Real-World Validation of Guideline-Defined Curative Criteria After Endoscopic Submucosal Dissection for Early Gastrointestinal Cancers: An Indian Experience

Real-World Validation of Guideline-Defined Curative Criteria After Endoscopic Submucosal Dissection for Early Gastrointestinal Cancers: An Indian Experience | 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 Real-World Validation of Guideline-Defined Curative Criteria After Endoscopic Submucosal Dissection for Early Gastrointestinal Cancers: An Indian Experience Shrihari Anil Anikhindi, Sunayana Misra, Noriya Uedo, Shivam Khare, and 9 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8568642/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 9 You are reading this latest preprint version Abstract Aims and Background: Endoscopic submucosal dissection (ESD) is an effective alternative to surgery for early gastrointestinal (GI) cancers. Curative and non-curative ESD criteria are primarily derived from high-volume centres within structured screening programs, where pathological assessment guides post-resection management. However, real-world validation of these criteria in routine clinical practice, particularly in centres with evolving ESD expertise, remains limited. We evaluated outcomes of ESD-treated early GI cancers using standard guideline-defined curative criteria in a tertiary-care centre in India. Methods: This retrospective descriptive study included patients with early epithelial GI cancers (pTis–pT1) treated by ESD a tertiary care centre. Resected specimens were processed using International Collaboration on Cancer Reporting datasets and classified as curative or non-curative according to European Society of Gastrointestinal Endoscopy and Japan Gastroenterological Endoscopy Society criteria. Clinical outcomes, additional therapy, follow-up status analysed. Results: Seventeen early GI cancers underwent ESD, with en-bloc resection achieved in 88%. After excluding two indeterminate resections, curative ESD was achieved in 60% (9/15). Median follow-up was 18 months (range 6–36 months). All patients with curative ESD remained disease-free without additional therapy. Non-curative ESD occurred in 40% (6/15), leading to additional surgery or locoregional therapy in 29% (5/17). Residual tumour was identified in three patients, and lymph node metastasis was detected in one patient despite absence of residual primary tumour. Conclusions: Application of standard guideline-based curative criteria in routine Indian clinical practice reliably predicted outcomes and guided post-resection management, supporting the generalizability of established ESD decision frameworks beyond expert screening-based settings. Curative ESD Endoscopic Submucosal Dissection Early Gastrointestinal Cancer Non-Curative ESD Pathology Figures Figure 1 Introduction Early gastrointestinal (GI) cancers are increasingly detected at an early stage due to advances in imaging, effective screening strategies, and heightened clinical awareness. This has also advanced the field of endoscopic resections. Endoscopic submucosal dissection (ESD) is an effective technique for managing selected early GI cancers, enabling en bloc resection of lesions and often serving as a viable alternative to surgery [1,2]. Compared with piecemeal resections, ESD facilitates accurate assessment of resection margins, depth of invasion, and other adverse histological features, which are critical determinants of oncologic risk. Existing data and experience, predominantly from expert centres in East Asia and increasingly from the West, have shown that ESD offers oncologic outcomes comparable to surgical resection for appropriately selected lesions while preserving organ function and reducing morbidity [3]. Thus, ESD is incorporated into most management algorithms for early cancers of the oesophagus, stomach, and colon worldwide [4,5]. The true clinical value of ESD lies not only in en bloc resection but also in its ability to provide definitive pathological assessment and risk stratification that guide subsequent management [6]. Contemporary international guidelines, including those from the Japan Gastroenterological Endoscopy Society (JGES) and the European Society of Gastrointestinal Endoscopy (ESGE), have defined standard pathological criteria to classify ESD as curative or non-curative based on features such as margin status, depth of submucosal invasion, lymphovascular invasion, tumor differentiation, and tumor budding [2,7,8]. This classification is pivotal for deciding the post-ESD management paradigm, including the need for additional surgery or locoregional therapy. Majority of outcome data supporting these criteria originates from high-volume expert centres operating within structured population-based screening programs. Utility of these guidelines in routine real-world practice in countries like India, with differing screening strategies, disease presentation, and healthcare pathways, is underexplored [5,7]. To confirm the generalizability and clinical validity of existing ESD decision frameworks, it is essential to evaluate outcomes in this context. The present study was therefore undertaken to evaluate the real-world clinical validity of standard guideline-defined curative criteria following ESD for early GI cancers in a tertiary-care center in India. Background Early gastrointestinal cancers can often be cured with organ-preserving endoscopic therapy when detected at an early stage. Endoscopic submucosal dissection enables en bloc resection and provides detailed pathological assessment, which is central to post-resection risk stratification. International guidelines from the European Society of Gastrointestinal Endoscopy and the Japan Gastroenterological Endoscopy Society define standardized criteria to classify ESD as curative or non-curative and guide decisions regarding surveillance or additional oncologic treatment [2,7]. However, these criteria are primarily derived from high-volume expert centres within structured screening programs, and their performance in routine clinical practice remains less well established [5]. In countries such as India, where early GI cancers are detected opportunistically and ESD programs are still evolving, the real-world applicability of these guidelines is uncertain. This study therefore aimed to validate guideline-defined curative and non-curative ESD criteria in an Indian tertiary-care setting by correlating standardized pathological classification with clinical outcomes, providing pragmatic evidence for their use in routine practice. Methods Study Design and Patient Selection: This retrospective observational study was conducted at a tertiary-care referral centre in India. All consecutive patients with histologically confirmed early epithelial gastrointestinal (GI) cancers (pathological stage pTis–pT1) who underwent ESD as primary therapy from January 2020 to December 2024 were eligible for inclusion. Lesions involving the esophagus, stomach, and colorectum were included. Patients undergoing endoscopic mucosal resection, polypectomy, or surgical resection as initial therapy were excluded, as were benign lesions and subepithelial tumors. The analysis was designed as a real-world, hypothesis-generating validation study, focusing on the clinical performance of guideline-defined curative and non-curative criteria following endoscopic submucosal dissection (ESD), rather than on comparative efficacy or volume-based outcomes. All patients underwent ESD as primary therapy without neoadjuvant treatment. Endoscopic Technique: ESD procedures were performed by experienced endoscopists using standard techniques and electrosurgical knives. Lesions were carefully delineated using high-definition white light endoscopy and image-enhanced modalities. The procedural goal was en bloc resection with adequate lateral and vertical margins. Pathological Processing and Evaluation: All specimens were handled using standardised grossing protocols by experienced GI histopathologists. Resected specimens were pinned mucosal-side up to prevent curling, fixed in formalin, inked at resection margins, and serially sectioned at 2–3 mm intervals. Histopathological evaluation was performed using standardised ICCR datasets specific to esophageal, gastric, and colorectal endoscopic resection specimens [ 3 , 9 ]. Parameters assessed included histologic subtype and grade, depth of invasion using site-specific microstaging systems, horizontal and vertical margin status, lymphovascular invasion, perineural invasion, and tumour budding in colorectal cancers [ 10 ]. Ancillary immunohistochemical stains were employed when required. Definitions and Follow-Up: Curative and non-curative ESD were defined in accordance with ESGE and JGES criteria [ 2 , 7 , 11 ]. Patients were discussed in multidisciplinary team meetings, and recommendations for additional therapy were individualised based on pathological risk stratification. Follow-up data, including recurrence, residual disease, lymph node metastasis, and survival status, were obtained from clinical records. Results Patient and Lesion Characteristics: Seventeen early GI cancers were identified during the study period. The mean patient age was 76 years, with a male predominance (M:F, 2.4:1). Lesions involved the esophagus, stomach, sigmoid colon, and rectum, and histologic subtypes included esophagal squamous cell carcinoma, Barrett ‘s-associated esophagal adenocarcinoma, gastric adenocarcinoma, and colorectal adenocarcinoma. Endoscopic Outcomes: En bloc resection was achieved in 88% of malignant cases. Two specimens were considered indeterminate due to fragmentation or technical limitations affecting margin assessment. Pathological Classification of Entire Cohort: Pathological classification of all ESD resections in the study cohort is summarised in Table 1 . Of the 17 early gastrointestinal cancers treated by ESD, nine resections met guideline-defined criteria for curative ESD, five were classified as non-curative based on the presence of high-risk pathological features, and two cases were considered indeterminate due to limitations in margin or risk assessment. Indeterminate resections were analysed separately and were not included in calculations of curative resections. Validation of Guideline -Standard Curative Criteria ( Curative Versus Non-Curative ESD): Clinical outcomes after application of standard guideline-defined curative and non-curative ESD criteria in evaluable cases are shown in Table 2 . After exclusion of the two indeterminate resections, 15 cases were considered evaluable for outcome analysis. Curative ESD was achieved in 9 of 15 cases (60%), all of whom remained disease-free during follow-up without the need for additional therapy. Non-curative or outcome-equivalent ESD was observed in 6 of 15 evaluable cases. This group included five cases with clearly defined non-curative pathological features and one initially indeterminate case that subsequently required oncologic surgery and was found to have lymph node metastasis. For outcome analysis, this case was appropriately grouped with non-curative ESD, accounting for the difference in non-curative case numbers between Table 1 and Table 2 . Figure 1 illustrates a representative case demonstrating endoscopic features, post-ESD defect, and corresponding histopathology leading to classification as non-curative ESD. Additional Therapy and Oncologic Outcomes: Additional surgery or locoregional therapy was undertaken in 29.4% (5/17) of patients. Residual tumour was identified in 3 patients undergoing surgery. Lymph node metastasis was detected in one patient despite the absence of a residual primary tumour. Discussion This real-world analysis from a tertiary referral centre in India, demonstrates that standard guideline-defined curative and non-curative ESD criteria reliably predict clinical outcomes when applied in routine practice outside structured high-volume expert centres. Patients identified as having curative ESD based on standard (JGES and ESGE) criteria experienced excellent oncologic outcomes without additional therapy, reinforcing the safety of endoscopic management when recommended resection pathological criteria are met [ 8 , 12 ]. In contrast, specimens with non-curative histopathological findings accurately identified patients who benefited from escalation of treatment beyond ESD. Detection of lymph node metastasis and residual tumour in this non-curative ESD cohort underscores the limitations of margin status alone and highlights the importance of comprehensive histopathological risk stratification following ESD [ 13 ]. These observations also support the view that non-curative ESD also serves as a diagnostic and staging step that enables timely and appropriate oncologic intervention and should not be considered as a mere procedural failure [ 14 ]. It is also worthwhile to note that site-specific risk assessment involves different clinical and histopathological criteria. In our cohort, upper GI lesions accounted for a larger and disproportionate share of non-curative resections. This is in concordance with previously recognised anatomical and technical challenges in achieving adequate vertical ESD resection margins in the esophagus and stomach. In colorectal cancers, in cases with apparent complete local resection, certain adverse histopathological features like tumour budding and lymphovascular invasion prompted additional surgery as recommended by standard guidelines [ 15 ]. Most published ESD outcome data originate from expert East Asian and Western centres and only a few studies have evaluated the performance of standard curative criteria in routine clinical settings in centres with evolving ESD expertise. In India, early GI cancers are often detected opportunistically outside structured screening programs, and lesions may present with greater biological heterogeneity [ 5 , 8 ]. Our findings demonstrate broader generalizability of existing guideline-based decision frameworks remains, as they have shown robustness in the discussed context. The strengths of this study include comprehensive clinicopathologic correlation across multiple GI sites, detailed histopathological evaluation using standardised ICCR protocols and integration of multidisciplinary management. The study has limitations, including its usage of a single tertiary care centre, retrospective design, modest sample size, and variable follow-up duration. Nevertheless, the consistent correlation between clinical outcomes and post-ESD histopathological classification supports the validity of the conclusions and positions this study as affirmative real-world evidence [ 7 , 11 ]. Conclusions In this real-world Indian experience, application of standard international curative and non-curative ESD criteria accurately predicted clinical outcomes and guided post-resection management for early gastrointestinal cancers. These findings support the clinical applicability and generalisability of existing ESD decision frameworks in routine Indian practice and similar healthcare settings. Abbreviations ANED – Alive with no evidence of disease BE – Barrett’s esophagus CBD – Cannot be determined CIS – Carcinoma in situ CRC – Colorectal cancer DOI – Depth of invasion EC – Ethics Committee ESD – Endoscopic submucosal dissection ESGE – European Society of Gastrointestinal Endoscopy GI – Gastrointestinal H&E – Hematoxylin and eosin HM – Horizontal margin ICCR – International Collaboration on Cancer Reporting IPCLs – Intrapapillary capillary loops JES – Japan Esophageal Society JGES – Japan Gastroenterological Endoscopy Society LN – Lymph node LAR – Low anterior resection MDT – Multidisciplinary team NA – Not applicable NBI – Narrow band imaging pT – Pathological tumor stage Rx – Indeterminate resection SqCC – Squamous cell carcinoma TAMIS – Transanal minimally invasive surgery VM – Vertical margin Declarations Ethics approval and consent to participate: The study protocol was reviewed and approved by the institutional ethics committee of Sir Ganga Ram Hospital, New Delhi ( Reference number: EC/10/24/2603) Consent for publication : NA Availability of data : The datasets collected during the current study were collected as part of routine clinical care at Sir Ganga Ram Hospital. The data are not publicly available but are available from the corresponding author on reasonable request. Competing interests : No conflict of interests to declare Funding : NA Authors Contributions: Sr No Name Degree Contributions 1 * Shrihari Anil Anikhindi MD, DNB Conceptualization, Investigation, Supervision, Writing - original draft, Writing - review & editing. 2 Sunayana Misra MD Conceptualization, Investigation. 3 Noriya Uedo MD Validation. 4 Shivam Khare MD, DNB Conceptualization, Investigation. 5 Shashi Dhawan MD Validation, Investigation. 6 Aditya Kumar B.Tech Writing - review & editing, Data curation. 7 Seema Rao MD Investigation. 8 Praveen Sharma MD, DM Validation. 9 Ashish Kumar MD, DM Validation. 10 Naresh Bansal MD, DNB Validation. 11 Umang Arora MD, DM Validation. 12 Sonia Badwal MD Investigation. 13 Anil Arora MD, DM Conceptualization, Supervision, Validation. * Corresponding Author : Dr. Shrihari Anikhindi, Consultant Gastroenterologist, Department of Medical Gastroenterology, Institute of Liver Gastroenterology & Pancreatico Biliary Sciences, Sir Ganga Ram Hospital, New Delhi, email: [email protected] Acknowledgments The authors thank the nursing staff and technical personnel of the Endoscopy Unit and the Department of Pathology at Sir Ganga Ram Hospital, New Delhi, for their support during patient care, specimen processing, and data retrieval. The authors also acknowledge the contributions of the multidisciplinary team involved in the management of these patients Author Approval: This manuscript has been read and approved by all authors. All requirements for authorship have been met, and each author believes that the manuscript represents honest work. Informed Consent: Given the retrospective, observational nature of the study and use of anonymised clinical data, the requirement for informed consent was waived. Registry and the Registration No. of the study/trial: The study protocol was reviewed and approved by the institutional ethics committee of Sir Ganga Ram Hospital, New Delhi ( Reference number: EC/10/24/2603). Animal Studies: NA Ethical Statement This study was conducted in accordance with the Declaration of Helsinki. The study protocol was reviewed and approved by the institutional ethics committee of Sir Ganga Ram Hospital, New Delhi ( Reference number: EC/10/24/2603) . Given the retrospective, observational nature of the study and use of anonymised clinical data, the requirement for informed consent was waived. References Gotoda T, Yamamoto H, Roy M. Soetikno. Endoscopic submucosal dissection of early gastric cancer. J Gastroenterol. 2006;41(10):929–42. https://doi.org/10.1007/s00535-006-1954-3 . Ono H, Yao K, Fujishiro M, Oda I, Uedo N, Nimura S, Yahagi N, et al. Guidelines for endoscopic submucosal dissection and endoscopic mucosal resection for early gastric cancer. Dig Endoscopy. 2021;33(1):4–20. https://doi.org/10.1111/den.13883 . Zullo A, Manta R, Francesco VD, Manfredi G, Buscarini E, Fiorini G, Vaira D, Marmo R. Endoscopic submucosal dissection of gastric neoplastic lesions in Western countries: systematic review and meta-analysis. Eur J Gastroenterol Hepatol. 2021;33(11):e1–6. https://doi.org/10.1097/MEG.0000000000001886 . Probst, Andreas D, Golger M, Anthuber B, Märkl, Helmut Messmann. 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Clinical outcomes of non-curative endoscopic submucosal dissection with negative resected margins for gastric cancer. Gastrointestinal endoscopy 85, 6 (2017): 1218–24. https://doi.org/10.1016/j.gie.2016.11.018 Hashiguchi Y, Muro K, Saito Y, Ito Y, Ajioka Y, Hamaguchi T, Hasegawa K, et al. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer. Int J Clin Oncol. 2020;25(1):1–42. https://doi.org/10.1007/s10147-019-01485-z . Tables Table 1 and 2 are available in the Supplementary Files section. Additional Declarations No competing interests reported. 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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-8568642","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":617990983,"identity":"ab9c4b9e-041d-4b4f-9b82-12e9ddc143b1","order_by":0,"name":"Shrihari Anil 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13:53:17","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-8568642/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-8568642/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":106725806,"identity":"c99e1830-cf69-48d0-84b9-8e453c5ce9b6","added_by":"auto","created_at":"2026-04-12 18:33:56","extension":"jpeg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":631874,"visible":true,"origin":"","legend":"\u003cp\u003ea. Endoscopic image with NBI (Non-Magnified) showing a demarcated, brownish area (representing dilated IPCLs) suspicious for neoplasm in the mid esophagus.\u003c/p\u003e\n\u003cp\u003eb. Endoscopic image with Magnification NBI showing JES Type B1 vessels suggestive of early squamous cell carcinoma.\u003c/p\u003e\n\u003cp\u003ec. Endoscopic image with Lugol’s Iodine Chromoendoscopy shows the well-demarcated primary lesion and a smaller secondary lesion, both show Lugol’s voiding areas with the classical “pink-color sign”\u003c/p\u003e\n\u003cp\u003ed. Resection of the neoplasm with ESD technique. A thin rim of remnant normal mucosa after a near-circumferential ESD can be seen.\u003c/p\u003e\n\u003cp\u003ee/f. Carcinoma in situ predominantly involving muscularis mucosa(m3 level), but also focally involving esophageal submucosal ducts and cancerization of adjacent submucosal glands arranged in a lobular pattern at the resection margin (H\u0026amp;E, original magnifications 40× and 100×).\u003c/p\u003e\n\u003cp\u003eAbbreviations\u003c/p\u003e\n\u003cp\u003eNBI – Narrow Band Imaging\u003c/p\u003e\n\u003cp\u003eJES – Japan Esophageal Society\u003c/p\u003e\n\u003cp\u003eESD – Endoscopic Submucosal Dissection\u003c/p\u003e\n\u003cp\u003eH\u0026amp;E - Hematoxylin and Eosin\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-8568642/v1/736461fb526d93f2af2bd94b.jpeg"},{"id":106727217,"identity":"b05967a7-1a3c-48d6-9027-746eb73c951f","added_by":"auto","created_at":"2026-04-12 18:38:20","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1378592,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-8568642/v1/0b20c276-4df7-40ad-8ccc-a948dd000a92.pdf"},{"id":106534838,"identity":"3aafe65f-dee4-452a-8931-0b043b3c4488","added_by":"auto","created_at":"2026-04-09 15:06:47","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":21888,"visible":true,"origin":"","legend":"","description":"","filename":"Tables12.docx","url":"https://assets-eu.researchsquare.com/files/rs-8568642/v1/4147f7e956229dadb52a4f41.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Real-World Validation of Guideline-Defined Curative Criteria After Endoscopic Submucosal Dissection for Early Gastrointestinal Cancers: An Indian Experience","fulltext":[{"header":"Introduction","content":"\u003cp\u003eEarly gastrointestinal (GI) cancers are increasingly detected at an early stage due to advances in imaging, effective screening strategies, and heightened clinical awareness. This has also advanced the field of endoscopic resections. Endoscopic submucosal dissection (ESD) is an effective technique for managing selected early GI cancers, enabling en bloc resection of lesions and often serving as a viable alternative to surgery [1,2]. Compared with piecemeal resections, ESD facilitates accurate assessment of resection margins, depth of invasion, and other adverse histological features, which are critical determinants of oncologic risk.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eExisting data and experience, predominantly from expert centres in East Asia and increasingly from the West, have shown that ESD offers oncologic outcomes comparable to surgical resection for appropriately selected lesions while preserving organ function and reducing morbidity [3]. Thus, ESD is incorporated into most management algorithms for early cancers of the oesophagus, stomach, and colon worldwide [4,5].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe true clinical value of ESD lies not only in en bloc resection but also in its ability to provide definitive pathological assessment and risk stratification that guide subsequent management [6]. Contemporary international guidelines, including those from the Japan Gastroenterological Endoscopy Society (JGES) and the European Society of Gastrointestinal Endoscopy (ESGE), have defined standard pathological criteria to classify ESD as curative or non-curative based on features such as margin status, depth of submucosal invasion, lymphovascular invasion, tumor differentiation, and tumor budding [2,7,8]. This classification is pivotal for deciding the post-ESD management paradigm, including the need for additional surgery or locoregional therapy.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eMajority of outcome data supporting these criteria originates from high-volume expert centres operating within structured population-based screening programs. Utility of these guidelines in routine real-world practice in countries like India, with differing screening strategies, disease presentation, and healthcare pathways, is underexplored [5,7]. To confirm the generalizability and clinical validity of existing ESD decision frameworks, it is essential to evaluate outcomes in this context. The present study was therefore undertaken to evaluate the real-world clinical validity of standard guideline-defined curative criteria following ESD for early GI cancers in a tertiary-care center in India.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBackground\u003c/p\u003e\n\u003cp\u003eEarly gastrointestinal cancers can often be cured with organ-preserving endoscopic therapy when detected at an early stage. Endoscopic submucosal dissection enables en bloc resection and provides detailed pathological assessment, which is central to post-resection risk stratification. International guidelines from the European Society of Gastrointestinal Endoscopy and the Japan Gastroenterological Endoscopy Society define standardized criteria to classify ESD as curative or non-curative and guide decisions regarding surveillance or additional oncologic treatment [2,7]. However, these criteria are primarily derived from high-volume expert centres within structured screening programs, and their performance in routine clinical practice remains less well established [5]. In countries such as India, where early GI cancers are detected opportunistically and ESD programs are still evolving, the real-world applicability of these guidelines is uncertain. This study therefore aimed to validate guideline-defined curative and non-curative ESD criteria in an Indian tertiary-care setting by correlating standardized pathological classification with clinical outcomes, providing pragmatic evidence for their use in routine practice.\u003c/p\u003e"},{"header":"Methods","content":"\u003ch3\u003eStudy Design and Patient Selection:\u003c/h3\u003e\u003cp\u003eThis retrospective observational study was conducted at a tertiary-care referral centre in India. All consecutive patients with histologically confirmed early epithelial gastrointestinal (GI) cancers (pathological stage pTis–pT1) who underwent ESD as primary therapy from January 2020 to December 2024 were eligible for inclusion. Lesions involving the esophagus, stomach, and colorectum were included. Patients undergoing endoscopic mucosal resection, polypectomy, or surgical resection as initial therapy were excluded, as were benign lesions and subepithelial tumors. The analysis was designed as a real-world, hypothesis-generating validation study, focusing on the clinical performance of guideline-defined curative and non-curative criteria following endoscopic submucosal dissection (ESD), rather than on comparative efficacy or volume-based outcomes. All patients underwent ESD as primary therapy without neoadjuvant treatment.\u003c/p\u003e\u003ch2\u003eEndoscopic Technique:\u003c/h2\u003e\u003cp\u003eESD procedures were performed by experienced endoscopists using standard techniques and electrosurgical knives. Lesions were carefully delineated using high-definition white light endoscopy and image-enhanced modalities. The procedural goal was en bloc resection with adequate lateral and vertical margins.\u003c/p\u003e\u003ch3\u003ePathological Processing and Evaluation:\u003c/h3\u003e\u003cp\u003eAll specimens were handled using standardised grossing protocols by experienced GI histopathologists. Resected specimens were pinned mucosal-side up to prevent curling, fixed in formalin, inked at resection margins, and serially sectioned at 2–3 mm intervals. Histopathological evaluation was performed using standardised ICCR datasets specific to esophageal, gastric, and colorectal endoscopic resection specimens [\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e]. Parameters assessed included histologic subtype and grade, depth of invasion using site-specific microstaging systems, horizontal and vertical margin status, lymphovascular invasion, perineural invasion, and tumour budding in colorectal cancers [\u003cspan class=\"CitationRef\"\u003e10\u003c/span\u003e]. Ancillary immunohistochemical stains were employed when required.\u003c/p\u003e\u003ch3\u003eDefinitions and Follow-Up:\u003c/h3\u003e\u003cp\u003eCurative and non-curative ESD were defined in accordance with ESGE and JGES criteria [\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e11\u003c/span\u003e]. Patients were discussed in multidisciplinary team meetings, and recommendations for additional therapy were individualised based on pathological risk stratification. Follow-up data, including recurrence, residual disease, lymph node metastasis, and survival status, were obtained from clinical records.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cstrong\u003ePatient and Lesion Characteristics:\u003c/strong\u003e\u003cbr\u003e\u0026nbsp; Seventeen early GI cancers were identified during the study period. The mean patient age was 76 years, with a male predominance (M:F, 2.4:1). Lesions involved the esophagus, stomach, sigmoid colon, and rectum, and histologic subtypes included esophagal squamous cell carcinoma, Barrett \u0026lsquo;s-associated esophagal adenocarcinoma, gastric adenocarcinoma, and colorectal adenocarcinoma.\u003cbr\u003e\u003cstrong\u003eEndoscopic Outcomes:\u003c/strong\u003e\u003cbr\u003e\u0026nbsp; En bloc resection was achieved in 88% of malignant cases. Two specimens were considered indeterminate due to fragmentation or technical limitations affecting margin assessment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePathological Classification of Entire Cohort:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003ePathological classification of all ESD resections in the study cohort is summarised in \u003cstrong\u003eTable 1\u003c/strong\u003e. Of the 17 early gastrointestinal cancers treated by ESD, nine resections met guideline-defined criteria for curative ESD, five were classified as non-curative based on the presence of high-risk pathological features, and two cases were considered indeterminate due to limitations in margin or risk assessment. Indeterminate resections were analysed separately and were not included in calculations of curative resections.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eValidation of Guideline\u003cstrong\u003e-Standard Curative Criteria (\u003c/strong\u003eCurative Versus Non-Curative ESD):\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eClinical outcomes after application of standard guideline-defined curative and non-curative ESD criteria in evaluable cases are shown in \u003cstrong\u003eTable 2\u003c/strong\u003e. After exclusion of the two indeterminate resections, 15 cases were considered evaluable for outcome analysis. Curative ESD was achieved in 9 of 15 cases (60%), all of whom remained disease-free during follow-up without the need for additional therapy.\u003c/p\u003e\n\u003cp\u003eNon-curative or outcome-equivalent ESD was observed in 6 of 15 evaluable cases. This group included five cases with clearly defined non-curative pathological features and one initially indeterminate case that subsequently required oncologic surgery and was found to have lymph node metastasis. For outcome analysis, this case was appropriately grouped with non-curative ESD, accounting for the difference in non-curative case numbers between \u003cstrong\u003eTable 1\u003c/strong\u003e and \u003cstrong\u003eTable 2\u003c/strong\u003e.\u0026nbsp;\u003cstrong\u003eFigure 1\u003c/strong\u003e illustrates a representative case demonstrating endoscopic features, post-ESD defect, and corresponding histopathology leading to classification as non-curative ESD.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdditional Therapy and Oncologic Outcomes:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAdditional surgery or locoregional therapy was undertaken in 29.4% (5/17) of patients. Residual tumour was identified in 3 patients undergoing surgery. Lymph node metastasis was detected in one patient despite the absence of a residual primary tumour.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003e This real-world analysis from a tertiary referral centre in India, demonstrates that standard guideline-defined curative and non-curative ESD criteria reliably predict clinical outcomes when applied in routine practice outside structured high-volume expert centres. Patients identified as having curative ESD based on standard (JGES and ESGE) criteria experienced excellent oncologic outcomes without additional therapy, reinforcing the safety of endoscopic management when recommended resection pathological criteria are met [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIn contrast, specimens with non-curative histopathological findings accurately identified patients who benefited from escalation of treatment beyond ESD. Detection of lymph node metastasis and residual tumour in this non-curative ESD cohort underscores the limitations of margin status alone and highlights the importance of comprehensive histopathological risk stratification following ESD [\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]. These observations also support the view that non-curative ESD also serves as a diagnostic and staging step that enables timely and appropriate oncologic intervention and should not be considered as a mere procedural failure [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eIt is also worthwhile to note that site-specific risk assessment involves different clinical and histopathological criteria. In our cohort, upper GI lesions accounted for a larger and disproportionate share of non-curative resections. This is in concordance with previously recognised anatomical and technical challenges in achieving adequate vertical ESD resection margins in the esophagus and stomach. In colorectal cancers, in cases with apparent complete local resection, certain adverse histopathological features like tumour budding and lymphovascular invasion prompted additional surgery as recommended by standard guidelines [\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eMost published ESD outcome data originate from expert East Asian and Western centres and only a few studies have evaluated the performance of standard curative criteria in routine clinical settings in centres with evolving ESD expertise. In India, early GI cancers are often detected opportunistically outside structured screening programs, and lesions may present with greater biological heterogeneity [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e, \u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Our findings demonstrate broader generalizability of existing guideline-based decision frameworks remains, as they have shown robustness in the discussed context.\u003c/p\u003e \u003cp\u003eThe strengths of this study include comprehensive clinicopathologic correlation across multiple GI sites, detailed histopathological evaluation using standardised ICCR protocols and integration of multidisciplinary management. The study has limitations, including its usage of a single tertiary care centre, retrospective design, modest sample size, and variable follow-up duration. Nevertheless, the consistent correlation between clinical outcomes and post-ESD histopathological classification supports the validity of the conclusions and positions this study as affirmative real-world evidence [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e, \u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e"},{"header":"Conclusions","content":"\u003cp\u003eIn this real-world Indian experience, application of standard international curative and non-curative ESD criteria accurately predicted clinical outcomes and guided post-resection management for early gastrointestinal cancers. These findings support the clinical applicability and generalisability of existing ESD decision frameworks in routine Indian practice and similar healthcare settings.\u003c/p\u003e "},{"header":"Abbreviations","content":"\u003cp\u003e\u003cstrong\u003eANED\u003c/strong\u003e \u0026ndash; Alive with no evidence of disease\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBE\u003c/strong\u003e \u0026ndash; Barrett\u0026rsquo;s esophagus\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCBD\u003c/strong\u003e \u0026ndash; Cannot be determined\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCIS\u003c/strong\u003e \u0026ndash; Carcinoma in situ\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCRC\u003c/strong\u003e \u0026ndash; Colorectal cancer\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDOI\u003c/strong\u003e \u0026ndash; Depth of invasion\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEC\u003c/strong\u003e \u0026ndash; Ethics Committee\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eESD\u003c/strong\u003e \u0026ndash; Endoscopic submucosal dissection\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eESGE\u003c/strong\u003e \u0026ndash; European Society of Gastrointestinal Endoscopy\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eGI\u003c/strong\u003e \u0026ndash; Gastrointestinal\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eH\u0026amp;E\u003c/strong\u003e \u0026ndash; Hematoxylin and eosin\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHM\u003c/strong\u003e \u0026ndash; Horizontal margin\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eICCR\u003c/strong\u003e \u0026ndash; International Collaboration on Cancer Reporting\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIPCLs\u003c/strong\u003e \u0026ndash; Intrapapillary capillary loops\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eJES\u003c/strong\u003e \u0026ndash; Japan Esophageal Society\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eJGES\u003c/strong\u003e \u0026ndash; Japan Gastroenterological Endoscopy Society\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eLN\u003c/strong\u003e \u0026ndash; Lymph node\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eLAR\u003c/strong\u003e \u0026ndash; Low anterior resection\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMDT\u003c/strong\u003e \u0026ndash; Multidisciplinary team\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eNA\u003c/strong\u003e \u0026ndash; Not applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eNBI\u003c/strong\u003e \u0026ndash; Narrow band imaging\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003epT\u003c/strong\u003e \u0026ndash; Pathological tumor stage\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRx\u003c/strong\u003e \u0026ndash; Indeterminate resection\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSqCC\u003c/strong\u003e \u0026ndash; Squamous cell carcinoma\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTAMIS\u003c/strong\u003e \u0026ndash; Transanal minimally invasive surgery\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eVM\u003c/strong\u003e \u0026ndash; Vertical margin\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eEthics approval and consent to participate:\u0026nbsp;The study protocol was reviewed and approved by the institutional ethics committee of Sir Ganga Ram Hospital, New Delhi ( Reference number: EC/10/24/2603)\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e: NA\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data\u003c/strong\u003e:\u0026nbsp;The datasets collected during the current study were collected as part of routine clinical care at Sir Ganga Ram Hospital. The data are not publicly available but are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e:\u0026nbsp;No conflict of interests to declare\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e: NA\u003c/p\u003e\n\u003cp\u003eAuthors Contributions:\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003eSr No\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003eName\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 128px;\"\u003e\n \u003cp\u003eDegree\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 321px;\"\u003e\n \u003cp\u003eContributions\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e1\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003eShrihari Anil Anikhindi\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 128px;\"\u003e\n \u003cp\u003eMD, DNB\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 321px;\"\u003e\n \u003cp\u003eConceptualization, Investigation, Supervision, Writing - original draft, Writing - review \u0026amp; editing.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003eSunayana Misra\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 128px;\"\u003e\n \u003cp\u003eMD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 321px;\"\u003e\n \u003cp\u003eConceptualization, Investigation.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003eNoriya Uedo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 128px;\"\u003e\n \u003cp\u003eMD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 321px;\"\u003e\n \u003cp\u003eValidation.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003eShivam Khare\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 128px;\"\u003e\n \u003cp\u003eMD, DNB\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 321px;\"\u003e\n \u003cp\u003eConceptualization, Investigation.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003eShashi Dhawan\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 128px;\"\u003e\n \u003cp\u003eMD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 321px;\"\u003e\n \u003cp\u003eValidation, Investigation.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003eAditya Kumar\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 128px;\"\u003e\n \u003cp\u003eB.Tech\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 321px;\"\u003e\n \u003cp\u003eWriting - review \u0026amp; editing, Data curation.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003eSeema Rao\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 128px;\"\u003e\n \u003cp\u003eMD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 321px;\"\u003e\n \u003cp\u003eInvestigation.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003ePraveen Sharma\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 128px;\"\u003e\n \u003cp\u003eMD, DM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 321px;\"\u003e\n \u003cp\u003eValidation.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003eAshish Kumar\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 128px;\"\u003e\n \u003cp\u003eMD, DM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 321px;\"\u003e\n \u003cp\u003eValidation.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003eNaresh Bansal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 128px;\"\u003e\n \u003cp\u003eMD, DNB\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 321px;\"\u003e\n \u003cp\u003eValidation.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e11\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003eUmang Arora\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 128px;\"\u003e\n \u003cp\u003eMD, DM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 321px;\"\u003e\n \u003cp\u003eValidation.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e12\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003eSonia Badwal\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 128px;\"\u003e\n \u003cp\u003eMD\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 321px;\"\u003e\n \u003cp\u003eInvestigation.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 113px;\"\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 136px;\"\u003e\n \u003cp\u003eAnil Arora\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 128px;\"\u003e\n \u003cp\u003eMD, DM\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 321px;\"\u003e\n \u003cp\u003eConceptualization, Supervision, Validation.\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003e\u003csup\u003e\u0026nbsp;\u003c/sup\u003e\u003c/strong\u003e\u003cstrong\u003e\u003csup\u003e*\u003c/sup\u003e\u003c/strong\u003e\u003cstrong\u003eCorresponding Author\u003c/strong\u003e: Dr. Shrihari Anikhindi, Consultant Gastroenterologist, Department of Medical Gastroenterology, Institute of Liver Gastroenterology \u0026amp; Pancreatico Biliary Sciences, Sir Ganga Ram Hospital, New Delhi, email: [email protected]\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors thank the nursing staff and technical personnel of the Endoscopy Unit and the Department of Pathology at Sir Ganga Ram Hospital, New Delhi, for their support during patient care, specimen processing, and data retrieval. The authors also acknowledge the contributions of the multidisciplinary team involved in the management of these patients\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor Approval:\u003c/strong\u003e This manuscript has been read and approved by all authors. All requirements for authorship have been met, and each author believes that the manuscript represents honest work.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;Informed Consent:\u0026nbsp;\u003c/strong\u003eGiven the retrospective, observational nature of the study and use of anonymised clinical data, the requirement for informed consent was waived.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRegistry and the Registration No. of the study/trial:\u0026nbsp;\u003c/strong\u003eThe study protocol was reviewed and approved by the institutional ethics committee of Sir Ganga Ram Hospital, New Delhi ( Reference number: EC/10/24/2603).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAnimal Studies:\u0026nbsp;\u003c/strong\u003eNA\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthical Statement\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was conducted in accordance with the Declaration of Helsinki. The study protocol was reviewed and approved by the institutional ethics committee of Sir Ganga Ram Hospital, New Delhi ( Reference number: EC/10/24/2603) . Given the retrospective, observational nature of the study and use of anonymised clinical data, the requirement for informed consent was waived.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eGotoda T, Yamamoto H, Roy M. Soetikno. Endoscopic submucosal dissection of early gastric cancer. J Gastroenterol. 2006;41(10):929\u0026ndash;42. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s00535-006-1954-3\u003c/span\u003e\u003cspan address=\"10.1007/s00535-006-1954-3\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eOno H, Yao K, Fujishiro M, Oda I, Uedo N, Nimura S, Yahagi N, et al. 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Risk factors of lymph node metastasis after non-curative endoscopic resection of undifferentiated-type early gastric cancer. Gastric Cancer. 2021;24:1. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s10120-020-01103-2\u003c/span\u003e\u003cspan address=\"10.1007/s10120-020-01103-2\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eToya Y, Endo M, Nakamura S, Akasaka R, Kosaka T, Yanai S, Kawasaki K, Koeda K. Tamotsu Sugai, and Takayuki Matsumoto. Clinical outcomes of non-curative endoscopic submucosal dissection with negative resected margins for gastric cancer. Gastrointestinal endoscopy 85, 6 (2017): 1218\u0026ndash;24. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1016/j.gie.2016.11.018\u003c/span\u003e\u003cspan address=\"10.1016/j.gie.2016.11.018\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHashiguchi Y, Muro K, Saito Y, Ito Y, Ajioka Y, Hamaguchi T, Hasegawa K, et al. Japanese Society for Cancer of the Colon and Rectum (JSCCR) guidelines 2019 for the treatment of colorectal cancer. Int J Clin Oncol. 2020;25(1):1\u0026ndash;42. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1007/s10147-019-01485-z\u003c/span\u003e\u003cspan address=\"10.1007/s10147-019-01485-z\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003eTable 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":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-gastroenterology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmge","sideBox":"Learn more about [BMC Gastroenterology](http://bmcgastroenterol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bmge/default.aspx","title":"BMC Gastroenterology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Curative ESD, Endoscopic Submucosal Dissection, Early Gastrointestinal Cancer, Non-Curative ESD, Pathology","lastPublishedDoi":"10.21203/rs.3.rs-8568642/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-8568642/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eAims and Background:\u003c/h2\u003e \u003cp\u003eEndoscopic submucosal dissection (ESD) is an effective alternative to surgery for early gastrointestinal (GI) cancers. Curative and non-curative ESD criteria are primarily derived from high-volume centres within structured screening programs, where pathological assessment guides post-resection management. However, real-world validation of these criteria in routine clinical practice, particularly in centres with evolving ESD expertise, remains limited. We evaluated outcomes of ESD-treated early GI cancers using standard guideline-defined curative criteria in a tertiary-care centre in India.\u003c/p\u003e\u003ch2\u003eMethods:\u003c/h2\u003e \u003cp\u003eThis retrospective descriptive study included patients with early epithelial GI cancers (pTis\u0026ndash;pT1) treated by ESD a tertiary care centre. Resected specimens were processed using International Collaboration on Cancer Reporting datasets and classified as curative or non-curative according to European Society of Gastrointestinal Endoscopy and Japan Gastroenterological Endoscopy Society criteria. Clinical outcomes, additional therapy, follow-up status analysed.\u003c/p\u003e\u003ch2\u003eResults:\u003c/h2\u003e \u003cp\u003eSeventeen early GI cancers underwent ESD, with en-bloc resection achieved in 88%. After excluding two indeterminate resections, curative ESD was achieved in 60% (9/15). Median follow-up was 18 months (range 6\u0026ndash;36 months). All patients with curative ESD remained disease-free without additional therapy. Non-curative ESD occurred in 40% (6/15), leading to additional surgery or locoregional therapy in 29% (5/17). Residual tumour was identified in three patients, and lymph node metastasis was detected in one patient despite absence of residual primary tumour.\u003c/p\u003e\u003ch2\u003eConclusions:\u003c/h2\u003e \u003cp\u003e Application of standard guideline-based curative criteria in routine Indian clinical practice reliably predicted outcomes and guided post-resection management, supporting the generalizability of established ESD decision frameworks beyond expert screening-based settings.\u003c/p\u003e","manuscriptTitle":"Real-World Validation of Guideline-Defined Curative Criteria After Endoscopic Submucosal Dissection for Early Gastrointestinal Cancers: An Indian Experience","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-04-09 15:06:27","doi":"10.21203/rs.3.rs-8568642/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2026-04-18T23:58:50+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2026-04-15T00:28:24+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"8396987874531521707829926914698710945","date":"2026-04-09T23:43:56+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"80750977017682790909547355860226057229","date":"2026-04-09T09:51:05+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-04-02T15:26:21+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2026-03-10T09:49:13+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-01-13T04:54:56+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-01-13T04:53:06+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Gastroenterology","date":"2026-01-10T13:45:38+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-gastroenterology","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmge","sideBox":"Learn more about [BMC Gastroenterology](http://bmcgastroenterol.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/bmge/default.aspx","title":"BMC Gastroenterology","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"00004e3e-e44f-40a7-a68c-f466b2de815a","owner":[],"postedDate":"April 9th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-04-09T15:06:28+00:00","versionOfRecord":[],"versionCreatedAt":"2026-04-09 15:06:27","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-8568642","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-8568642","identity":"rs-8568642","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}