Ignite Creation Date:
2025-12-24 @ 7:40 PM
Ignite Modification Date:
2026-01-25 @ 3:44 AM
Study NCT ID:
NCT02306603
Status:
RECRUITING
Last Update Posted:
2025-03-27
First Post:
2014-12-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018253', 'term': 'Adenoma, Villous'}], 'ancestors': [{'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069916', 'term': 'Endoscopic Mucosal Resection'}], '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2027-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2014-12-01', 'studyFirstSubmitQcDate': '2014-12-02', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Observed procedural data: Number of Participants with Adverse Events as a Measure of Safety and Tolerability Outcomes', 'timeFrame': '14 days'}], 'secondaryOutcomes': [{'measure': 'Analysis of the costs of this procedure compared to previous treatments', 'timeFrame': '14 days', 'description': 'Perform cost-utility analyses comparing different treatment approaches for duodenal and ampullary lesions'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adenoma, Villous']}, 'referencesModule': {'references': [{'pmid': '37858758', 'type': 'DERIVED', 'citation': "Gupta S, Craciun A, Wang H, Whitfield A, Gauci J, O'Sullivan T, Cronin O, Abu Arisha M, Klein A, Lee EYT, Burgess NG, Bourke MJ. Hybrid resection versus conventional resection for laterally spreading lesions of the papilla. Gastrointest Endosc. 2024 Mar;99(3):428-436. doi: 10.1016/j.gie.2023.10.034. Epub 2023 Oct 17."}, {'pmid': '36720290', 'type': 'DERIVED', 'citation': "Wang H, Sidhu M, Gupta S, Cronin O, O'Sullivan T, Whitfield A, Burgess NG, Bourke MJ. Cold snare EMR for the removal of large duodenal adenomas. Gastrointest Endosc. 2023 Jun;97(6):1100-1108. doi: 10.1016/j.gie.2023.01.040. Epub 2023 Jan 28."}, {'pmid': '33285144', 'type': 'DERIVED', 'citation': 'Sidhu M, Fritzsche JA, Klein A, Shahidi N, Vosko S, van Hattem WA, Tate DJ, Bourke MJ. Outcomes of thermal ablation of the defect margin after duodenal endoscopic mucosal resection (with videos). Gastrointest Endosc. 2021 Jun;93(6):1373-1380. doi: 10.1016/j.gie.2020.11.024. Epub 2020 Dec 4.'}, {'pmid': '29768645', 'type': 'DERIVED', 'citation': 'Klein A, Qi Z, Bahin FF, Awadie H, Nayyar D, Ma M, Voermans RP, Williams SJ, Lee E, Bourke MJ. Outcomes after endoscopic resection of large laterally spreading lesions of the papilla and conventional ampullary adenomas are equivalent. Endoscopy. 2018 Oct;50(10):972-983. doi: 10.1055/a-0587-5228. Epub 2018 May 16.'}]}, 'descriptionModule': {'briefSummary': "This research project, 'Outcomes of endoscopic resection of mucosal and submucosal lesions in the duodenum and ampulla'. The research project is aiming to determine the most effective and safe way to remove such lesions.", 'detailedDescription': 'Endoscopic resection (ER) of superficial lesions of the duodenum and ampulla is a safe and effective surgery sparing modality in experienced hands. It is often curative of dysplastic lesions and is associated with minimal complications and high patient acceptance (1-5). Westmead Hospital has accumulated a significant amount of experience in the removal of such lesions; however, there is limited research to document the long term outcomes of patients undergoing endoscopic resection.The purpose of this study is to evaluate the long-term outcomes of ER of superficial lesions of the duodenum and ampulla.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who have Duodenal and ampullary adenomas which are amendable to Endoscopic Mucosal Resection', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\* Duodenal and ampullary lesion \\> 10mm\n\n* Lesion limited to the mucosal and/or submucosal layer (T1 lesion)\n* Aged 18 years or older\n\nExclusion Criteria:\n\n* Lesion less than 10mm\n* Duodenal or ampullary lesion involves the muscularis propria (T2 lesion) on other staging modalities such as endoscopic ultrasonography (EUS)\n* Aged younger than 18 years'}, 'identificationModule': {'nctId': 'NCT02306603', 'acronym': 'OERDA', 'briefTitle': 'Long-term Outcomes of Endoscopic Resection (ER) of Lesions of the Duodenum and Ampulla', 'organization': {'class': 'OTHER', 'fullName': 'Western Sydney Local Health District'}, 'officialTitle': 'Outcomes of Endoscopic Resection of Mucosal and Submucosal Lesions in the Duodenum and Ampulla', 'orgStudyIdInfo': {'id': 'HREC 2014/5/4.3 (3972)'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Endoscopic Mucosal Resection', 'description': 'Patients who are referred for Endoscopic Mucosal Resection of Duodenal and Ampullary Lesions will be included in this cohort.', 'interventionNames': ['Procedure: Endoscopic Mucosal Resection']}], 'interventions': [{'name': 'Endoscopic Mucosal Resection', 'type': 'PROCEDURE', 'armGroupLabels': ['Endoscopic Mucosal Resection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2145', 'city': 'Sydney', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Clarence Kerrison, MBBS', 'role': 'CONTACT', 'email': 'clarence.kerrison@health.nsw.gov.au', 'phone': '88905555'}, {'name': 'Michael J Bourke, MBBS', 'role': 'CONTACT', 'email': 'westmeadendoscopyresearch@gmail.com'}], 'facility': 'Westmead Hospital Endoscopy Unit', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}], 'centralContacts': [{'name': 'Michael Bourke, MBBS', 'role': 'CONTACT', 'email': 'michael@citywestgastro.com.au', 'phone': '88905555'}], 'overallOfficials': [{'name': 'Michael J Bourke, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Sydney Local Health District'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Professor Michael Bourke', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Director of Gastrointestinal Endoscopy', 'investigatorFullName': 'Professor Michael Bourke', 'investigatorAffiliation': 'Western Sydney Local Health District'}}}}