0 software (IBM Corp., Armonk, NY, USA). A p -value < 0.05 indicated a statistically significant difference. SPSS25 software was used to perform the curve estimation fitting test for the CUSUM learning curve, and P < 0.05 indicated successful curve fitting. The R-squared coefficient was used to assess the goodness of fit. The larger the R-squared, the closer it was to 1, indicating that the model was the best fit. The CUSUM curve was used as the limit point in EXCEL. Results The 54 lesions were surgically treated by 27 trainees. The mean implantation time for ORB-MR was 1.95 ± 0.48 min. Compared to C-ESD, ORB-MR traction provided effective submucosal exposure under the gravitational influence of the disk. Due to magnetic attraction, there were no instances of ORB-MR device detachment from the lesion. All ORB-MR devices were successfully retrieved after surgery. Treatment outcomes The Intention-To-Treat (ITT) analysis revealed no significant difference in the target specimen size between the two groups ( p = 0.631). The independent completion rate of ESD was 100% in the ORB-MR group and 88.9% in the C-ESD group ( p = 0.236). The resection speed in the ORB-MR group was significantly faster than in the C-ESD group (11.61 mm 2 /min and 6.55 mm 2 /min, respectively, p < 0.001). Furthermore, the ORB-MR group demonstrated shorter operation times ( p < 0.001), lower submucosal injection volumes ( p < 0.001), higher visual field satisfaction ( p < 0.001), and a lower muscle injury rate ( p = 0.012). Although the ORB-MR group exhibited a higher en-bloc resection rate (96.3% vs. 77.8%) and a lower perforation rate (3.7% vs. 11.1%) compared to C-ESD, these differences were not statistically significant ( p > 0.05) (Table 1 ). Due to the failure of independent ESD completion in three C-ESD cases, only 23 cases were included in the C-ESD group. The Per-Protocol (PP)analysis (Table 2 ) demonstrated that the resection speeds in the ORB-MR and C-ESD groups were 11.61 ± 3.79 mm 2 /min and 6.66 ± 2.29 mm 2 /min, respectively ( p < 0.001). The ORB-MR group exhibited shorter operative times (33.37 ± 6.38 min) compared to the C-ESD group (51.08 ± 9.20 min) ( p < 0.001). The submucosal injection volume was also significantly lower in the ORB-MR group than in the C-ESD group (20.93 ± 5.53 mL vs. 39.50 ± 11.44 mL, p < 0.001). Moreover, the ORB-MR group reported higher visual field satisfaction ( p < 0.001) and a lower muscle injury rate (22.2% vs. 58.3%, p = 0.011). Although the ORB-MR group exhibited a higher en-bloc resection rate and a lower perforation incidence compared to the C-ESD group, these differences were not statistically significant ( p > 0.05). Results of physician questionnaire survey In the questionnaire survey, all ORB-MR-ESD group operating trainees reported that the traction device was simple, the operation was uncomplicated, and overall satisfaction with the traction method was high (Fig. 5 ). Comparison of learning curve between ORB-MR-ESD and C-ESD trainees Both ORB-MR-ESD and traditional ESD trainees completed 20 ESD procedures, and there was no statistical significance in the size of the lesions performed ( P > 0.05). The P-values of the quadratic and cubic curve fitting models in the ORB-MR-ESD physician were all less than 0.05, and the R-squared goodness of fit coefficients were 0.962 and 0.970, respectively. The third power of the goodness of fit is the optimal goodness of fit curve. The apex of the smooth curve is the lowest number of operations: 9 cases. In the C-ESD physician, the quadratic curve and cubic curve fitting model test P values were less than 0.05, the goodness of fit coefficient R-squared were 0.698 and 0.886, respectively. The cubic power of the fitting sum was the optimal fitting sum curve, and the vertex of the smooth curve was the lowest number of operations: 13 cases. (Fig. 6 ) Discussion The present study combined a highly elastic ORB with a small MR for improved traction. The results showed that the mean time for ORB-MR placement was 1.95 ± 0.48 min. The results of the questionnaire survey indicated that the modified ORB-MR traction method was simple and provided effective traction and can shorten ESD learning curve. Additionally, the ORB-MR traction method reduced the need for clip placement and all ORB-MR devices were successfully retrieved following ESD, potentially reducing the risk of mechanical injuries caused by clip removal. Despite significant advancements in digestive endoscopy over the past centuries, both human and equipment resources remain generally insufficient. Furthermore, there are extreme regional disparities in resource distribution, resulting in varying levels of technical expertise across countries, regions, and hospitals. It has been reported that China accounts for 50% of the global esophageal and gastric cancer burdens [ 12 ] , and that digestive tract tumors account for five of the top ten causes of cancer-related deaths [ 13 ] , with a trend towards younger age of onset [ 14 ] . Given the high incidence of gastrointestinal tumors, the current cohort of endoscopists falls short of meeting the population’s medical needs. While ESD is a recommended treatment for early gastrointestinal tumors [ 15 ] , it is a complex operation with a long learning curve [ 16 – 18 ] . Therefore, optimizing the training for ESD practitioners is of great clinical significance. Large animals, with gastrointestinal tract sizes similar to humans, are often used in endoscopic ultrasound [ 19 ] , Endoscopic retrograde cholangiopancreatography (ERCP) [ 20 ] , and ESD [ 21 ] training to simulate human digestive tract dynamics. In particular, live pigs are preferred for digestive endoscopy training [ 22 ] . Kuttner-Magalhaes et al. [ 23 ] demonstrated that using live pigs as ESD training models can improve en-bloc resection and R0 removal rates among trainees. However, live animals are costly and their use requires adherence to strict regulatory and ethical guidelines. Therefore, we used an in vitro pig belly model as an alternative to evaluate the efficacy of ORB-MR traction in shortening the training duration. Our study demonstrated that all trainees in the ORB-MR group successfully completed the surgery, whereas three trainees in the C-ESD group were unable to do so. PP analysis revealed that despite the lack of statistically significant differences in en-bloc resection rate and perforation incidence between the two groups, the resection speed in the ORB-MR group (11.61 ± 3.79 mm 2 /min) was significantly faster than that in the C-ESD group (6.66 ± 2.29 mm 2 /min). Furthermore, compared to the C-ESD group, the ORB-MR group exhibited higher satisfaction with visual field exposure, reduced submucosal injection volume, and shorter operation times. ORB-MR physician's learning inflection point occurs earlier than C-ESD physician. The results from a post-procedure questionnaire administered to the trainees demonstrated that the ORB-MR traction method was an effective tool for future training and learning. Our findings revealed muscle injury rates of 22.2% and 58.3% in the ORB-MR and C-ESD groups, respectively, with the former demonstrating a significantly lower rate ( p = 0.011). However, the rate was still higher than that reported by Yang et al. [ 24 ] for robot-assisted ESD operation performed by endoscopy trainees (2.5–10%). This may be because the trainees in the Yang et al. study all had 3 years of endoscopy experience, having performed over 1000 endoscopy procedures, and had over five times the in vitro ESD experience. In contrast, our study included trainees with an experience of over 100 colorectal EMR cases but no ESD experience. Matsuzaki et al. [ 3 ] reported that magnetic traction-assisted ESD can improve operational efficiency and satisfaction. They utilized two magnetic loops combined with a clip that attracted each other inside the intestinal cavity to create traction, resulting in a more complex setup, with one clip and one MR more than our method. Moreover, if the position of the MR and the clip was not securely fixed, it could compromise subsequent traction between the MRs. In contrast, our external magnetic device effectively attracted the small MR inside the stomach cavity, allowing for readjustment if needed to ensure effective traction. However, the ORB-MR device also has some limitations. Firstly, it requires an additional assistant to hold the external magnetic device. Secondly, the device cannot be inserted into the gastrointestinal cavity via the endoscopic working channel, limiting its applicability, particularly for the lesions in the right half of the colon. Finally, the in vitro animal stomach model used in our study could not simulate peristalsis, was influenced by respiratory movement, and lacked blood supply, limiting its ability to simulate bleeding complications encountered during ESD in the real-world situation. The use of ORB-MR to support ESD in live animal studies may be further explored. In conclusion, ORB combined with MR traction was found to be a feasible and practical method for ESD. It reduced technical difficulties for the trainees and showed potential as a valuable ESD training tool in the future. Declarations Disclosures : The authors declare no conflicts of interest. Fund : This project was supported by the Fujian Science and Technology Guiding Fund Project [Grant No. 2024Y0049] and [Grant No. 2023Y0070], Joint funding project for science and technology innovation [2024Y9664]. Data Availability The datasets used and analyzed during the current study are available from the corresponding author on reasonable request. Ethics declaration This study was conducted in accordance with the tenets of the Declaration of Helsinki and approved by the Ethics Committee of the 900th Hospital of the PLA. All participating trainees signed informed consent forms agreeing to anonymisation of their surgical data. Author Contribution L Z, L C, F W wrote the main manuscript text. L Z, L C, F W, Z L, X G, L Z, K L, Z W, B L, D L and W W acquired the data. 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Supplementary Files Questionnaire.docx Table1.docx Table2.docx Cite Share Download PDF Status: Published Journal Publication published 10 Jul, 2025 Read the published version in BMC Medical Education → Version 1 posted Editorial decision: Revision requested 10 Apr, 2025 Reviews received at journal 04 Apr, 2025 Reviews received at journal 01 Apr, 2025 Reviewers agreed at journal 01 Apr, 2025 Reviewers agreed at journal 30 Mar, 2025 Reviewers invited by journal 28 Mar, 2025 Submission checks completed at journal 25 Mar, 2025 First submitted to journal 20 Mar, 2025 You are reading this latest preprint version 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. 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Wang","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAAzUlEQVRIiWNgGAWjYBADfsb2xsaHH0jRItnYc7jZWIIkLQ0S6W0CPMQoNTh+9vBrnoo7EswzH7YxSDDYyek2ENJyJi/NmufMMwnG2YltDwoYko3NDhDQYnYgx8w4t+1wHVBLu4EEw4HEbQS1nH8D1PLvsATjzINtEjxEabmRY/w4twGoZQYjkVrsb7wxY/5zDKilJxEYyAZE+EWyP8f444yawxKG7ccfPvxQYSdHUAsQsIEj0LABRBoQVg4CzOBkIk+c4lEwCkbBKBiJAABvzEZ/jJzdTgAAAABJRU5ErkJggg==","orcid":"","institution":"Fuzhou General Clinical Medical College of Fujian Medical University","correspondingAuthor":true,"prefix":"","firstName":"Wen","middleName":"","lastName":"Wang","suffix":""}],"badges":[],"createdAt":"2025-01-06 09:08:07","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5772300/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5772300/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1186/s12909-025-07491-2","type":"published","date":"2025-07-10T15:57:02+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":79751761,"identity":"b5f86156-3d47-4be7-be97-fdd74d9528f4","added_by":"auto","created_at":"2025-04-02 09:27:10","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":347334,"visible":true,"origin":"","legend":"\u003cp\u003eOrthodontic rubber band combined with magnetic ring (ORB-MR) device.\u003c/p\u003e","description":"","filename":"Fig1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-5772300/v1/d987242f0c79403c5f0ffa81.jpg"},{"id":79747859,"identity":"41e8be61-afa4-46fa-b9ce-3891b7ef523a","added_by":"auto","created_at":"2025-04-02 09:03:10","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":4525272,"visible":true,"origin":"","legend":"\u003cp\u003eHomemade container model.\u003c/p\u003e","description":"","filename":"Fig2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-5772300/v1/4b131b227ebee5eccbf8705e.jpg"},{"id":79747856,"identity":"992adc4f-a700-497b-9c67-5634514832c4","added_by":"auto","created_at":"2025-04-02 09:03:10","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":184016,"visible":true,"origin":"","legend":"\u003cp\u003eORB-MR-ESD Procedure.\u003c/p\u003e\n\u003cp\u003eA: Cut the marked circumferential mucosa of the target range; B: The ORB-MA device was fixed on the incised mucosa; C: Traction using external magnetic rings; D: The submucosa can be exposed well by traction of ORB-MA after deep dissection; E: Move the external magnetic magnetic ring to form dynamic traction to ensure better pulling force; F: Complete resection of the target lesion.\u003c/p\u003e","description":"","filename":"Fig3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-5772300/v1/8a6c8fdd8186551fe605aa3d.jpg"},{"id":79749645,"identity":"ba2a0076-51f4-42dc-a13d-cb5266877807","added_by":"auto","created_at":"2025-04-02 09:11:10","extension":"jpg","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":71932,"visible":true,"origin":"","legend":"\u003cp\u003eThe questionnaire survey administered to operating trainees.\u003c/p\u003e","description":"","filename":"Fig4.jpg","url":"https://assets-eu.researchsquare.com/files/rs-5772300/v1/6fde8f954684158f5338db2a.jpg"},{"id":79747861,"identity":"63a91ab6-bb8b-47d6-b74b-8ce6f6cb6a4d","added_by":"auto","created_at":"2025-04-02 09:03:10","extension":"jpg","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":73009,"visible":true,"origin":"","legend":"\u003cp\u003eResults of physician questionnaire survey.\u003c/p\u003e","description":"","filename":"Fig5.jpg","url":"https://assets-eu.researchsquare.com/files/rs-5772300/v1/9eeea7e5f4b9d1907494301e.jpg"},{"id":79750389,"identity":"5e6ef1dc-866b-4540-93c3-f668091067b6","added_by":"auto","created_at":"2025-04-02 09:19:10","extension":"png","order_by":6,"title":"Figure 6","display":"","copyAsset":false,"role":"figure","size":96852,"visible":true,"origin":"","legend":"\u003cp\u003eLearning curve of ORB-MR-ESD physician and C-ESD physician.\u003c/p\u003e\n\u003cp\u003eA: Learning curve of ORB-MR physician; B: Learning curve of C-ESD physician.\u003c/p\u003e","description":"","filename":"6.png","url":"https://assets-eu.researchsquare.com/files/rs-5772300/v1/35c0643e84b7e0b16d425ffd.png"},{"id":86699253,"identity":"10caa14e-f475-448b-ab41-15cf00126bf6","added_by":"auto","created_at":"2025-07-14 16:05:45","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":5851942,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5772300/v1/a2d2df76-ac7b-41f4-be00-5a99afa08600.pdf"},{"id":79747851,"identity":"60505ac1-eac8-486a-9ff9-7f3786dcc96c","added_by":"auto","created_at":"2025-04-02 09:03:10","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":22262,"visible":true,"origin":"","legend":"","description":"","filename":"Questionnaire.docx","url":"https://assets-eu.researchsquare.com/files/rs-5772300/v1/e610d23f7635324f7a986c2e.docx"},{"id":79749644,"identity":"3917f8f3-e49c-47db-984d-4b6073295264","added_by":"auto","created_at":"2025-04-02 09:11:10","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":12493,"visible":true,"origin":"","legend":"","description":"","filename":"Table1.docx","url":"https://assets-eu.researchsquare.com/files/rs-5772300/v1/2c8feb65777d5bf6186106b0.docx"},{"id":79749639,"identity":"adf3fde0-e28c-45c8-af7d-83d578eca8f7","added_by":"auto","created_at":"2025-04-02 09:11:10","extension":"docx","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":12191,"visible":true,"origin":"","legend":"","description":"","filename":"Table2.docx","url":"https://assets-eu.researchsquare.com/files/rs-5772300/v1/fcbe3db9b2c5816823ef43c0.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Orthodontic rubber band combined with magnetic ring as a traction device for improving endoscopic submucosal dissection training","fulltext":[{"header":"Introduction","content":"\u003cp\u003eMagnetic anchor-guided endoscopic submucosal dissection (MA-ESD) utilizes magnetic fields to provide traction during the ESD procedure. Its main advantage over other traction methods is the lack of interference with endoscope action. The continuous movement of the external magnet provides dynamic traction by altering the direction of the pull\u003csup\u003e[\u003cspan additionalcitationids=\"CR2 CR3\" citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003e. In recent years, there have been significant advancements in magnetic anchor traction technology\u003csup\u003e[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/sup\u003e, including MA-ESD\u003csup\u003e[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]\u003c/sup\u003e and magnetic bead tractor-ESD\u003csup\u003e[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u003c/sup\u003e, establishing its effectiveness and safety. However, the most significant limitation of MA-ESD is the exponential decay of magnetic force with distance, requiring the determination of the number of magnetic beads based on ESD difficulty and the presence of fibrosis in the lesion.\u003c/p\u003e \u003cp\u003eWe previously reported that the oral orthodontic rubber band (ORB) traction method could enhance the efficacy of gastric\u003csup\u003e[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]\u003c/sup\u003e and colorectal\u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/sup\u003e ESD procedures. It also narrowed the proficiency gap between trainees and experts, demonstrating potential for ESD training\u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/sup\u003e. In clinical practice, removing the clips fixed in normal mucosa after ESD can lead to mechanical mucosal damage, but not delayed bleeding or perforation. Patenotte et al. reported a case of massive postoperative hemorrhage caused by the removal of a contralateral intestinal wall clip following ORB traction\u003csup\u003e[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]\u003c/sup\u003e. Therefore, the present study combined ORB with small magnetic rings (MRs) to improve traction and evaluated the practicality and training benefits of ORB-MR for ESD trainees. This study was conducted in accordance with the tenets of the Declaration of Helsinki and approved by the Ethics Committee of the 900th Hospital of the PLA.\u003c/p\u003e"},{"header":"Materials and methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eORB-MR device\u003c/h2\u003e \u003cp\u003eThe ORB was attached to a small MR with outer and inner diameters of 8 mm and 5 mm, respectively, using a dental floss measuring 10\u0026ndash;12 mm. The external magnetic device was a single-sided magnetic hanging ring with a diameter of 100 mm (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\u003cp\u003e \u003cb\u003eORB-MR application for\u003c/b\u003e \u003cb\u003ein vitro\u003c/b\u003e \u003cb\u003epig stomach ESD\u003c/b\u003e\u003c/p\u003e \u003cp\u003eA self-made isolated porcine stomach model, consisting of a fresh porcine stomach (attached to the esophagus and pylorus) secured within a homemade container model, was used for ESD training (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e). The position of the in vitro pig stomach used in our study design for ESD was chosen at the greater curvature and anterior wall of the gastric antrum and the greater curvature and anterior wall of the lower body of the stomach. These four positions are relatively easy to operate on an in vitro pig stomach. Perform 4 ESD operations for each pig stomach to replace the new pig stomach. Doctors having an experience of more than 1000 gastroscopy and more than 100 endoscopic mucosal resection (EMR) cases, but no ESD experience (trainees), were divided into conventional ESD (C-ESD) and ORB-MR-ESD groups. Both groups performed ESD under guidance from experts (the number of upper gastrointestinal ESD cases is greater than 100)\u003csup\u003e[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]\u003c/sup\u003e. And each trainee will perform one C-ESD and one ORB-MR-ESD procedure. Draw lots to decide who will do the C-ESD or ORB-MR-ESD first. C-ESD involved marking, submucosal injection, peripheral mucosal incision, and complete dissection.\u003c/p\u003e \u003cp\u003eIn the ORB-MR-ESD procedure, after marking the intended ESD location, a peripheral mucosal incision was made. The ORB-MR device was inserted into the gastric cavity using a clip, with a magnetic hanging ring placed outside the stomach cavity. Magnetic attraction between the small MR and the external magnetic device facilitated lesion traction. In case of inadequate traction during dissection, the position of the magnetic hanging ring was adjusted to generate traction forces in different directions, allowing completion of the ESD procedure (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e). At the end of the ESD procedure, the ORB-MR device was removed with the specimen using a snare.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eOutcomes\u003c/h3\u003e\n\u003cp\u003eThe primary outcome was resection speed, while the secondary outcomes included operation time, submucosal injection volume, visual field clarity, muscle injury rate, en-bloc resection rate, incidence of perforations, ESD completion rate, and operator satisfaction survey regarding the device. The operative time was submucosal injection to complete resection of the lesion. Visual field clarity was assessed on a scale ranging from 1 to 5 points, with 1 indicating the worst clarity and 5 indicating the best clarity. Muscle injury was defined as electrotome damage to the muscle layer during ESD submucosal dissection. En-bloc resection was complete resection of labelled lesions. ESD completion rate referred to both groups of trainees independently completing the ESD procedure without senior physician intervention. The questionnaire survey administered to operating trainees is shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e4\u003c/span\u003e (supplementary file).\u003c/p\u003e \n\u003ch3\u003eLearning curve\u003c/h3\u003e\n\u003cp\u003eIn the self-made isolated porcine stomach model, 20 ESD procedures were performed by two trainees using the ORB-MR method and the C-ESD method, respectively. Four ESD operations were performed on each porcine stomach model. The size of each specimen was 20\u0026ndash;30 mm, and the time of each ESD operation was recorded. The cumulative summation (CUSUM) value of the first case was the difference between the operation time of the first case and the average operation time of all cases, and then all CUSUMs were calculated. With the number of surgical cases as the horizontal coordinate and the CUSUM value as the vertical coordinate, EXCEL was used to draw the scatterplot of the learning curve. The learning curve of the two groups was calculated and the inflection point of the learning time was compared.\u003c/p\u003e\n\u003ch3\u003eSample size calculation\u003c/h3\u003e\n\u003cp\u003eThe pre-experimental findings indicated that the resection speed in the ORB-MR group was 12.87\u0026thinsp;\u0026plusmn;\u0026thinsp;6.99 mm\u003csup\u003e2\u003c/sup\u003e/min, while that in the C-ESD group was 5.66\u0026thinsp;\u0026plusmn;\u0026thinsp;5.03 mm\u003csup\u003e2\u003c/sup\u003e/min. PASS software was used to estimate that each group required 21 samples based on a statistical power of 90%, a significance level of 5%, a grouping ratio of 1:1, and an expected dropout rate of 20%. Therefore, the sample size for each group was taken as 27, resulting in a total sample size of 54.\u003c/p\u003e \u003cdiv id=\"Sec7\" class=\"Section2\"\u003e \u003ch2\u003eStatistical analysis\u003c/h2\u003e \u003cp\u003eContinuous variables were presented as means\u0026thinsp;\u0026plusmn;\u0026thinsp;SD, while non-normally distributed data were expressed as medians and quartiles. Categorical variables were expressed as percentages. Measurement data were analyzed using t-test or non-parametric tests, while count data were analyzed using Chi-square test or Fisher\u0026rsquo;s exact probability method. Statistical analyses were performed using SPSS Statistics 25.0 software (IBM Corp., Armonk, NY, USA). A \u003cem\u003ep\u003c/em\u003e-value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 indicated a statistically significant difference. SPSS25 software was used to perform the curve estimation fitting test for the CUSUM learning curve, and \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 indicated successful curve fitting. The R-squared coefficient was used to assess the goodness of fit. The larger the R-squared, the closer it was to 1, indicating that the model was the best fit. The CUSUM curve was used as the limit point in EXCEL.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003eThe 54 lesions were surgically treated by 27 trainees. The mean implantation time for ORB-MR was 1.95\u0026thinsp;\u0026plusmn;\u0026thinsp;0.48 min. Compared to C-ESD, ORB-MR traction provided effective submucosal exposure under the gravitational influence of the disk. Due to magnetic attraction, there were no instances of ORB-MR device detachment from the lesion. All ORB-MR devices were successfully retrieved after surgery.\u003c/p\u003e\n\u003ch3\u003eTreatment outcomes\u003c/h3\u003e\n\u003cp\u003eThe Intention-To-Treat (ITT) analysis revealed no significant difference in the target specimen size between the two groups (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.631). The independent completion rate of ESD was 100% in the ORB-MR group and 88.9% in the C-ESD group (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.236). The resection speed in the ORB-MR group was significantly faster than in the C-ESD group (11.61 mm\u003csup\u003e2\u003c/sup\u003e/min and 6.55 mm\u003csup\u003e2\u003c/sup\u003e/min, respectively, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Furthermore, the ORB-MR group demonstrated shorter operation times (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001), lower submucosal injection volumes (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001), higher visual field satisfaction (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001), and a lower muscle injury rate (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.012). Although the ORB-MR group exhibited a higher en-bloc resection rate (96.3% vs. 77.8%) and a lower perforation rate (3.7% vs. 11.1%) compared to C-ESD, these differences were not statistically significant (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05) (Table \u003cspan class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eDue to the failure of independent ESD completion in three C-ESD cases, only 23 cases were included in the C-ESD group. The Per-Protocol (PP)analysis (Table \u003cspan class=\"InternalRef\"\u003e2\u003c/span\u003e) demonstrated that the resection speeds in the ORB-MR and C-ESD groups were 11.61\u0026thinsp;\u0026plusmn;\u0026thinsp;3.79 mm\u003csup\u003e2\u003c/sup\u003e/min and 6.66\u0026thinsp;\u0026plusmn;\u0026thinsp;2.29 mm\u003csup\u003e2\u003c/sup\u003e/min, respectively (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001). The ORB-MR group exhibited shorter operative times (33.37\u0026thinsp;\u0026plusmn;\u0026thinsp;6.38 min) compared to the C-ESD group (51.08\u0026thinsp;\u0026plusmn;\u0026thinsp;9.20 min) (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001). The submucosal injection volume was also significantly lower in the ORB-MR group than in the C-ESD group (20.93\u0026thinsp;\u0026plusmn;\u0026thinsp;5.53 mL vs. 39.50\u0026thinsp;\u0026plusmn;\u0026thinsp;11.44 mL, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Moreover, the ORB-MR group reported higher visual field satisfaction (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001) and a lower muscle injury rate (22.2% vs. 58.3%, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.011). Although the ORB-MR group exhibited a higher en-bloc resection rate and a lower perforation incidence compared to the C-ESD group, these differences were not statistically significant (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05).\u003c/p\u003e\n\u003ch3\u003eResults of physician questionnaire survey\u003c/h3\u003e\n\u003cp\u003eIn the questionnaire survey, all ORB-MR-ESD group operating trainees reported that the traction device was simple, the operation was uncomplicated, and overall satisfaction with the traction method was high (Fig. \u003cspan class=\"InternalRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e\n\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\n \u003ch2\u003eComparison of learning curve between ORB-MR-ESD and C-ESD trainees\u003c/h2\u003e\n \u003cp\u003eBoth ORB-MR-ESD and traditional ESD trainees completed 20 ESD procedures, and there was no statistical significance in the size of the lesions performed (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026gt;\u0026thinsp;0.05). The P-values of the quadratic and cubic curve fitting models in the ORB-MR-ESD physician were all less than 0.05, and the R-squared goodness of fit coefficients were 0.962 and 0.970, respectively. The third power of the goodness of fit is the optimal goodness of fit curve. The apex of the smooth curve is the lowest number of operations: 9 cases. In the C-ESD physician, the quadratic curve and cubic curve fitting model test P values were less than 0.05, the goodness of fit coefficient R-squared were 0.698 and 0.886, respectively. The cubic power of the fitting sum was the optimal fitting sum curve, and the vertex of the smooth curve was the lowest number of operations: 13 cases. (Fig. \u003cspan class=\"InternalRef\"\u003e6\u003c/span\u003e)\u003c/p\u003e\n\u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThe present study combined a highly elastic ORB with a small MR for improved traction. The results showed that the mean time for ORB-MR placement was 1.95\u0026thinsp;\u0026plusmn;\u0026thinsp;0.48 min. The results of the questionnaire survey indicated that the modified ORB-MR traction method was simple and provided effective traction and can shorten ESD learning curve. Additionally, the ORB-MR traction method reduced the need for clip placement and all ORB-MR devices were successfully retrieved following ESD, potentially reducing the risk of mechanical injuries caused by clip removal.\u003c/p\u003e \u003cp\u003eDespite significant advancements in digestive endoscopy over the past centuries, both human and equipment resources remain generally insufficient. Furthermore, there are extreme regional disparities in resource distribution, resulting in varying levels of technical expertise across countries, regions, and hospitals. It has been reported that China accounts for 50% of the global esophageal and gastric cancer burdens\u003csup\u003e[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]\u003c/sup\u003e, and that digestive tract tumors account for five of the top ten causes of cancer-related deaths\u003csup\u003e[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/sup\u003e, with a trend towards younger age of onset\u003csup\u003e[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]\u003c/sup\u003e. Given the high incidence of gastrointestinal tumors, the current cohort of endoscopists falls short of meeting the population\u0026rsquo;s medical needs. While ESD is a recommended treatment for early gastrointestinal tumors\u003csup\u003e[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/sup\u003e, it is a complex operation with a long learning curve\u003csup\u003e[\u003cspan additionalcitationids=\"CR17\" citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/sup\u003e. Therefore, optimizing the training for ESD practitioners is of great clinical significance.\u003c/p\u003e \u003cp\u003eLarge animals, with gastrointestinal tract sizes similar to humans, are often used in endoscopic ultrasound\u003csup\u003e[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]\u003c/sup\u003e, Endoscopic retrograde cholangiopancreatography (ERCP)\u003csup\u003e[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e]\u003c/sup\u003e, and ESD\u003csup\u003e[\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e]\u003c/sup\u003e training to simulate human digestive tract dynamics. In particular, live pigs are preferred for digestive endoscopy training\u003csup\u003e[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]\u003c/sup\u003e. Kuttner-Magalhaes et al.\u003csup\u003e[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]\u003c/sup\u003e demonstrated that using live pigs as ESD training models can improve en-bloc resection and R0 removal rates among trainees. However, live animals are costly and their use requires adherence to strict regulatory and ethical guidelines. Therefore, we used an \u003cem\u003ein vitro\u003c/em\u003e pig belly model as an alternative to evaluate the efficacy of ORB-MR traction in shortening the training duration.\u003c/p\u003e \u003cp\u003eOur study demonstrated that all trainees in the ORB-MR group successfully completed the surgery, whereas three trainees in the C-ESD group were unable to do so. PP analysis revealed that despite the lack of statistically significant differences in en-bloc resection rate and perforation incidence between the two groups, the resection speed in the ORB-MR group (11.61\u0026thinsp;\u0026plusmn;\u0026thinsp;3.79 mm\u003csup\u003e2\u003c/sup\u003e/min) was significantly faster than that in the C-ESD group (6.66\u0026thinsp;\u0026plusmn;\u0026thinsp;2.29 mm\u003csup\u003e2\u003c/sup\u003e/min). Furthermore, compared to the C-ESD group, the ORB-MR group exhibited higher satisfaction with visual field exposure, reduced submucosal injection volume, and shorter operation times. ORB-MR physician's learning inflection point occurs earlier than C-ESD physician. The results from a post-procedure questionnaire administered to the trainees demonstrated that the ORB-MR traction method was an effective tool for future training and learning.\u003c/p\u003e \u003cp\u003eOur findings revealed muscle injury rates of 22.2% and 58.3% in the ORB-MR and C-ESD groups, respectively, with the former demonstrating a significantly lower rate (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;=\u0026thinsp;0.011). However, the rate was still higher than that reported by Yang et al.\u003csup\u003e[\u003cspan citationid=\"CR24\" class=\"CitationRef\"\u003e24\u003c/span\u003e]\u003c/sup\u003e for robot-assisted ESD operation performed by endoscopy trainees (2.5\u0026ndash;10%). This may be because the trainees in the Yang et al. study all had 3 years of endoscopy experience, having performed over 1000 endoscopy procedures, and had over five times the \u003cem\u003ein vitro\u003c/em\u003e ESD experience. In contrast, our study included trainees with an experience of over 100 colorectal EMR cases but no ESD experience.\u003c/p\u003e \u003cp\u003eMatsuzaki et al.\u003csup\u003e[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e reported that magnetic traction-assisted ESD can improve operational efficiency and satisfaction. They utilized two magnetic loops combined with a clip that attracted each other inside the intestinal cavity to create traction, resulting in a more complex setup, with one clip and one MR more than our method. Moreover, if the position of the MR and the clip was not securely fixed, it could compromise subsequent traction between the MRs. In contrast, our external magnetic device effectively attracted the small MR inside the stomach cavity, allowing for readjustment if needed to ensure effective traction.\u003c/p\u003e \u003cp\u003eHowever, the ORB-MR device also has some limitations. Firstly, it requires an additional assistant to hold the external magnetic device. Secondly, the device cannot be inserted into the gastrointestinal cavity via the endoscopic working channel, limiting its applicability, particularly for the lesions in the right half of the colon. Finally, the \u003cem\u003ein vitro\u003c/em\u003e animal stomach model used in our study could not simulate peristalsis, was influenced by respiratory movement, and lacked blood supply, limiting its ability to simulate bleeding complications encountered during ESD in the real-world situation. The use of ORB-MR to support ESD in live animal studies may be further explored.\u003c/p\u003e \u003cp\u003eIn conclusion, ORB combined with MR traction was found to be a feasible and practical method for ESD. It reduced technical difficulties for the trainees and showed potential as a valuable ESD training tool in the future.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eDisclosures\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe authors declare no conflicts of interest.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFund\u003c/strong\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThis project was supported by the Fujian Science and Technology Guiding Fund Project [Grant No. 2024Y0049] and [Grant No. 2023Y0070], Joint funding project for science and technology innovation [2024Y9664].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and analyzed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics declaration\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was conducted in accordance with the tenets of the Declaration of Helsinki and approved by the Ethics Committee of the 900th Hospital of the PLA. All participating trainees signed informed consent forms agreeing to anonymisation of their surgical data.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Contribution\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eL Z, L C, F W wrote the main manuscript text. L Z, L C, F W, Z L, X G, L Z, K L, Z W, B L, D L and W W acquired the data. D L and W W revised of the manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eMortagy M, Mehta N, Parsi MA, et al. Magnetic anchor guidance for endoscopic submucosal dissection and other endoscopic procedures. World J Gastroenterol. 2017;23(16):2883\u0026ndash;90.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eRam\u0026iacute;rez-Ram\u0026iacute;rez M\u0026Aacute;, Zamorano-Orozco Y, Beltr\u0026aacute;n-Campos EG. Simplified magnetic anchor-guided endoscopic submucosal dissection: an ex vivo porcine model. Rev Gastroenterol Mex (Engl Ed). 2022;87(1):13\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMatsuzaki I, Hattori M, Yamauchi H, et al. Magnetic anchor-guided endoscopic submucosal dissection for colorectal tumors (with video). Surg Endosc. 2020;34(2):1012\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePan M, Zhang MM, Xu SQ, Lyu Y, Yan XP. Magnetic anchor technique assisted endoscopic submucosal dissection for early esophageal cancer. World J Gastrointest Endosc. 2023;15(10):584\u0026ndash;92.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZhang X, Zhang J, Liang Y, et al. First pilot trial of colorectal ESD guided by a new magnetic anchor for ease of placement. Tech Coloproctol. 2023;27(8):679\u0026ndash;83.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMatsuzaki I, Hattori M, Hirose K, et al. Magnetic anchor-guided endoscopic submucosal dissection for gastric lesions (with video). Gastrointest Endosc. 2018;87(6):1576\u0026ndash;80.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYe L, Yuan X, Pang M, et al. Magnetic bead-assisted endoscopic submucosal dissection: a gravity-based traction method for treating large superficial colorectal tumors. Surg Endosc. 2019;33(6):2034\u0026ndash;41.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLi D, Zheng L, Zhang Z, et al. Usefulness of the combined orthodontic rubber band and clip method for gastric endoscopic submucosal dissection. BMC Gastroenterol. 2022;22(1):527.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZheng L, Wang W, Li D et al. Orthodontic Rubber Band-Assisted Endoscopic Submucosal Dissection: An Efficient Method for Treating Superficial Colorectal Tumors. Gastroenterol Res Pract. 2022. 2022: 2835258.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePatenotte A, Lupu A, Jacques J, Rivory J, Rostain F, Pioche M. Hemorrhage from the point of traction on the opposing wall after colonic endoscopic submucosal dissection using countertraction: a rare adverse event. Endoscopy. 2021;53(8):E279\u0026ndash;80.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMitsui T, Yoda Y, Sunakawa H, et al. Development of new gastric endoscopic submucosal dissection training model: A reproducibility evaluation study. Endosc Int Open. 2022;10(9):E1261\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eXia R, Zeng H, Liu W, et al. Estimated Cost-effectiveness of Endoscopic Screening for Upper Gastrointestinal Tract Cancer in High-Risk Areas in China. JAMA Netw Open. 2021;4(8):e2121403.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eCao R, Guo S, Min L, Li P. Roles of Rictor alterations in gastrointestinal tumors (Review). Oncol Rep. 2024;51(2):37. [pii].\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBen-Aharon I, van Laarhoven H, Fontana E, Obermannova R, Nilsson M, Lordick F. Early-Onset Cancer in the Gastrointestinal Tract Is on the Rise-Evidence and Implications. Cancer Discov. 2023;13(3):538\u0026ndash;51.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePimentel-Nunes P, Lib\u0026acirc;nio D, Bastiaansen B, et al. Endoscopic submucosal dissection for superficial gastrointestinal lesions: European Society of Gastrointestinal Endoscopy (ESGE) Guideline - Update 2022. Endoscopy. 2022;54(6):591\u0026ndash;622.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKamitani Y, Nonaka K, Misumi Y, Isomoto H. Safe and Efficient Procedures and Training System for Endoscopic Submucosal Dissection. J Clin Med. 2023;12(11):3692.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eSimsek C, Aihara H. Training in Endoscopic Submucosal Dissection in the United States: The Current Paradigm. Gastrointest Endosc Clin N Am. 2023;33(1):41\u0026ndash;53.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eLib\u0026acirc;nio D, Pimentel-Nunes P, Bastiaansen B, et al. Endoscopic submucosal dissection techniques and technology: European Society of Gastrointestinal Endoscopy (ESGE) Technical Review. Endoscopy. 2023;55(4):361\u0026ndash;89.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBarthet M, Gasmi M, Boustiere C, Giovannini M, Grimaud JC, Berdah S. EUS training in a live pig model: does it improve echo endoscope hands-on and trainee competence. Endoscopy. 2007;39(6):535\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNoar MD. An established porcine model for animate training in diagnostic and therapeutic ERCP. Endoscopy. 1995;27(1):77\u0026ndash;80.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBerr F, Ponchon T, Neureiter D, et al. Experimental endoscopic submucosal dissection training in a porcine model: learning experience of skilled Western endoscopists. Dig Endosc. 2011;23(4):281\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eFinocchiaro M, Cortegoso Valdivia P, Hernansanz A et al. Training Simulators for Gastrointestinal Endoscopy: Current and Future Perspectives. Cancers (Basel). 2021. 13(6): 1427.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eK\u0026uuml;ttner-Magalh\u0026atilde;es R, Dinis-Ribeiro M, Bruno MJ, Marcos-Pinto R, Rolanda C, Koch AD. A Steep Early Learning Curve for Endoscopic Submucosal Dissection in the Live Porcine Model. Dig Dis. 2022;40(6):816\u0026ndash;25.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eYang X, Fu S, Li L, et al. Robot-assisted endoscopic submucosal dissection contributes to efficient and safe learning for novices: Prospective pilot cross-over ex vivo study (with video). Dig Endosc. 2023;35(3):342\u0026ndash;51.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTables 1 and 2 are available in the Supplementary Files section.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-medical-education","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"meed","sideBox":"Learn more about [BMC Medical Education](http://bmcmededuc.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/meed/default.aspx","title":"BMC Medical Education","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-5772300/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5772300/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eGood exposure of the submucosal visual field is a prerequisite for successful endoscopic submucosal dissection (ESD). There are few reports on ESD training using orthodontic rubber band combined with magnetic ring traction (ORB-MA). This study evaluated the efficacy of ORB-MA traction for ESD training.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eThis study utilized an \u003cem\u003eex vivo\u003c/em\u003e porcine gastric model. Doctors experienced in endoscopic mucosal resection (\u0026gt;\u0026thinsp;100 cases), but not in ESD, were randomly divided into conventional and ORB-MR-assisted ESD groups. The practicality of ORB-MR traction was evaluated and procedure outcomes were compared between the two groups. The cumulative sum (CUSUM) method was used to construct the learning curves of ORB-MR and traditional ESD trainees respectively.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eA questionnaire survey of the ORB-MR-ESD group showed good satisfaction with ORB-MR. Per-Protocol analysis showed that the resection speed was faster in the ORB-MR group compared to the ESD group (11.61\u0026thinsp;\u0026plusmn;\u0026thinsp;3.79 mm\u003csup\u003e2\u003c/sup\u003e/min vs. 6.66\u0026thinsp;\u0026plusmn;\u0026thinsp;2.29 mm\u003csup\u003e2\u003c/sup\u003e/min, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.001). Additionally, the former group exhibited a shorter operative time, lower submucosal injection volume, better visual field satisfaction, and a lower muscle injury rate. The learning curve of the ORB-MR physician reached the learning inflection point in case 9, while the learning inflection point of the traditional ESD physician appeared later, at case 13.\u003c/p\u003e\u003ch2\u003eConclusions\u003c/h2\u003e \u003cp\u003eORB-MR traction proved feasible and practical for ESD. It shortened the learning curve for ESD trainees and exhibited potential as a valuable method for ESD training.\u003c/p\u003e","manuscriptTitle":"Orthodontic rubber band combined with magnetic ring as a traction device for improving endoscopic submucosal dissection training","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-04-02 09:03:05","doi":"10.21203/rs.3.rs-5772300/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Revision requested","date":"2025-04-10T05:02:16+00:00","index":"","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-05T02:48:51+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-04-01T17:40:00+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"91936515403474187587661936134097919202","date":"2025-04-01T16:42:48+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"207093072107637098108391767923518654893","date":"2025-03-30T23:09:55+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-03-28T20:06:49+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-03-25T14:08:14+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Medical Education","date":"2025-03-20T12:28:58+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-medical-education","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"meed","sideBox":"Learn more about [BMC Medical Education](http://bmcmededuc.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/meed/default.aspx","title":"BMC Medical Education","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"920897dc-ac78-45b5-aca1-779e685b0e99","owner":[],"postedDate":"April 2nd, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-07-14T15:59:03+00:00","versionOfRecord":{"articleIdentity":"rs-5772300","link":"https://doi.org/10.1186/s12909-025-07491-2","journal":{"identity":"bmc-medical-education","isVorOnly":false,"title":"BMC Medical Education"},"publishedOn":"2025-07-10 15:57:02","publishedOnDateReadable":"July 10th, 2025"},"versionCreatedAt":"2025-04-02 09:03:05","video":"","vorDoi":"10.1186/s12909-025-07491-2","vorDoiUrl":"https://doi.org/10.1186/s12909-025-07491-2","workflowStages":[]},"version":"v1","identity":"rs-5772300","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5772300","identity":"rs-5772300","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}