Ignite Creation Date:
2025-12-24 @ 1:32 PM
Ignite Modification Date:
2026-01-29 @ 3:42 PM
Study NCT ID:
NCT01635595
Status:
COMPLETED
Last Update Posted:
2012-07-25
First Post:
2012-07-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nodal Status in Adenocarcinoma of the Esophagus an Cardia
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 194}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-24', 'studyFirstSubmitDate': '2012-07-03', 'studyFirstSubmitQcDate': '2012-07-06', 'lastUpdatePostDateStruct': {'date': '2012-07-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-09', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Adenocarcinoma of the Esophagus', 'Adenocarcinoma of the Gastric Cardia']}, 'referencesModule': {'references': [{'pmid': '11553218', 'type': 'BACKGROUND', 'citation': "Mattioli S, Di Simone MP, Ferruzzi L, D'Ovidio F, Pilotti V, Carella R, D'Errico A, Grigioni WF. Surgical therapy for adenocarcinoma of the cardia: modalities of recurrence and extension of resection. Dis Esophagus. 2001;14(2):104-9. doi: 10.1046/j.1442-2050.2001.00165.x."}, {'pmid': '17462405', 'type': 'RESULT', 'citation': "Mattioli S, Ruffato A, Di Simone MP, Corti B, D'Errico A, Lugaresi ML, Mattioli B, D'Ovidio F. Immunopathological patterns of the stomach in adenocarcinoma of the esophagus, cardia, and gastric antrum: gastric profiles in Siewert type I and II tumors. Ann Thorac Surg. 2007 May;83(5):1814-9. doi: 10.1016/j.athoracsur.2007.01.016."}]}, 'descriptionModule': {'briefSummary': "Adenocarcinoma of the distal esophagus and cardia are grouped among the thoracic tumors according to the TNM 7th ed., however controversy is pending on the unique or dual pathogenesis (GERD or gastric-like cancerogenesis). It has been shown that biological patterns differ according to the presence (+) or absence (-) of Barrett's epithelium (BIM) and gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic spreading may differ according to the type of tumor. The investigators retrospectively investigated the pathways of lymphatic spreading in 194 consecutive patients who received radical surgery for adenocarcinoma of the esophagus and cardia with or without BIM and GIM.", 'detailedDescription': "The assumption that adenocarcinoma of the esophagus and cardia (ADEC) originates only from the sequence intestinal metaplasia followed by dysplasia and cancer is controversial. It has been shown that biological patterns differ according to the presence (+) absence (-) of Barrett's epithelium (BIM) and of gastric intestinal metaplasia (GIM) in the fundus and antrum. Lymphatic metastatic spreading may differ according to the type of tumor.\n\nPreoperatively patients underwent histological search for Barrett's esophagus (BIM) in mucosa surrounding (ADEC) and intestinal metaplasia in the gastric corpus and antrum mucosa (GIM). Patients in which BIM was documented underwent sub total esophagectomy and gastric pull up (group 1), others underwent esophagectomy at the azygos vein + total gastrectomy with Roux Y esophagojejunostomy (group 2). Radical lymphadenectomy was identical in both procedures except for the greater curvature station."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a preoperative diagnosis of adenocarcinoma of the distal esophagus and cardia who underwent surgery up to December 2011, which fully adhered to the pre and postoperative protocol, including endoscopic gastric mucosa sampling.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* preoperative diagnosis of adenocarcinoma of the distal esophagus and cardia\n* preoperative from local to locally advanced disease\n* absence of neoadjuvant therapy\n\nExclusion Criteria:\n\n* neoadjuvant therapy\n* metastatic disease\n* unfit for surgery'}, 'identificationModule': {'nctId': 'NCT01635595', 'briefTitle': 'Nodal Status in Adenocarcinoma of the Esophagus an Cardia', 'organization': {'class': 'OTHER', 'fullName': 'University of Bologna'}, 'officialTitle': 'AdCa of the Esophagus and Cardia (ADEC): Relationship Between Nodal Metastasization and the Presence Absence of Intestinal Metaplasia in the Esophagus and Stomach', 'orgStudyIdInfo': {'id': 'Cardia AdCa UNIBO'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with BIM', 'description': 'Patients affected by adenocarcinoma of the distal esophagus and cardia with preoperative diagnosis of BIM underwent subtotal esophagectomy and gastric pull up.', 'interventionNames': ['Procedure: Subtotal esophagectomy and gastric pull up']}, {'label': 'Patients without BIM', 'description': 'Patients affected by adenocarcinoma of the distal esophagus and cardia without preoperative diagnosis of BIM underwent subtotal esophagectomy at the azygos vein, total gastrectomy and esophagojejunostomy.', 'interventionNames': ['Procedure: Subtotal esophagectomy at the azygos vein, total gastrectomy']}], 'interventions': [{'name': 'Subtotal esophagectomy and gastric pull up', 'type': 'PROCEDURE', 'otherNames': ['Esophagectomy'], 'description': 'Subtotal esophagectomy and gastric pull up and radical thoracic (2,3,4R,7,8,9)and abdominal (15,16,17,18,19,20) lymphadenectomy', 'armGroupLabels': ['Patients with BIM']}, {'name': 'Subtotal esophagectomy at the azygos vein, total gastrectomy', 'type': 'PROCEDURE', 'otherNames': ['Esophagectomy', 'Gastrectomy'], 'description': 'Subtotal esophagectomy at the azygos vein, total gastrectomy and esophagojejunostomy and radical thoracic (2,3,4R,7,8,9) abdominal (15,16,17,18,19,20) lymphadenectomy.', 'armGroupLabels': ['Patients without BIM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48010', 'city': 'Cotignola', 'state': 'Ravenna', 'country': 'Italy', 'facility': 'Division of Thoracic Surgery, Center for the Study and Therapy of Diseases of the Esophagus. Alma Mater Studiorum - University of Bologna, GVM Care & Research, Maria Cecilia Hospital', 'geoPoint': {'lat': 44.38572, 'lon': 11.93852}}], 'overallOfficials': [{'name': 'Sandro Mattioli, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Bologna'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Bologna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Sandro Mattioli', 'investigatorAffiliation': 'University of Bologna'}}}}