Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-29 @ 7:08 AM
Study NCT ID:
NCT06060106
Status:
COMPLETED
Last Update Posted:
2023-09-29
First Post:
2023-06-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069916', 'term': 'Endoscopic Mucosal Resection'}, {'id': 'D016629', 'term': 'Esophagectomy'}], 'ancestors': [{'id': 'D016099', 'term': 'Endoscopy, Gastrointestinal'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 191}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-27', 'studyFirstSubmitDate': '2023-06-15', 'studyFirstSubmitQcDate': '2023-09-27', 'lastUpdatePostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'overall survival (OS)', 'timeFrame': '10 years', 'description': 'OS was measured from the date of ESD or esophagectomy until death from any cause'}, {'measure': 'Disease specific survival (DSS)', 'timeFrame': '10 years', 'description': 'DSS was measured from the date of ESD or esophagectomy until death resulting from ESCC'}, {'measure': 'Recurrence free survival (RFS)', 'timeFrame': '10 years', 'description': 'RFS was measured from the date of ESD or esophagectomy until the first recurrence or metastasis'}], 'secondaryOutcomes': [{'measure': 'postoperative complications', 'timeFrame': '30 days', 'description': 'Major postoperative complications includes bleeding, infection, and perforation，stricture and anastomotic leakage, adverse events assessed by blood tests, imageological examination and Endoscopic evaluation. Complications were graded according to the Clavien-Dindo classification system. The higher the complication grade, the more serious.'}, {'measure': 'R0 resection', 'timeFrame': '15 days', 'description': 'R0 resection was defined as horizontal and vertical margins free from both cancerous and precancerous tissues (HGIN), and without evidence of LVI. Pathological assessment was performed independently by two pathologists.'}, {'measure': 'adjuvant therapy', 'timeFrame': '10 years', 'description': 'During follow-up, record whether Adjuvant therapy (i.e., additional endoscopy/surgery, radiotherapy and/or chemotherapy) was administered.'}, {'measure': 'operation time', 'timeFrame': '12 hours', 'description': 'Time from start to finish of operation, measured in minutes'}, {'measure': 'Post-operative hospitalization days', 'timeFrame': '30 days', 'description': 'Date of discharge minus date of operation,measured in days'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esophageal Cancer']}, 'referencesModule': {'references': [{'pmid': '29704682', 'type': 'BACKGROUND', 'citation': 'Zhang Y, Ding H, Chen T, Zhang X, Chen WF, Li Q, Yao L, Korrapati P, Jin XJ, Zhang YX, Xu MD, Zhou PH. Outcomes of Endoscopic Submucosal Dissection vs Esophagectomy for T1 Esophageal Squamous Cell Carcinoma in a Real-World Cohort. Clin Gastroenterol Hepatol. 2019 Jan;17(1):73-81.e3. doi: 10.1016/j.cgh.2018.04.038. Epub 2018 Apr 25.'}, {'pmid': '33042630', 'type': 'BACKGROUND', 'citation': 'An W, Liu MY, Zhang J, Cui YP, Gao J, Wang LP, Chen Y, Yang LX, Chen HZ, Jin H, Liu F, Chen J, Li ZS, Wang LW, Shi XG, Sun C. Endoscopic submucosal dissection versus esophagectomy for early esophageal squamous cell carcinoma with tumor invasion to different depths. Am J Cancer Res. 2020 Sep 1;10(9):2977-2992. eCollection 2020.'}, {'pmid': '35530330', 'type': 'BACKGROUND', 'citation': 'Liu Z, Zhao R. Endoscopic Submucosal Dissection vs. Surgery for Superficial Esophageal Squamous Cancer: A Systematic Review and Meta-Analysis. Front Oncol. 2022 Apr 21;12:816832. doi: 10.3389/fonc.2022.816832. eCollection 2022.'}, {'pmid': '36458047', 'type': 'BACKGROUND', 'citation': 'Qian M, Feng S, Zhou H, Chen L, Wang S, Zhang K. Endoscopic submucosal dissection versus esophagectomy for t1 esophageal squamous cell carcinoma: a propensity score-matched analysis. Therap Adv Gastroenterol. 2022 Nov 21;15:17562848221138156. doi: 10.1177/17562848221138156. eCollection 2022.'}]}, 'descriptionModule': {'briefSummary': 'Endoscopic submucosal dissection (ESD) is a minimally invasive alternative to esophagectomy for early esophageal squamous cell carcinoma (EESCC), The data of EESCC patients who received ESD or esophagectomy were retrospectively analyzed,The aim of this study was to compare the efficacy and safety of ESD and esophagectomy in EESCC,Risk factors affecting the prognosis of patients with early esophageal squamous cell carcinoma were analyzed.', 'detailedDescription': 'Endoscopic submucosal dissection (ESD) is a minimally invasive alternative to esophagectomy for early esophageal squamous cell carcinoma (EESCC).The aim of this study was to compare the efficacy and safety of ESD and esophagectomy in EESCC，The data of EESCC patients who received ESD or esophagectomy were retrospectively analyzed. Overall survival (OS), disease specific survival (DSS), recurrence free survival (RFS), and procedure-related variables were compared between ESD and esophagectomy patients.Risk factors affecting the prognosis of patients with early esophageal squamous cell carcinoma were analyzed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with early esophageal cancer from January 2011 to January 2021 admitted to Changhai Hospital were included in this study.Patients treated with ESD were classified as the ESD group, and those who underwent radical esophageal cancer treatment were classified as the surgical group.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Mucosal or submucosal squamous cell carcinoma of the esophagus\n2. no lymph node involvement or distant metastasis on computed tomography (CT) or pathology;\n\nExclusion Criteria:\n\n1. Tis premalignant lesions (high-grade intraepithelial neoplasia;HGIN)\n2. patients with neoadjuvant therapy\n3. patients combined with severe diseases of other organs'}, 'identificationModule': {'nctId': 'NCT06060106', 'briefTitle': 'Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Changhai Hospital'}, 'officialTitle': 'Endoscopic Submucosal Dissection Versus Esophagectomy for Early Esophageal Carcinoma：a Cohort Study', 'orgStudyIdInfo': {'id': 'early esophageal carcinoma'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endoscopic submucosal dissection', 'description': 'Early esophageal cancer patients treated with ESD', 'interventionNames': ['Procedure: Endoscopic submucosal dissection']}, {'label': 'Esophagectomy', 'description': 'Early esophageal cancer patients treated with esophagectomy', 'interventionNames': ['Procedure: Esophagectomy']}], 'interventions': [{'name': 'Endoscopic submucosal dissection', 'type': 'PROCEDURE', 'description': 'The patient was positioned in the left lateral decubitus position.Marking dots were made with a dual knife/hybrid knife around the lesion, and a solution of glycerin fructose with indigo carmine was injected into the submucosal layer to lift the lesion. Finally, after pre-cutting of the mucosal and submucosal layers around the lesion and dissection of the submucosa, the lesion was removed en bloc.', 'armGroupLabels': ['Endoscopic submucosal dissection']}, {'name': 'Esophagectomy', 'type': 'PROCEDURE', 'description': 'The main surgical methods of esophagectomy include the McKeown operation, Lvor-lewis, Sweet and minimally invasive radical resection of esophageal cancer (MIE)', 'armGroupLabels': ['Esophagectomy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'country': 'China', 'facility': 'Changhai Hospital, Naval Medical University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Wei An, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Changhai Hospital, Naval Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Changhai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of Gastroenterology，Changhai Hospital；Academician of Chinese Academy of Engineering', 'investigatorFullName': 'Zhaoshen Li', 'investigatorAffiliation': 'Changhai Hospital'}}}}