Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2025-12-26 @ 2:21 AM
Study NCT ID:
NCT06993402
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-05-28
First Post:
2024-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
DESI - Düsseldorfer ESD Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003110', 'term': 'Colonic Neoplasms'}], 'ancestors': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-09-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2035-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-20', 'studyFirstSubmitDate': '2024-12-02', 'studyFirstSubmitQcDate': '2025-05-20', 'lastUpdatePostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2035-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Technical success rate', 'timeFrame': 'during the procedure', 'description': 'TSR, defined as rate of procedures with endoscopic en-bloc resection'}, {'measure': 'Complication rate', 'timeFrame': 'through study completion, an average of 5 years', 'description': 'Serious complications, (according to AGREE criteria), intraprocedural or late onset'}, {'measure': 'Histopahological result', 'timeFrame': 'up to 14 days after Procedure', 'description': 'Histopathological result of R0 resection (margins are clean, vertical and lateral)'}], 'secondaryOutcomes': [{'measure': 'Complete resection rate (endoscopic)', 'timeFrame': 'up to 14 days after Procedure till histopathological results'}, {'measure': 'Clinical success rate (curative resection according to standard of care guidelines)', 'timeFrame': 'up to 14 days after Procedure till histopathological results'}, {'measure': 'Enhances clinical success rate (no curative resection according to standard of care guidelines, but no further treatment necessary (after individual discussion of cases in tumorboard)', 'timeFrame': 'about 4 weeks after the ESD'}, {'measure': 'Complication rate (total)', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Contributing factors on the technical and clinical success rate originating with patient and investigator aspects', 'timeFrame': 'through study completion, an average of 1 year'}, {'measure': 'Dissection speed and rate of complications with different ESD devices', 'timeFrame': 'during the procedure / 1 day'}, {'measure': 'Recurrence rate after 3, 6, 12, 24 and 60 months (if available)', 'timeFrame': 'through study completion, an average of 5 year'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ESD'], 'conditions': ['Oesophageal Tumour', 'Gastric Tumours', 'Duodenal Tumours', 'Colon Tumours', 'Rectal Tumours']}, 'descriptionModule': {'briefSummary': 'Safety and effectiveness of endoscopic submucosal dissection', 'detailedDescription': 'Background and study objective The standard of care for premalignant and malignant mucosal lesions in the gastrointestinal track with limited submucosal invasion is an endoscopic resection. A curative resection of the neoplasia often necessitates an en-bloc resection, where the resection ends within healthy tissue (R0 resection). Endoscopic submucosal dissection (ESD) is a highly sophisticated resection technique for lesions in the oesophagus, stomach, duodenum, colon and rectum. Multiple studies in Asia already established the safety and efficacy of ESD. In several spezialized centres in the western world the ESD already replaced the endoscopic mucosal resectiona (EMR) as standart of care. The en-bloc resection facilitates an exact histopathological evaluation, thus leading to lower recurrence rates. Besides specified mucosal lesions, there is an increase in the use of ESD to resect expansive and submucosal lesions. Specialised centres like Evangelisches Krankenhaus Düsseldorf have a high number of ESD cases and use ubiquitous in the gastrointestinal tract. Besides the many advantages over EMR there is still the risk of peri- and postinterventional complications with ESD due to the highly demanding technique and the longer procedure duration. This is why patient selection is crucial factor (in this study). To evaluate the safety and efficacy of ESD more prospective data analysis in western centres are necessary. This data will be useful to develop new approaches to improve the method concerning safety and efficacy and patient selection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with epithelial gastrointestinal lesions who receive an endoscopic submucosal dissection in the oesophagus, stomach, duodenum, colon or rectum in accordance with the guidelines (or according to the individual decision of the interdisciplinary tumour conference).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* signed consent form\n* Indication for an ESD in the oesophagus, stomach, duodenum, colon or rectum\n* Age \\>18 years\n\nExclusion Criteria:\n\n* Age \\< 18 years'}, 'identificationModule': {'nctId': 'NCT06993402', 'briefTitle': 'DESI - Düsseldorfer ESD Study', 'organization': {'class': 'OTHER', 'fullName': 'Evangelisches Krankenhaus Düsseldorf'}, 'officialTitle': 'DESI- Düsseldorfer ESD Register Study', 'orgStudyIdInfo': {'id': 'DESI'}}, 'contactsLocationsModule': {'locations': [{'zip': '40217', 'city': 'Düsseldorf', 'state': 'North Rhine-Westphalia', 'country': 'Germany', 'facility': 'Evangelisches Krankenhaus Düsseldorf', 'geoPoint': {'lat': 51.22172, 'lon': 6.77616}}], 'overallOfficials': [{'name': 'Torsten PD Dr. med Beyna', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Evangelisches Krankenhaus Düsseldorf'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Torsten Beyna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of the Medical Clinic and Gastroenterology', 'investigatorFullName': 'Torsten Beyna', 'investigatorAffiliation': 'Evangelisches Krankenhaus Düsseldorf'}}}}