Ignite Creation Date:
2025-12-24 @ 5:56 PM
Ignite Modification Date:
2025-12-28 @ 12:45 AM
Study NCT ID:
NCT03529968
Status:
COMPLETED
Last Update Posted:
2018-05-21
First Post:
2018-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Siewert Type I-II: CT, PET-CT, EUS Sensitivity/Specificity for the Assessment of Lymph Node Metastases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562730', 'term': 'Adenocarcinoma Of Esophagus'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016629', 'term': 'Esophagectomy'}, {'id': 'D005743', 'term': 'Gastrectomy'}], 'ancestors': [{'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Lymph nodes from surgical samples in patients submitted to surgical procedures for Siwert type I-II esophageal adenocarcinoma.'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-18', 'studyFirstSubmitDate': '2018-04-24', 'studyFirstSubmitQcDate': '2018-05-18', 'lastUpdatePostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-05-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Principal aim - sensitivity, specificity, accuracy', 'timeFrame': '1 years', 'description': 'The aim of this study was to evaluate sensitivity, specificity, accuracy of positron emission tomography integrated with CT (PET-CT), endoscopic ultrasound (EUS) and computed tomography (CT) for staging N descriptor in total (regional N) and in anatomical groups of thoracic and abdominal N stations.\n\nFor each lymph nodal station thoracic and abdominal the outcome measures for CT, PET; EUS were: Sensitivity measured in percentage (number of lymph nodes true positive/number of lymph nodes positive in the test x 100); Specificity measured in percentage (number of lymph nodes true negative/number of lymph nodes negative in the test x 100).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['esophageal adenocarcinoma', 'staging', 'CT', 'PET-CT', 'EUS'], 'conditions': ['Siewert Type I-II Adenocarcinoma of the Esophagus']}, 'referencesModule': {'references': [{'pmid': '30496443', 'type': 'DERIVED', 'citation': 'Lopci E, Kauppi J, Lugaresi M, Mattioli B, Daddi N, Fortunato F, Rasanen J, Mattioli S. Siewert type I and II oesophageal adenocarcinoma: sensitivity/specificity of computed tomography, positron emission tomography and endoscopic ultrasound for assessment of lymph node metastases in groups of thoracic and abdominal lymph node stations. Interact Cardiovasc Thorac Surg. 2019 Apr 1;28(4):518-525. doi: 10.1093/icvts/ivy314.'}]}, 'descriptionModule': {'briefSummary': 'In Siewert type I/II EAC, sensitivity/specificity of CT, PET-CT, EUS for assessment of N descriptor in defined groups of lymph nodes were investigated.', 'detailedDescription': "Esophageal adenocarcinoma (EAC) is a disease with poor overall prognosis and rising incidence in western countries. In patients without organ metastases, therapy is currently based on surgery with or without neoadjuvant therapy; indication for primary surgery is reserved to clinical TNM stages 0-IIa, whereas a multimodality approach is more suitable for clinical TNM stages IIb-III. The operation comprises the resection of distal esophagus and proximal or total gastrectomy. Two field lymphadenectomy is generally recommended, but the extent of lymphadenectomy is among the controversial issues, as extensive removal of nodes may cause significant morbidity and its effect on survival in addition to neoadjuvant therapy is not clear. Current guidelines are based on the 7th edition of AJCC \\& UICC TNM classification, which stages lymph node status (N) according to the number of metastatic nodes, but do not consider the specific anatomic stations of regional nodes. EAC subtypes are known to demonstrate different metastatic nodal patterns of spread. They may be classified with the Siewert's classification according to the position of the tumor with respect to the esophago-gastric junction (EGJ), or according to histologic parameters like the presence/absence of intestinal metaplasia in the esophagus and stomach. Siewert Type I EAC, which fairly corresponds to the Barret's like type according to the presence absence of intestinal metaplasia, spreads more likely to the thoracic nodal stations, while Siewert Type II and the pyloric like type, do spread more frequently to the perigastric and celiac stations. Therefore, an increasing interest is emerging for preoperative mapping of lymph nodes metastases in order to tailor surgery according to metastatic patterns.\n\nThe majority of studies aiming to assess the accuracy of N staging with clinical methods generally refer to the global evaluation of regional nodes according to the 7th edition of staging descriptors. Studies reporting specific data on the clinical staging assessment of specific thoracic and abdominal lymph nodal stations are few, diagnostic tests and results are not uniform, interpretation and comparison of data within reports is not immediate."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '101 patients affected by Siewert type I (n=60) and type II (n=41) EAC, submitted to up front surgery (no neoadjuvant therapy) in the Thoracic Surgery divisions of the University of Bologna (Maria Cecilia Hospital n=54) and of the Helsinki University Hospital (n=47).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Siewert type I-II adenocarcinoma \\> 18 year submitted to primary surgery\n\nExclusion Criteria:\n\n* Siewert type I-II adenocarcinoma submitted to neoadjuvant therapy.\n* Siewert type III adenocarcinoma Squamous Carcinoma'}, 'identificationModule': {'nctId': 'NCT03529968', 'acronym': 'ADECC2-2017', 'briefTitle': 'Siewert Type I-II: CT, PET-CT, EUS Sensitivity/Specificity for the Assessment of Lymph Node Metastases', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': 'Siewert Type I and II Esophageal Adenocarcinoma (EAC): CT, PET-CT, EUS Sensitivity / Specificity for the Assessment of Lymph Node Metastases (LNM) in Groups of Thoracic and Abdominal Lymph Nodal Stations', 'orgStudyIdInfo': {'id': 'ADECC2-2017'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Italian Siewert I-II adenocarcinoma', 'description': 'Patients with Siewert type I adenocarcinoma underwent subtotal esophagectomy and proximal gastrectomy with intrathoracic esophagogastric anastomosis. Patients with Siewert type II adenocarcinoma underwent total gastrectomy and esophageal resection at the level of the azygos vein and Roux-en-Y esophagojejunostomy. A right anterolateral thoracotomy and an upper midline laparotomy were performed as previously described. Lymphadenectomy included chest stations classified according to the AJCC TNM 7th edition (L/R = left/right; 3, 4R, 7, 2R, 8 and 9 and abdominal stations classified according to the Japanese Classification of Gastric Carcinoma (stations 1-12)', 'interventionNames': ['Procedure: esophagectomy']}, {'label': 'Finnish Siewert I-II adenocarcinoma', 'description': 'All Siewert type I/II patients underwent minimally invasive esophagectomy and reconstruction with gastric tube. Laparoscopy and right-sided thoracoscopy in decubitus position were used as previously described. Thoracic lymphadenectomy consisted of stations 7-9 (AJCC TNM 7th edition) and abdominal stations 1-3 and 7-11 according to the Japanese Classification of Gastric carcinoma.', 'interventionNames': ['Procedure: esophagectomy']}], 'interventions': [{'name': 'esophagectomy', 'type': 'PROCEDURE', 'otherNames': ['gastrectomy'], 'description': 'Subtotal esophagectomy and proximal gastrectomy with intrathoracic esophagogastric anastomosis. Total gastrectomy and esophageal resection at the level of the azygos vein and Roux-en-Y esophagojejunostomy', 'armGroupLabels': ['Finnish Siewert I-II adenocarcinoma', 'Italian Siewert I-II adenocarcinoma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40138', 'city': 'Bologna', 'state': 'Bo', 'country': 'Italy', 'facility': 'Department of Medical and Surgical Sciences University of Bologna', 'geoPoint': {'lat': 44.49381, 'lon': 11.33875}}], 'overallOfficials': [{'name': 'Sandro M Mattioli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Medical and Surgical Sciences University of Bologna'}, {'name': 'Sandro M Mattioli, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Medical and Surgical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sandro Mattioli', 'investigatorAffiliation': 'University of Bologna'}}}}