Stent fixation could reduce the stent migration rate: a comprehensive systematic review and meta-analysis

Stent fixation could reduce the stent migration rate: a comprehensive systematic review and meta-analysis | 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 Systematic Review Stent fixation could reduce the stent migration rate: a comprehensive systematic review and meta-analysis Abdelaziz A. Awad, Esraa Awad, Ahmed Bahnasy, Youssef Narouz, and 11 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7457023/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Background Endoscopic placement of self-expandable metal stents (SEMS) is a minimally invasive intervention, aiming to restore luminal patency in GIT obstruction patients. As stent migration is considered a major sequela, techniques for its fixation have been established. This study aims to assess the efficacy of stent fixation using either endoscopic suture fixation or over-the-scope clips (OTSC). Methods Following the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we searched available databases (PubMed, Scopus, and Web of Science) to identify eligible studies reported up to January 2025. Using RevMan 5.4, we reported outcomes as odds ratios (OR) and confidence intervals (CIs). A P-value ≤ 0.05 was considered statistically significant. Results Twelve studies were included in this meta-analysis, with a total of 1136 patients. The pooled OR for stent fixation is 0.32 (95% CI: 0.19–0.57; p < 0.001), with moderate heterogeneity (I² = 59%, P = 0.005). According to the subgroup analysis in relation to the fixation method, suture fixation yields a pooled OR of 0.37 (95% CI: 0.19–0.69; p = 0.002), and OTSC fixation yields a pooled OR of 0.25 (95% CI: 0.11–0.54; p = 0.0004). There is no statistically significant difference between these subgroups (p = 0.45, I² = 0%). There was no statistically significant difference in the rates of adverse events; with a pooled OR of 0.71 (95% CI: 0.33–1.54), and substantial heterogeneity (I 2 = 73%; P = 0.002). Conclusion Statistically significant lower stent migration rates were reported following either endoscopic suture fixation or OTSC, along with higher clinical success rates. Future clinical trials with longer follow-up durations are recommended to accurately update the guidelines. Stent migration stent fixation endoscopic suturing OTSC Figures Figure 1 Figure 2 Figure 3 Figure 4 1. Introduction Advanced malignancies and benign strictures can be complicated with gastrointestinal tract (GIT) obstruction, presenting with severe manifestations as dysphagia. Endoscopic placement of self-expandable metal stents (SEMS) is a well-established, minimally invasive intervention to restore luminal patency in these patients, and it is routinely used in a variety of malignant and benign GI conditions.( 1 ) However, a major drawback of SEMS—particularly fully covered stents chosen for benign indications—is the risk of stent migration. Stent migration is the most common stent-related complication, with reported incidence ranging from approximately 30–60% in patients with fully covered stents.( 2 ) A migrated stent can lead to therapy failure and often necessitates additional endoscopic procedures for repositioning or removal, imparting further morbidity and healthcare burden.( 3 ) In response to the high migration rates, various endoscopic fixation techniques have been developed to secure fully covered self-expanding metal stents (FCSEMS) in place. Among these, endoscopic suturing and over-the-scope clip (OTSC) placement are the most widely adopted techniques. Emerging evidence from retrospective studies indicates that such fixation can substantially reduce migration rates. In esophageal stenting, endoscopic suture fixation has been shown to significantly reduce the migration incidence to roughly 10–20%.( 4 , 5 ) Similarly, OTSC anchoring of FCSEMS has demonstrated markedly lower migration frequencies; one study reported an 8% migration rate with OTSC fixation versus 35% without fixation in esophageal stents.( 5 ) Both techniques have exhibited high technical success with minimal device-related adverse events, and some reports suggest that preventing stent migration through fixation may also improve overall clinical success of the therapy by maintaining stent patency until the underlying condition is resolved.( 4 , 5 ) Despite these advances, literature yields inconsistent results, and no clear consensus has been reached on the necessity or optimal method of stent fixation. Notably, one retrospective series found no significant difference in migration rates between fixed or free stents,( 3 ) suggesting that routine anchoring might not always confer benefit. Another comparative study reported that an OTSC fixation device achieved significantly lower migration rates than either suturing or no fixation, highlighting a potential advantage of clip fixation over sutures in certain settings.( 6 ) The heterogeneity of findings may be influenced by differences in study populations (e.g. esophageal vs. colonic stents, benign vs. malignant etiologies) and varying methodologies. Moreover, the existing evidence is based mainly on single-center retrospective studies without randomized trials, which limits definitive conclusions. These limitations and conflicting outcomes in literature underscore a gap in knowledge and a lack of consensus regarding whether stent fixation should be routinely performed and which fixation strategy is superior. This systematic review and meta-analysis aims to evaluate the outcomes of fixation versus no fixation for gastrointestinal stents, specifically analyzing stent migration, clinical success, and adverse events across different fixation techniques. 2. Methods 2.1 Information Sources and Search Strategy A systematic search was conducted across available databases: PubMed, Scopus, and Web of Science, aiming to include relevant published clinical trials from their inception to January 2025. We used a specific search strategy using specific keywords, employing the MeSH indexing tool. The full details of the used search strategy are reported in Table S1 . This was followed by title and abstract screening using Rayyan.( 7 ) Eligible studies entered full text screening. The screening process was conducted by two independent reviewers, with conflicts being resolved by the main author. The study relied on the Cochrane Handbook of Systematic Reviews and Meta-analysis,( 8 ) while following the PRISMA statement guidelines in writing the systematic review.( 9 ) 2.2 Eligibility Criteria Inclusion criteria Studies, regardless of the design, were deemed eligible according to the following criteria: Population: adults patients between the age of 18 and 80 years old, referred for stent placement for any GIT indication. Intervention (s): stent fixation using either the endoscopic suture fixation or OTSC. Comparator (s): no fixation. Outcomes: stent migration, clinical success, and adverse events rates. Exclusion criteria Non-English full-text, experimental animal studies, case reports, reviews, editorials, abstracts, conference presentations, unattainable full-text and overlapping data were excluded. 2.3 Data Extraction Data from the qualifying studies were extracted onto uniform data extraction sheets by two independent reviewers, followed by cross-checking and solving any disparities. The following data were extracted in separate sheets: characteristics of the included studies ( study ID, study design, location, sample size, age, gender, main condition, and fixation method), and the reported clinical outcomes (stent migration, clinical success, and adverse events rates). 2.4 Quality assessment The quality of the included randomized controlled trials (RCTs) was assessed by two independent reviewers, using the Cochrane Collaboration’s Risk of Bias Tool (version 2).( 10 ) These five domains have been investigated: the randomization process, deviations from the intended interventions, missing outcome data, outcome measurement, and selection of the reported results. Investigators categorize their judgments as “High risk”, “Low risk”, or “some concerns” of bias for each domain. A third investigator addressed and resolved any disagreements that arose. ROBINS 1 quality assessment tool was utilized for the included non-randomized controlled trials.( 11 ) It investigates the following domains: risk of bias due to confounding, bias in classification of interventions, bias in selection of participants into the study (or into the analysis), deviations from intended interventions, missing data, bias arising from measurement of the outcomes, and bias in selection of the reported results. The Newcastle Ottawa scale (NOS) was utilized to assess the quality of the included observational studies, across the following domains: potential bias arising from the study participants' selection, the groups' comparability, and the ascertainment of the outcome.( 12 ) 2.5 Statistical analysis Dichotomous data were pooled as odds ratio (OR) with a 95% confidence interval (CI). RevMan 5.4 for Windows was used for all statistical analyses and forest plot generation. ( 13 ) Fixed models were used if there was no statistically significant heterogeneity, and random models were used otherwise. We visually inspected the forest plots to evaluate potential statistical heterogeneity across the included studies. The Chi-square test, also referred to as the Cochrane Q test, along with Higgins and Thompson's I2 (calculated as I2 = ((Q-df)/Q) x 100%), was utilized to quantify this heterogeneity. A p-value below 0.1 from the chi-square test deemed it statistically significant. Levels were categorized as low, moderate, and high based on I2 values below 25%, 25–75%, and above 75%, respectively.( 14 ) We performed a sensitivity analysis (leave-one-out test) in an attempt to resolve any existing heterogeneity. 3. Results 3.1 Literature search Our literature search identified 3583 citations through the used domains. Title and abstract screening resulted in the exclusion of 3500 studies. Eighty-three studies were eligible for full-text screening. Subsequently, 71 records were excluded. Twelve studies met the eligibility criteria for this systematic review. Details of the search results are reported in the reported PRISMA flow diagram, shown in Fig. 1 . 3.2 Characteristics of the included studies Twelve studies are reported in our review, including three RCTs, one non-randomized clinical trials, one pilot trial, and seven retrospective cohort studies.( 15 – 26 ) The mean age of the included population ranged between 50 and 77.5 years. Table 1 shows the characteristics of the included studies. Table 1 Characteristics of the included studies: Study ID Study design Sample size Age, mean (SD) Sex, n (male %) Main disease Fixation method Intervention Control Intervention Control Intervention Control Siddiqui 2016 Retrospective cohort 26 67 69.9 ± 11.8 66.9 ± 11 17 (65) 51 (76) Esophageal cancer Endoscopic suture Sharaiha 2014 Retrospective cohort 17 20 55.7 ± 15.6 58.5 ± 17.2 18 (48.65) Esophageal strictures and leaks Endoscopic suture Mehta 2024 Retrospective cohort SF = 94, ES = 95 122 SF= 62 ± 14, ES = 56 ± 16 60 ± 16 SF = 47(50), ES= 47(49) 60(49) Nonmalignant strictures, fistulas, perforations, leaks, and variceal bleeding Endoscopic suture and Over-the-scope clips Ngamruengphong 2017 Retrospective cohort 46 28 54 ± 17 50 ± 15 21(46) 12(43) Upper gastrointestinal conditions, defined as strictures, fistulae, leaks and perforations Endoscopic suture DuBroff 2025 Retrospective cohort 27 28 - - 16 (49) 18 (64) Both benign and malignant upper esophageal conditions Clips with anchor prongs Schiemer 2022 Retrospective cohort 26 51 66.6 ± 16 66.3 ± 12.2 19 (73.1) 36 (70.6) Both benign and malignant upper esophageal conditions Over-the-scope clips Obaitan 2021 Retrospective cohort 23 91 56.25 ± 18.41 56.25 ± 13.59 18 (78.26) 58 (63.74) Post-operative leak, Tracheo-esophageal fistula, Endoscopic perforation, Food impaction, Esophago-pleural fistula, Malignant stricture, Boerhaave’s syndrome, Unknown cause Endoscopic suture Vanbiervliet 2011 Pilot comparative study 23 21 63.6 ± 17.7 67.3 ± 17.4 12 (52) 13 (62) Esophageal stricture, Fistulas and perforations Clips Rieder 2017 Clinical trial Endoscopic clip group = 5. Suture fixation gorup = 4 2 Clip = 67.4 ± 19.642, Suture = 57 ± 18.708 77.5 ± 2.121 Clip = 2 (40), Suture- 1 ( 25 ) 1 (50) Achalasia Clips and sutures Ngamruengphong 2016 Retrospective cohort 81 44 59 ± 16 54 ± 18 19(43) 48(59) Benign esophageal. Gastric and duedenal pathology Endoscopic suture Singh 2025 Randomized controlled trials 24 22 63.08 ± 10.44 68.17 ± 11.49 17 (70.8) 16 (72.7) Esophageal strictures Endoscopic suture Thiruvengadam 2021 Retrospective cohort 22 5 nonbariatric nonesophageal gastroenteric foregut leaks Suture Qualitative data are presented as mean (standard deviation). Quantitative data are presented as number (percentage). 3.3 Quality assessment results: Using NOS, the quality of the included cohorts was deemed good, with scores ranging between six and nine ( Table S2) . The trials included were of high quality, except one rasing some concerns due to confounding bias ( Figure S1 ). 3.3 Meta-analysis Stent Migration Twelve studies reported on stent migration rates with and without fixation. The pooled OR is 0.32 (95% CI: 0.19–0.57; p < 0.001), with moderate heterogeneity (I² = 59%, p = 0.005) (Fig. 2 A). In subgroup analysis by fixation method, suture fixation yields a pooled OR of 0.37 (95% CI: 0.19–0.69; p = 0.002), and OTSC fixation yields a pooled OR of 0.25 (95% CI: 0.11–0.54; p = 0.0004). There is no statistically significant difference between the reported fixation techniques (P = 0.45, I² = 0%) (Fig. 2 B). Leave-one-out sensitivity analysis shows a pooled OR of 0.30 (95% CI: 0.22–0.41; p < 0.00001), with no observed heterogeneity (I² = 0%) ( Figure S2 ). A funnel plot assessing publication bias is presented in Figure S3 . Clinical Success Six comparative studies evaluated clinical success rates, defined as relief of obstruction without the need for further intervention, in the fixation versus no-fixation groups. The pooled OR is 1.96 (95% CI: 1.37–2.79; p = 0.0002), with no observed heterogeneity (I² = 0%, p = 0.69) (Fig. 3 A). Subgroup analysis by fixation method shows a pooled OR of 1.93 (95% CI: 1.29–2.91) for suture fixation and 2.02 (95% CI: 1.20–3.39) for OTSC fixation. There is no statistically significant difference between the fixation techniques (P = 0.90, I² = 0%) (Fig. 3 B). Adverse Events Six studies reported the incidence of adverse events in patients undergoing stent fixation compared to no fixation. The pooled OR is 0.71 (95% CI: 0.33–1.54), with heterogeneity reported as I² = 73% (p = 0.002) (Fig. 4 A). Subgroup analysis shows a pooled OR of 0.89 (95% CI: 0.40–1.99; I² = 71%) for suture fixation and 0.37 (95% CI: 0.10–1.32; I² = 65%) for OTSC fixation, with no significant subgroup difference (p = 0.25) (Fig. 4 B). Leave-one-out sensitivity analysis for suture fixation yields a pooled OR of 0.63 (95% CI: 0.33–1.20; p = 0.16), with I² = 44% ( Figure S4 ). 4. Discussion In this study, we compared stent fixation using either endoscopic suture fixation or OTSC to no fixation across the entire gastrointestinal tract, with different indications. Overall, stent fixation significantly reduced its migration rates, and employing either endoscopic suture fixation or OTSC reported comparable results. Additionally, both interventions were significantly associated with higher rates of clinical success. Adverse event rates were generally lower in the fixation groups, with lower events in the OTSC clips compared to the endoscopic suture fixation. According to the fixation method subgroup analysis, the two techniques were comparable, with no reported statistically significant difference. Our findings oppose the study conducted by Park et al., as they reported statistically significant lower migration rates in the OTSC treated group compared to both suture fixation or free stents.( 27 ) Our findings, however, align with that reported by Mehta et al.( 21 ) Major factors influenced these differences. As Park et al. conducted their study on colonic stents, Mehta et al.'s study was on benign upper gastrointestinal conditions. Park et.al. reported much higher stent migration rates compared to Mehta et.al. and other clinical reports.( 17 , 27 – 29 ) Two hundred seven patients achieved clinical success in the intervention group compared to 147 in the control group. These findings align with previous reports.( 26 , 27 ) The clinical effectiveness of stent therapy is influenced by multiple factors, not solely by stent dwell time or migration. These additional elements likely explain why the disparity in clinical success rates between the no fixation and fixation groups was less pronounced than that in stent migration rates. Endoscopic suture fixation and OTSC were comparable in the reported clinical success rates. In terms of cost-effectiveness, Mehta et al.( 21 ) reported that using OTSC offers a cost advantage over endoscopic suture fixation. In the United States, OTSC fixation cost $ 649, while the Overstitch system was around $ 1500, including the device, two sutures, and cinches. The OTSC works with the same single-channel gastroscope for stent placements, while Overstitch requires a dual-channel gastroscope, incurring additional scope reprocessing expenses.( 18 ) Several risk factors were identified across the included studies. Ngamruengphong et al.( 17 ) reported higher migration rates with a stent length of more than 12 cm (OR: 2.63, 95% CI: 1.33–5.19), stent diameter (≤ 18 mm vs. >18 mm) (OR: 2.12, 95% CI: 1.11–4.05), and prior history of stent migration (OR: 2.87, 95% CI: 1.41–5.84). Mehta et al.( 21 ) reported that a stent length of more than 12 cm was associated with a significant risk of stent migration (OR: 2.17, 95% CI: 1.18–3.97). The strength of this study lies in following the PRISMA guideline, using reliable quality assessment tools, and conducting accurate analysis. The variability in the settings of the included studies supports the generalization of the results. The included studies reported low risk of bias, strengthening the credibility of the findings. Moreover, the larger sample size limited the distribution and variance errors. Our study faced several limitations: ( 1 ) the retrospective nature of the included studies and the limited number of clinical trials, ( 2 ) the endoscopists’ experience is variable among the included studies, which may have impacted our findings, and ( 3 ) risk factors of stent migration were not well addressed. These results support the utilization of stent fixation, however, future trials addressing the points of limitations and longer follow-up durations are recommended. 5. Conclusion Our study suggests that stent fixation using either the endoscopic suturing fixation or OTSC could significantly reduce the stent migration rate, with higher clinical success rates compared to the no fixation group. No significant difference in the incidence of adverse events was detected between the two groups. Further trials with long follow-up periods are needed. Declarations Author contribution AAA, AEA, RM: conceptualization and methodology. AAA, EA, AB and YN: investigation and data curation. AAA and DAE: formal analysis. AAA, YMH, AMZ, BME and MAB: Writing - Original Draft. AAA: Supervision. AAA: Project administration. AAMH, MAA, BME, and FSM: Writing - Review & Editing. All authors read and approved the final content. Ethical Approval Not applicable Competing interests The authors have no conflicts of interest to declare. Funding No funding was received. Availability of data and materials All data generated or analyzed during this study are included in this published article. References Wright A, Chang A, Bedi AO, Wamsteker EJ, Elta G, Kwon RS, et al. Endoscopic suture fixation is associated with reduced migration of esophageal fully covered self-expandable metal stents (FCSEMS). Surg Endosc. 2017;31(9):3489–94. Singer JL, Aryaie AH, Fayezizadeh M, Lash J, Marks JM. Predictive Factors for the Migration of Endoscopic Self-Expanding Metal Stents Placed in the Foregut. Surg Innov. 2017;24(4):353–7. Sharaiha RZ, Kumta NA, Doukides TP, Eguia V, Gonda TA, Widmer JL, et al. 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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-7457023","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Systematic Review","associatedPublications":[],"authors":[{"id":507861278,"identity":"cc76f7b2-b91d-400e-bb64-e569e887871f","order_by":0,"name":"Abdelaziz A. 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Elmarzouky","email":"","orcid":"","institution":"Zagazig University","correspondingAuthor":false,"prefix":"","firstName":"Doaa","middleName":"A.","lastName":"Elmarzouky","suffix":""},{"id":507861284,"identity":"13a6a49b-fecc-499c-99ef-2ea156e9e075","order_by":5,"name":"Amira A. Albawri","email":"","orcid":"","institution":"University of Science and Technology","correspondingAuthor":false,"prefix":"","firstName":"Amira","middleName":"A.","lastName":"Albawri","suffix":""},{"id":507861286,"identity":"0c57dbde-9430-4538-b326-10fe7099d4d2","order_by":6,"name":"Yara M. Harash","email":"","orcid":"","institution":"Hama University","correspondingAuthor":false,"prefix":"","firstName":"Yara","middleName":"M.","lastName":"Harash","suffix":""},{"id":507861289,"identity":"a22a44e8-ae1f-428b-b3a5-bddab0a40bd5","order_by":7,"name":"Ali M. Othman","email":"","orcid":"","institution":"Kafrelsheikh University","correspondingAuthor":false,"prefix":"","firstName":"Ali","middleName":"M.","lastName":"Othman","suffix":""},{"id":507861290,"identity":"3ca63f3c-79b2-4502-b510-e98881c73c72","order_by":8,"name":"Alaa E. Ali","email":"","orcid":"","institution":"Ain Shams University","correspondingAuthor":false,"prefix":"","firstName":"Alaa","middleName":"E.","lastName":"Ali","suffix":""},{"id":507861291,"identity":"685abf5e-71ba-48a7-a121-66e3f73e9c4d","order_by":9,"name":"Manar A. Balouz","email":"","orcid":"","institution":"Menoufia University","correspondingAuthor":false,"prefix":"","firstName":"Manar","middleName":"A.","lastName":"Balouz","suffix":""},{"id":507861292,"identity":"a6476070-94fb-488b-9987-4c6d8ac59b1e","order_by":10,"name":"Ahmed Abdelgayed M. Hussein","email":"","orcid":"","institution":"Al Azhar University","correspondingAuthor":false,"prefix":"","firstName":"Ahmed","middleName":"Abdelgayed M.","lastName":"Hussein","suffix":""},{"id":507861293,"identity":"9c075648-242c-4288-8efa-9652ef772540","order_by":11,"name":"Fatma S. Ahmed","email":"","orcid":"","institution":"Ain Shams University","correspondingAuthor":false,"prefix":"","firstName":"Fatma","middleName":"S.","lastName":"Ahmed","suffix":""},{"id":507861294,"identity":"1c8ce457-5b1c-4151-b128-b4ff21cefd07","order_by":12,"name":"Mohammed A. Alaeb","email":"","orcid":"","institution":"University of Tripoli","correspondingAuthor":false,"prefix":"","firstName":"Mohammed","middleName":"A.","lastName":"Alaeb","suffix":""},{"id":507861295,"identity":"b2137a6f-d698-47b8-99bf-0b4432145431","order_by":13,"name":"Basma M. El-Khalifa","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABBElEQVRIiWNgGAWjYFACHjDJuAFMGdTIgagDD4jXUnDMGKwlgXgtH5gTG0A0Pi267b0HP93MsZHdzn786YYfBmzp88MOPwTaYien24Bdi9mZc8nSudvSjHf25Jjd7DGQyd14O80AqCXZ2OwADi03cgyAWg4nbjiQw3aDx4Atd+PsBJCWA4nbcGsx/p277X/ihvPPn938Y8Ccbjg7/QMhLWZAWw4kbriRYHabx4A5QV46h4AtZ86YWeduSzbeOeON2W0Zg2OGG6RzCg4kGODxy/Ee49u52+xkt/OnP7v55k+NvPzs9M0fPlTYyeHSggkMwCoNiFUOAvINpKgeBaNgFIyCkQAA8+lsCMs02dUAAAAASUVORK5CYII=","orcid":"","institution":"Damietta University","correspondingAuthor":true,"prefix":"","firstName":"Basma","middleName":"M.","lastName":"El-Khalifa","suffix":""},{"id":507861296,"identity":"b3b21ce9-0907-4f7b-bcce-d8da6e218fe8","order_by":14,"name":"Rana Megawer","email":"","orcid":"","institution":"Minia University","correspondingAuthor":false,"prefix":"","firstName":"Rana","middleName":"","lastName":"Megawer","suffix":""}],"badges":[],"createdAt":"2025-08-25 21:23:11","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7457023/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7457023/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":90895345,"identity":"81bf4e7a-f0c6-49ed-bece-fef9fc7b9f9d","added_by":"auto","created_at":"2025-09-09 11:32:52","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":79681,"visible":true,"origin":"","legend":"\u003cp\u003ePRISMA flow diagram\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-7457023/v1/d002124ca2027b9737981149.png"},{"id":90895337,"identity":"7b964f50-814d-4efd-b4ac-16e4cc311971","added_by":"auto","created_at":"2025-09-09 11:32:52","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":536663,"visible":true,"origin":"","legend":"\u003cp\u003eStent migration rate meta-analysis\u003c/p\u003e","description":"","filename":"Onlinefloatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-7457023/v1/516cbb4b1c309d2c999214f1.png"},{"id":90895357,"identity":"570a4773-78cc-4b3d-aa82-b761dc61a2ef","added_by":"auto","created_at":"2025-09-09 11:32:52","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":400929,"visible":true,"origin":"","legend":"\u003cp\u003eClinical Success meta-analysis\u003c/p\u003e","description":"","filename":"Onlinefloatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-7457023/v1/a018a45101b53e20c65d0319.png"},{"id":90897312,"identity":"e1992837-7b89-486a-b787-f7150d2c74d6","added_by":"auto","created_at":"2025-09-09 11:40:51","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":422448,"visible":true,"origin":"","legend":"\u003cp\u003eAdverse events meta-analysis\u003c/p\u003e","description":"","filename":"Onlinefloatimage4.png","url":"https://assets-eu.researchsquare.com/files/rs-7457023/v1/0cc224bb2a9aff84006b8055.png"},{"id":101295595,"identity":"5229bbd0-44f2-49ec-918d-2f465da64b0d","added_by":"auto","created_at":"2026-01-28 08:58:28","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2611299,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7457023/v1/c8488285-f9f5-44b9-8b08-d1e6c2cc1d1b.pdf"},{"id":90895329,"identity":"2dc43e20-4bc7-4533-a0aa-401789e0a0bb","added_by":"auto","created_at":"2025-09-09 11:32:51","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":328651,"visible":true,"origin":"","legend":"","description":"","filename":"supp.docx","url":"https://assets-eu.researchsquare.com/files/rs-7457023/v1/dc2d00fccabcf3986ca533a6.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Stent fixation could reduce the stent migration rate: a comprehensive systematic review and meta-analysis","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003eAdvanced malignancies and benign strictures can be complicated with gastrointestinal tract (GIT) obstruction, presenting with severe manifestations as dysphagia. Endoscopic placement of self-expandable metal stents (SEMS) is a well-established, minimally invasive intervention to restore luminal patency in these patients, and it is routinely used in a variety of malignant and benign GI conditions.(\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) However, a major drawback of SEMS\u0026mdash;particularly fully covered stents chosen for benign indications\u0026mdash;is the risk of stent migration. Stent migration is the most common stent-related complication, with reported incidence ranging from approximately 30\u0026ndash;60% in patients with fully covered stents.(\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) A migrated stent can lead to therapy failure and often necessitates additional endoscopic procedures for repositioning or removal, imparting further morbidity and healthcare burden.(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eIn response to the high migration rates, various endoscopic fixation techniques have been developed to secure fully covered self-expanding metal stents (FCSEMS) in place. Among these, endoscopic suturing and over-the-scope clip (OTSC) placement are the most widely adopted techniques. Emerging evidence from retrospective studies indicates that such fixation can substantially reduce migration rates. In esophageal stenting, endoscopic suture fixation has been shown to significantly reduce the migration incidence to roughly 10\u0026ndash;20%.(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) Similarly, OTSC anchoring of FCSEMS has demonstrated markedly lower migration frequencies; one study reported an 8% migration rate with OTSC fixation versus 35% without fixation in esophageal stents.(\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e) Both techniques have exhibited high technical success with minimal device-related adverse events, and some reports suggest that preventing stent migration through fixation may also improve overall clinical success of the therapy by maintaining stent patency until the underlying condition is resolved.(\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e, \u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eDespite these advances, literature yields inconsistent results, and no clear consensus has been reached on the necessity or optimal method of stent fixation. Notably, one retrospective series found no significant difference in migration rates between fixed or free stents,(\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) suggesting that routine anchoring might not always confer benefit. Another comparative study reported that an OTSC fixation device achieved significantly lower migration rates than either suturing or no fixation, highlighting a potential advantage of clip fixation over sutures in certain settings.(\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e) The heterogeneity of findings may be influenced by differences in study populations (e.g. esophageal vs. colonic stents, benign vs. malignant etiologies) and varying methodologies. Moreover, the existing evidence is based mainly on single-center retrospective studies without randomized trials, which limits definitive conclusions. These limitations and conflicting outcomes in literature underscore a gap in knowledge and a lack of consensus regarding whether stent fixation should be routinely performed and which fixation strategy is superior.\u003c/p\u003e\u003cp\u003eThis systematic review and meta-analysis aims to evaluate the outcomes of fixation versus no fixation for gastrointestinal stents, specifically analyzing stent migration, clinical success, and adverse events across different fixation techniques.\u003c/p\u003e"},{"header":"2. Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003e2.1 Information Sources and Search Strategy\u003c/h2\u003e\u003cp\u003eA systematic search was conducted across available databases: PubMed, Scopus, and Web of Science, aiming to include relevant published clinical trials from their inception to January 2025. We used a specific search strategy using specific keywords, employing the MeSH indexing tool. The full details of the used search strategy are reported in \u003cb\u003eTable \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e\u003c/b\u003e.\u003c/p\u003e\u003cp\u003eThis was followed by title and abstract screening using Rayyan.(\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e) Eligible studies entered full text screening. The screening process was conducted by two independent reviewers, with conflicts being resolved by the main author. The study relied on the Cochrane Handbook of Systematic Reviews and Meta-analysis,(\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) while following the PRISMA statement guidelines in writing the systematic review.(\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec4\" class=\"Section2\"\u003e\u003ch2\u003e2.2 Eligibility Criteria\u003c/h2\u003e\u003cp\u003e\u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003eInclusion criteria\u003c/span\u003e\u003c/p\u003e\u003cp\u003eStudies, regardless of the design, were deemed eligible according to the following criteria:\u003c/p\u003e\u003cp\u003e\u003col\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003ePopulation: adults patients between the age of 18 and 80 years old, referred for stent placement for any GIT indication.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eIntervention (s): stent fixation using either the endoscopic suture fixation or OTSC.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eComparator (s): no fixation.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003cspan\u003e\u003cli\u003e\u003cp\u003eOutcomes: stent migration, clinical success, and adverse events rates.\u003c/p\u003e\u003c/li\u003e\u003c/span\u003e\u003c/ol\u003e\u003c/p\u003e\u003cp\u003e\u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003eExclusion criteria\u003c/span\u003e\u003c/p\u003e\u003cp\u003eNon-English full-text, experimental animal studies, case reports, reviews, editorials, abstracts, conference presentations, unattainable full-text and overlapping data were excluded.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003e2.3 Data Extraction\u003c/h2\u003e\u003cp\u003eData from the qualifying studies were extracted onto uniform data extraction sheets by two independent reviewers, followed by cross-checking and solving any disparities. The following data were extracted in separate sheets: characteristics of the included studies ( study ID, study design, location, sample size, age, gender, main condition, and fixation method), and the reported clinical outcomes (stent migration, clinical success, and adverse events rates).\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec6\" class=\"Section2\"\u003e\u003ch2\u003e2.4 Quality assessment\u003c/h2\u003e\u003cp\u003eThe quality of the included randomized controlled trials (RCTs) was assessed by two independent reviewers, using the Cochrane Collaboration\u0026rsquo;s Risk of Bias Tool (version 2).(\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e) These five domains have been investigated: the randomization process, deviations from the intended interventions, missing outcome data, outcome measurement, and selection of the reported results. Investigators categorize their judgments as \u0026ldquo;High risk\u0026rdquo;, \u0026ldquo;Low risk\u0026rdquo;, or \u0026ldquo;some concerns\u0026rdquo; of bias for each domain. A third investigator addressed and resolved any disagreements that arose. ROBINS 1 quality assessment tool was utilized for the included non-randomized controlled trials.(\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e) It investigates the following domains: risk of bias due to confounding, bias in classification of interventions, bias in selection of participants into the study (or into the analysis), deviations from intended interventions, missing data, bias arising from measurement of the outcomes, and bias in selection of the reported results. The Newcastle Ottawa scale (NOS) was utilized to assess the quality of the included observational studies, across the following domains: potential bias arising from the study participants' selection, the groups' comparability, and the ascertainment of the outcome.(\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e)\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\u003ch2\u003e2.5 Statistical analysis\u003c/h2\u003e\u003cp\u003eDichotomous data were pooled as odds ratio (OR) with a 95% confidence interval (CI). RevMan 5.4 for Windows was used for all statistical analyses and forest plot generation. (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e) Fixed models were used if there was no statistically significant heterogeneity, and random models were used otherwise.\u003c/p\u003e\u003cp\u003eWe visually inspected the forest plots to evaluate potential statistical heterogeneity across the included studies. The Chi-square test, also referred to as the Cochrane Q test, along with Higgins and Thompson's I2 (calculated as I2 = ((Q-df)/Q) x 100%), was utilized to quantify this heterogeneity. A p-value below 0.1 from the chi-square test deemed it statistically significant. Levels were categorized as low, moderate, and high based on I2 values below 25%, 25\u0026ndash;75%, and above 75%, respectively.(\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e) We performed a sensitivity analysis (leave-one-out test) in an attempt to resolve any existing heterogeneity.\u003c/p\u003e\u003c/div\u003e"},{"header":"3. Results","content":"\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\u003ch2\u003e3.1 Literature search\u003c/h2\u003e\u003cp\u003eOur literature search identified 3583 citations through the used domains. Title and abstract screening resulted in the exclusion of 3500 studies. Eighty-three studies were eligible for full-text screening. Subsequently, 71 records were excluded. Twelve studies met the eligibility criteria for this systematic review. Details of the search results are reported in the reported PRISMA flow diagram, shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec10\" class=\"Section2\"\u003e\u003ch2\u003e3.2 Characteristics of the included studies\u003c/h2\u003e\u003cp\u003eTwelve studies are reported in our review, including three RCTs, one non-randomized clinical trials, one pilot trial, and seven retrospective cohort studies.(\u003cspan additionalcitationids=\"CR16 CR17 CR18 CR19 CR20 CR21 CR22 CR23 CR24 CR25\" citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e) The mean age of the included population ranged between 50 and 77.5 years. Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e shows the characteristics of the included studies.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003eCharacteristics of the included studies:\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"10\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c7\" colnum=\"7\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c8\" colnum=\"8\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c9\" colnum=\"9\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c10\" colnum=\"10\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eStudy ID\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eStudy design\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c4\" namest=\"c3\"\u003e\u003cp\u003eSample size\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c6\" namest=\"c5\"\u003e\u003cp\u003eAge, mean (SD)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003eSex, n (male %)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c9\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eMain disease\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c10\" morerows=\"1\" rowspan=\"2\"\u003e\u003cp\u003eFixation method\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003e\u003cb\u003eIntervention\u003c/b\u003e\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c4\"\u003e\u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c5\"\u003e\u003cp\u003e\u003cb\u003eIntervention\u003c/b\u003e\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c6\"\u003e\u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c7\"\u003e\u003cp\u003e\u003cb\u003eIntervention\u003c/b\u003e\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c8\"\u003e\u003cp\u003e\u003cb\u003eControl\u003c/b\u003e\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSiddiqui 2016\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRetrospective cohort\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e26\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e67\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e69.9\u0026thinsp;\u0026plusmn;\u0026thinsp;11.8\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e66.9\u0026thinsp;\u0026plusmn;\u0026thinsp;11\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e17 (65)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e51 (76)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003eEsophageal cancer\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003eEndoscopic suture\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSharaiha 2014\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRetrospective cohort\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e17\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e20\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e55.7\u0026thinsp;\u0026plusmn;\u0026thinsp;15.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e58.5\u0026thinsp;\u0026plusmn;\u0026thinsp;17.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colspan=\"2\" nameend=\"c8\" namest=\"c7\"\u003e\u003cp\u003e18 (48.65)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003eEsophageal strictures and leaks\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003eEndoscopic suture\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMehta 2024\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRetrospective cohort\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eSF\u0026thinsp;=\u0026thinsp;94, ES\u0026thinsp;=\u0026thinsp;95\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e122\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eSF= 62\u0026thinsp;\u0026plusmn;\u0026thinsp;14, ES\u0026thinsp;=\u0026thinsp;56\u0026thinsp;\u0026plusmn;\u0026thinsp;16\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e60\u0026thinsp;\u0026plusmn;\u0026thinsp;16\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eSF\u0026thinsp;=\u0026thinsp;47(50), ES= 47(49)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e60(49)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003eNonmalignant strictures, fistulas, perforations, leaks, and variceal bleeding\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003eEndoscopic suture and Over-the-scope clips\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNgamruengphong 2017\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRetrospective cohort\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e46\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e28\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e54\u0026thinsp;\u0026plusmn;\u0026thinsp;17\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e50\u0026thinsp;\u0026plusmn;\u0026thinsp;15\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e21(46)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e12(43)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003eUpper gastrointestinal conditions, defined as strictures, fistulae, leaks and perforations\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003eEndoscopic suture\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eDuBroff 2025\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRetrospective cohort\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e27\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e28\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e-\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e16 (49)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e18 (64)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003eBoth benign and malignant upper esophageal conditions\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003eClips with anchor prongs\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSchiemer 2022\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRetrospective cohort\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e26\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e51\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e66.6\u0026thinsp;\u0026plusmn;\u0026thinsp;16\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e66.3\u0026thinsp;\u0026plusmn;\u0026thinsp;12.2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e19 (73.1)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e36 (70.6)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003eBoth benign and malignant upper esophageal conditions\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003eOver-the-scope clips\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eObaitan 2021\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRetrospective cohort\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e23\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e91\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e56.25\u0026thinsp;\u0026plusmn;\u0026thinsp;18.41\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e56.25\u0026thinsp;\u0026plusmn;\u0026thinsp;13.59\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e18 (78.26)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e58 (63.74)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003ePost-operative leak, Tracheo-esophageal fistula, Endoscopic perforation, Food impaction, Esophago-pleural fistula, Malignant stricture, Boerhaave\u0026rsquo;s syndrome, Unknown cause\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003eEndoscopic suture\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eVanbiervliet 2011\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003ePilot comparative study\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e23\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e21\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e63.6\u0026thinsp;\u0026plusmn;\u0026thinsp;17.7\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e67.3\u0026thinsp;\u0026plusmn;\u0026thinsp;17.4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e12 (52)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e13 (62)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003eEsophageal stricture, Fistulas and perforations\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003eClips\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRieder 2017\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eClinical trial\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003eEndoscopic clip group\u0026thinsp;=\u0026thinsp;5. Suture fixation gorup\u0026thinsp;=\u0026thinsp;4\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e2\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003eClip\u0026thinsp;=\u0026thinsp;67.4\u0026thinsp;\u0026plusmn;\u0026thinsp;19.642, Suture\u0026thinsp;=\u0026thinsp;57\u0026thinsp;\u0026plusmn;\u0026thinsp;18.708\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e77.5\u0026thinsp;\u0026plusmn;\u0026thinsp;2.121\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003eClip\u0026thinsp;=\u0026thinsp;2 (40), Suture- 1 (\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e1 (50)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003eAchalasia\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003eClips and sutures\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eNgamruengphong 2016\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRetrospective cohort\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e81\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e44\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e59\u0026thinsp;\u0026plusmn;\u0026thinsp;16\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e54\u0026thinsp;\u0026plusmn;\u0026thinsp;18\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e19(43)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e48(59)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003eBenign esophageal. Gastric and duedenal pathology\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003eEndoscopic suture\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eSingh 2025\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRandomized controlled trials\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e24\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e22\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u003cp\u003e63.08\u0026thinsp;\u0026plusmn;\u0026thinsp;10.44\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u003cp\u003e68.17\u0026thinsp;\u0026plusmn;\u0026thinsp;11.49\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u003cp\u003e17 (70.8)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u003cp\u003e16 (72.7)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003eEsophageal strictures\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003eEndoscopic suture\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eThiruvengadam 2021\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003eRetrospective cohort\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e22\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e\u003cp\u003e5\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c5\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c7\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c8\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c9\"\u003e\u003cp\u003enonbariatric nonesophageal gastroenteric\u003c/p\u003e\u003cp\u003e foregut leaks\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c10\"\u003e\u003cp\u003eSuture\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003ctfoot\u003e\u003ctr\u003e\u003ctd colspan=\"10\"\u003eQualitative data are presented as mean (standard deviation). Quantitative data are presented as number (percentage).\u003c/td\u003e\u003c/tr\u003e\u003c/tfoot\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e\u003ch2\u003e3.3 Quality assessment results:\u003c/h2\u003e\u003cp\u003eUsing NOS, the quality of the included cohorts was deemed good, with scores ranging between six and nine (\u003cb\u003eTable S2)\u003c/b\u003e. The trials included were of high quality, except one rasing some concerns due to confounding bias (\u003cb\u003eFigure \u003cspan refid=\"MOESM1\" class=\"InternalRef\"\u003eS1\u003c/span\u003e\u003c/b\u003e).\u003c/p\u003e\u003c/div\u003e\u003cdiv id=\"Sec12\" class=\"Section2\"\u003e\u003ch2\u003e3.3 Meta-analysis\u003c/h2\u003e\u003cp\u003e\u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003eStent Migration\u003c/span\u003e\u003c/p\u003e\u003cp\u003eTwelve studies reported on stent migration rates with and without fixation. The pooled OR is 0.32 (95% CI: 0.19\u0026ndash;0.57; p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), with moderate heterogeneity (I\u0026sup2; = 59%, p\u0026thinsp;=\u0026thinsp;0.005) (Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e2\u003c/span\u003eA). In subgroup analysis by fixation method, suture fixation yields a pooled OR of 0.37 (95% CI: 0.19\u0026ndash;0.69; p\u0026thinsp;=\u0026thinsp;0.002), and OTSC fixation yields a pooled OR of 0.25 (95% CI: 0.11\u0026ndash;0.54; p\u0026thinsp;=\u0026thinsp;0.0004). There is no statistically significant difference between the reported fixation techniques (P\u0026thinsp;=\u0026thinsp;0.45, I\u0026sup2; = 0%) (Fig.\u0026nbsp;\u003cspan refid=\"Fig5\" class=\"InternalRef\"\u003e2\u003c/span\u003eB). Leave-one-out sensitivity analysis shows a pooled OR of 0.30 (95% CI: 0.22\u0026ndash;0.41; p\u0026thinsp;\u0026lt;\u0026thinsp;0.00001), with no observed heterogeneity (I\u0026sup2; = 0%) (\u003cb\u003eFigure S2\u003c/b\u003e). A funnel plot assessing publication bias is presented in \u003cb\u003eFigure S3\u003c/b\u003e.\u003c/p\u003e\u003cp\u003e\u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003eClinical Success\u003c/span\u003e\u003c/p\u003e\u003cp\u003eSix comparative studies evaluated clinical success rates, defined as relief of obstruction without the need for further intervention, in the fixation versus no-fixation groups. The pooled OR is 1.96 (95% CI: 1.37\u0026ndash;2.79; p\u0026thinsp;=\u0026thinsp;0.0002), with no observed heterogeneity (I\u0026sup2; = 0%, p\u0026thinsp;=\u0026thinsp;0.69) (Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e3\u003c/span\u003eA). Subgroup analysis by fixation method shows a pooled OR of 1.93 (95% CI: 1.29\u0026ndash;2.91) for suture fixation and 2.02 (95% CI: 1.20\u0026ndash;3.39) for OTSC fixation. There is no statistically significant difference between the fixation techniques (P\u0026thinsp;=\u0026thinsp;0.90, I\u0026sup2; = 0%) (Fig.\u0026nbsp;\u003cspan refid=\"Fig6\" class=\"InternalRef\"\u003e3\u003c/span\u003eB).\u003c/p\u003e\u003cp\u003e\u003cspan type=\"BoldUnderline\" class=\"BoldUnderline\" name=\"Emphasis\"\u003eAdverse Events\u003c/span\u003e\u003c/p\u003e\u003cp\u003eSix studies reported the incidence of adverse events in patients undergoing stent fixation compared to no fixation. The pooled OR is 0.71 (95% CI: 0.33\u0026ndash;1.54), with heterogeneity reported as I\u0026sup2; = 73% (p\u0026thinsp;=\u0026thinsp;0.002) (Fig.\u0026nbsp;\u003cspan refid=\"Fig7\" class=\"InternalRef\"\u003e4\u003c/span\u003eA). Subgroup analysis shows a pooled OR of 0.89 (95% CI: 0.40\u0026ndash;1.99; I\u0026sup2; = 71%) for suture fixation and 0.37 (95% CI: 0.10\u0026ndash;1.32; I\u0026sup2; = 65%) for OTSC fixation, with no significant subgroup difference (p\u0026thinsp;=\u0026thinsp;0.25) (Fig.\u0026nbsp;\u003cspan refid=\"Fig7\" class=\"InternalRef\"\u003e4\u003c/span\u003eB). Leave-one-out sensitivity analysis for suture fixation yields a pooled OR of 0.63 (95% CI: 0.33\u0026ndash;1.20; p\u0026thinsp;=\u0026thinsp;0.16), with I\u0026sup2; = 44% (\u003cb\u003eFigure S4\u003c/b\u003e).\u003c/p\u003e\u003c/div\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eIn this study, we compared stent fixation using either endoscopic suture fixation or OTSC to no fixation across the entire gastrointestinal tract, with different indications. Overall, stent fixation significantly reduced its migration rates, and employing either endoscopic suture fixation or OTSC reported comparable results. Additionally, both interventions were significantly associated with higher rates of clinical success. Adverse event rates were generally lower in the fixation groups, with lower events in the OTSC clips compared to the endoscopic suture fixation. According to the fixation method subgroup analysis, the two techniques were comparable, with no reported statistically significant difference.\u003c/p\u003e\u003cp\u003eOur findings oppose the study conducted by Park et al., as they reported statistically significant lower migration rates in the OTSC treated group compared to both suture fixation or free stents.(\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e) Our findings, however, align with that reported by Mehta et al.(\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) Major factors influenced these differences. As Park et al. conducted their study on colonic stents, Mehta et al.'s study was on benign upper gastrointestinal conditions. Park et.al. reported much higher stent migration rates compared to Mehta et.al. and other clinical reports.(\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e, \u003cspan additionalcitationids=\"CR28\" citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eTwo hundred seven patients achieved clinical success in the intervention group compared to 147 in the control group. These findings align with previous reports.(\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e, \u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e) The clinical effectiveness of stent therapy is influenced by multiple factors, not solely by stent dwell time or migration. These additional elements likely explain why the disparity in clinical success rates between the no fixation and fixation groups was less pronounced than that in stent migration rates. Endoscopic suture fixation and OTSC were comparable in the reported clinical success rates.\u003c/p\u003e\u003cp\u003eIn terms of cost-effectiveness, Mehta et al.(\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) reported that using OTSC offers a cost advantage over endoscopic suture fixation. In the United States, OTSC fixation cost \u003cspan\u003e$\u003c/span\u003e649, while the Overstitch system was around \u003cspan\u003e$\u003c/span\u003e1500, including the device, two sutures, and cinches. The OTSC works with the same single-channel gastroscope for stent placements, while Overstitch requires a dual-channel gastroscope, incurring additional scope reprocessing expenses.(\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eSeveral risk factors were identified across the included studies. Ngamruengphong et al.(\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e) reported higher migration rates with a stent length of more than 12 cm (OR: 2.63, 95% CI: 1.33\u0026ndash;5.19), stent diameter (\u0026le;\u0026thinsp;18 mm vs. \u0026gt;18 mm) (OR: 2.12, 95% CI: 1.11\u0026ndash;4.05), and prior history of stent migration (OR: 2.87, 95% CI: 1.41\u0026ndash;5.84). Mehta et al.(\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e) reported that a stent length of more than 12 cm was associated with a significant risk of stent migration (OR: 2.17, 95% CI: 1.18\u0026ndash;3.97).\u003c/p\u003e\u003cp\u003eThe strength of this study lies in following the PRISMA guideline, using reliable quality assessment tools, and conducting accurate analysis. The variability in the settings of the included studies supports the generalization of the results. The included studies reported low risk of bias, strengthening the credibility of the findings. Moreover, the larger sample size limited the distribution and variance errors. Our study faced several limitations: (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e) the retrospective nature of the included studies and the limited number of clinical trials, (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e) the endoscopists\u0026rsquo; experience is variable among the included studies, which may have impacted our findings, and (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e) risk factors of stent migration were not well addressed. These results support the utilization of stent fixation, however, future trials addressing the points of limitations and longer follow-up durations are recommended.\u003c/p\u003e"},{"header":"5. Conclusion","content":"\u003cp\u003eOur study suggests that stent fixation using either the endoscopic suturing fixation or OTSC could significantly reduce the stent migration rate, with higher clinical success rates compared to the no fixation group. No significant difference in the incidence of adverse events was detected between the two groups. Further trials with long follow-up periods are needed.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAuthor contribution\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAAA, AEA, RM: conceptualization and methodology. AAA, EA, AB and YN: investigation and data curation. AAA and DAE: formal analysis. AAA, YMH, AMZ, BME and MAB: Writing - Original Draft. AAA: Supervision. AAA: Project administration. AAMH, MAA, BME, and FSM: Writing - Review \u0026amp; Editing. All authors read and approved the final content.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical Approval\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors have no conflicts of interest to declare.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo funding was received.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003c/strong\u003eAll data generated or analyzed during this study are included in this published article.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eWright A, Chang A, Bedi AO, Wamsteker EJ, Elta G, Kwon RS, et al. Endoscopic suture fixation is associated with reduced migration of esophageal fully covered self-expandable metal stents (FCSEMS). Surg Endosc. 2017;31(9):3489\u0026ndash;94.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSinger JL, Aryaie AH, Fayezizadeh M, Lash J, Marks JM. Predictive Factors for the Migration of Endoscopic Self-Expanding Metal Stents Placed in the Foregut. Surg Innov. 2017;24(4):353\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSharaiha RZ, Kumta NA, Doukides TP, Eguia V, Gonda TA, Widmer JL, et al. Esophageal Stenting With Sutures: Time to Redefine Our Standards? J Clin Gastroenterol. 2015;49(6):e57\u0026ndash;60.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNgamruengphong S, Sharaiha RZ, Sethi A, Siddiqui AA, DiMaio CJ, Gonzalez S, et al. Endoscopic suturing for the prevention of stent migration in benign upper gastrointestinal conditions: a comparative multicenter study. Endoscopy. 2016;48(9):802\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePark KH, Lew D, Samaan J, Patel S, Liu Q, Gaddam S, et al. Comparison of no stent fixation, endoscopic suturing, and a novel over-the-scope clip for stent fixation in preventing migration of fully covered self-expanding metal stents: a retrospective comparative study (with video). Gastrointest Endosc. 2022;96(5):771\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePapaefthymiou A, Gkolfakis P, Basiliya K, Ramai D, Tziatzios G, Sehgal V, et al. Success rates of fixation techniques on prevention of esophageal stent migration: a systematic review and meta-analysis. Endoscopy. 2024;56(1):22\u0026ndash;30.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eOuzzani M, Hammady H, Fedorowicz Z, Elmagarmid A. Rayyan-a web and mobile app for systematic reviews. Syst Rev. 2016;5(1):210.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCumpston M, Li T, Page MJ, Chandler J, Welch VA, Higgins JP, et al. Updated guidance for trusted systematic reviews: a new edition of the Cochrane Handbook for Systematic Reviews of Interventions. Cochrane Database Syst Rev. 2019;2019(10):ED000142.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePage MJ, McKenzie JE, Bossuyt PM, Boutron I, Hoffmann TC, Mulrow CD, et al. The PRISMA 2020 statement: an updated guideline for reporting systematic reviews. BMJ. 2021;372:n71.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSterne JAC, Savović J, Page MJ, Elbers RG, Blencowe NS, Boutron I, et al. RoB 2: a revised tool for assessing risk of bias in randomised trials. BMJ. 2019;366:l4898.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGuo Z, Zhao Q, Huang S, Huang C, Wang D, Yang L, et al. Ischaemia-free liver transplantation in humans: a first-in-human trial. Lancet Reg Health - Western Pac. 2021;16:100260.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMamikutty R, Aly AS, Marhazlinda J. Selecting Risk of Bias Tools for Observational Studies for a Systematic Review of Anthropometric Measurements and Dental Caries among Children. IJERPH. 2021;18(16):8623.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eReview Manager (RevMan). The Cochrane Collaboration. 2020. ([Computer Program]).\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHiggins JPT, Thompson SG. Quantifying heterogeneity in a meta-analysis. Stat Med. 2002;21(11):1539\u0026ndash;58.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eThiruvengadam NR, Hamerski C, Nett A, Bhat Y, Shah J, Bernabe J, et al. Combination Endoscopic Therapy is Effective for Treatment of Nonbariatric Postoperative Gastroenteric Leaks. Techniques Innovations Gastrointest Endoscopy. 2021;23(2):122\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRieder E, Asari R, Paireder M, Lenglinger J, Schoppmann SF. Endoscopic stent suture fixation for prevention of esophageal stent migration during prolonged dilatation for achalasia treatment. Dis Esophagus. 2017;30(4):1\u0026ndash;6.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNgamruengphong S, Sharaiha R, Sethi A, Siddiqui A, DiMaio C, Gonzalez S, et al. Endoscopic suturing for the prevention of stent migration in benign upper gastrointestinal conditions: a comparative multicenter study. Endoscopy. 2016;48(09):802\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSingh S, Maan S, Hadi Y, Agrawal R, Adekolu AA, Cohen EM et al. Endoscopic suturing to prevent migration of esophageal fully covered self-expanding metal stents: a randomized controlled trial (with video). Gastrointestinal Endoscopy [Internet]. 2025 Feb [cited 2025 May 22]; Available from: \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://linkinghub.elsevier.com/retrieve/pii/S0016510725001397\u003c/span\u003e\u003cspan address=\"https://linkinghub.elsevier.com/retrieve/pii/S0016510725001397\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eYang J, Siddiqui AA, Kowalski TE, Loren DE, Khalid A, Soomro A, et al. Esophageal stent fixation with endoscopic suturing device improves clinical outcomes and reduces complications in patients with locally advanced esophageal cancer prior to neoadjuvant therapy: a large multicenter experience. Surg Endosc. 2017;31(3):1414\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSharaiha RZ, Kumta NA, Doukides TP, Eguia V, Gonda TA, Widmer JL, et al. Esophageal Stenting With Sutures: Time to Redefine Our Standards? J Clin Gastroenterol. 2015;49(6):e57\u0026ndash;60.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMehta A, Ashhab A, Shrigiriwar A, Assefa R, Canakis A, Frohlinger M, et al. Evaluating no fixation, endoscopic suture fixation, and an over-the-scope clip for anchoring fully covered self-expandable metal stents in benign upper GI conditions: a comparative multicenter international study (with video). Gastrointest Endosc. 2025;101(3):589\u0026ndash;97.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNgamruengphong S, Sharaiha R, Sethi A, Siddiqui A, DiMaio C, Gonzalez S, et al. Fully-covered metal stents with endoscopic suturing vs. partially-covered metal stents for benign upper gastrointestinal diseases: a comparative study. Endosc Int Open. 2018;06(02):E217\u0026ndash;23.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eDuBroff J, Holten D, Toy G, Jonason D, Ramai D, Morris J, et al. Reduced migration of esophageal fully covered self-expandable metal stents affixed with clips with anchor prongs. iGIE. 2025;4(1):38\u0026ndash;41.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSchiemer M, Bettinger D, Mueller J, Schultheiss M, Schwacha H, Hasselblatt P, et al. Reduction of esophageal stent migration rate with a novel over-the-scope fixation device (with video). Gastrointest Endosc. 2022;96(1):1\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eObaitan I, DeWitt JM, Bick BL, Calderon G, Patel F, Ghafoor A, et al. The addition of flexible endoscopic suturing to stenting for the management of transmural esophageal wall defects: a single tertiary center experience. Surg Endosc. 2021;35(11):6379\u0026ndash;89.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eVanbiervliet G, Filippi J, Karimdjee BS, Venissac N, Iannelli A, Rahili A, et al. The role of clips in preventing migration of fully covered metallic esophageal stents: a pilot comparative study. Surg Endosc. 2012;26(1):53\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003ePark KH, Lew D, Samaan J, Patel S, Liu Q, Gaddam S, et al. Comparison of no stent fixation, endoscopic suturing, and a novel over-the-scope clip for stent fixation in preventing migration of fully covered self-expanding metal stents: a retrospective comparative study (with video). Gastrointest Endosc. 2022;96(5):771\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLaw R, Prabhu A, Fujii-Lau L, Shannon C, Singh S. Stent migration following endoscopic suture fixation of esophageal self-expandable metal stents: a systematic review and meta-analysis. Surg Endosc. 2018;32(2):675\u0026ndash;81.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBick BL, Imperiale TF, Johnson CS, DeWitt JM. Endoscopic suturing of esophageal fully covered self-expanding metal stents reduces rates of stent migration. Gastrointest Endosc. 2017;86(6):1015\u0026ndash;21.\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":"","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":"Stent migration, stent fixation, endoscopic suturing, OTSC","lastPublishedDoi":"10.21203/rs.3.rs-7457023/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7457023/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eEndoscopic placement of self-expandable metal stents (SEMS) is a minimally invasive intervention, aiming to restore luminal patency in GIT obstruction patients. As stent migration is considered a major sequela, techniques for its fixation have been established. This study aims to assess the efficacy of stent fixation using either endoscopic suture fixation or over-the-scope clips (OTSC).\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eFollowing the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) guidelines, we searched available databases (PubMed, Scopus, and Web of Science) to identify eligible studies reported up to January 2025. Using RevMan 5.4, we reported outcomes as odds ratios (OR) and confidence intervals (CIs). A P-value\u0026thinsp;\u0026le;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eTwelve studies were included in this meta-analysis, with a total of 1136 patients. The pooled OR for stent fixation is 0.32 (95% CI: 0.19\u0026ndash;0.57; p\u0026thinsp;\u0026lt;\u0026thinsp;0.001), with moderate heterogeneity (I\u0026sup2; = 59%, P\u0026thinsp;=\u0026thinsp;0.005). According to the subgroup analysis in relation to the fixation method, suture fixation yields a pooled OR of 0.37 (95% CI: 0.19\u0026ndash;0.69; p\u0026thinsp;=\u0026thinsp;0.002), and OTSC fixation yields a pooled OR of 0.25 (95% CI: 0.11\u0026ndash;0.54; p\u0026thinsp;=\u0026thinsp;0.0004). There is no statistically significant difference between these subgroups (p\u0026thinsp;=\u0026thinsp;0.45, I\u0026sup2; = 0%). There was no statistically significant difference in the rates of adverse events; with a pooled OR of 0.71 (95% CI: 0.33\u0026ndash;1.54), and substantial heterogeneity (I\u003csup\u003e2\u003c/sup\u003e\u0026thinsp;=\u0026thinsp;73%; P\u0026thinsp;=\u0026thinsp;0.002).\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eStatistically significant lower stent migration rates were reported following either endoscopic suture fixation or OTSC, along with higher clinical success rates. Future clinical trials with longer follow-up durations are recommended to accurately update the guidelines.\u003c/p\u003e","manuscriptTitle":"Stent fixation could reduce the stent migration rate: a comprehensive systematic review and meta-analysis","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-09 11:32:45","doi":"10.21203/rs.3.rs-7457023/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":"25ca44bb-435c-45e0-9e6e-f4032a01a0cf","owner":[],"postedDate":"September 9th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2026-01-28T08:55:53+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-09 11:32:45","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7457023","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7457023","identity":"rs-7457023","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}