Ignite Creation Date:
2025-12-24 @ 1:17 PM
Ignite Modification Date:
2025-12-28 @ 7:32 PM
Study NCT ID:
NCT01033695
Status:
COMPLETED
Last Update Posted:
2009-12-16
First Post:
2009-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interobserver Agreement of Endoscopic Ultrasonography and Endoscopic Sonoelastography in the Evaluation of Lymph Nodes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004938', 'term': 'Esophageal Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}, {'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D009369', 'term': 'Neoplasms'}], 'ancestors': [{'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D004935', 'term': 'Esophageal Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008107', 'term': 'Liver Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-12-15', 'studyFirstSubmitDate': '2009-12-15', 'studyFirstSubmitQcDate': '2009-12-15', 'lastUpdatePostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-06', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Endoscopy', 'Endoscopic Ultrasound', 'Endoscopic Sonoelastography', 'Cancer', 'Interobserver agreement'], 'conditions': ['Lymph Nodes', 'Esophageal Cancer', 'Gastric Cancer', 'Pancreatic Cancer', 'Liver Cancer']}, 'descriptionModule': {'briefSummary': 'Endoscopic ultrasound (EUS) is an important part of the pre-treatment evaluation of patients with upper gastrointestinal tract cancer (esophageal, gastric, pancreatic and liver cancer). When planning the optimal therapy in patients with upper gastrointestinal malignancies it is essential to know the exact lymph node stage. Recently endoscopic sonoelastography(ES) has been added to conventional EUS examination and may provide complementary information to distinguish benign for malignant lymph nodes.\n\nThe N-stage relates to the treatment choice and the prognosis, and it is therefore of particular interest to know the interobserver agreement in operator dependent techniques. This study evaluate the interobserver agreement of EUS and ES evaluation og lymph nodes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients referred for EUS examination on the basis of a malignant indication.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* the presence of a lymph node more than 10mm in diameter (short axis) detected during the EUS examination\n\nExclusion Criteria:\n\n* inadequate ES images were obtained by one of the observers'}, 'identificationModule': {'nctId': 'NCT01033695', 'briefTitle': 'Interobserver Agreement of Endoscopic Ultrasonography and Endoscopic Sonoelastography in the Evaluation of Lymph Nodes', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Interobserver Agreement of Endoscopic Ultrasonography and Endoscopic Sonoelastography in the Evaluation of Lymph Nodes', 'orgStudyIdInfo': {'id': '12-2009'}}, 'contactsLocationsModule': {'locations': [{'zip': '5000', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Centre for Surgical Ultrasound', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}], 'overallOfficials': [{'name': 'Michael H. Larsen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Odense University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Michael Bau Mortensen', 'oldOrganization': 'Centre of Surgical Ultrasound'}}}}