Ignite Creation Date:
2025-12-25 @ 1:43 AM
Ignite Modification Date:
2026-02-27 @ 4:08 PM
Study NCT ID:
NCT04151394
Status:
COMPLETED
Last Update Posted:
2019-11-18
First Post:
2019-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Side-to-side Duodenojejunostomy After Distal Duodenal Resection (DUORESECT)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2020-04-02', 'releaseDate': '2020-03-23'}, {'resetDate': '2021-05-17', 'releaseDate': '2021-04-26'}], 'estimatedResultsFirstSubmitDate': '2020-03-23'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D004379', 'term': 'Duodenal Neoplasms'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}], 'ancestors': [{'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': 'D004378', 'term': 'Duodenal Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}, 'targetDuration': '12 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-14', 'studyFirstSubmitDate': '2019-10-31', 'studyFirstSubmitQcDate': '2019-10-31', 'lastUpdatePostDateStruct': {'date': '2019-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complication', 'timeFrame': '90 days', 'description': 'Surgical complications rates'}, {'measure': 'Overall survival', 'timeFrame': '10 years', 'description': 'Patients overall survival after resection'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Duodenal Neoplasm', 'Gastrointestinal Disease', 'Surgery--Complications', 'Survival']}, 'descriptionModule': {'briefSummary': 'Lower partial duodenectomy could be indicated in case of injury, wide neck diverticulum, tumor invasion by other tumors such as retroperitoneal sarcoma and primary tumor of 3rd and 4th portion of the duodenum. Reconstruction after resection is usually performed by a end-to-end or end-to-side anastomosis.\n\nThe investigators analyze the short and long-term results of a case series with resection for various lesions in the third and fourth duodenal portions and reconstruction of the intestinal transit through side-to-side duodenojejunostomy', 'detailedDescription': "The investigators retrospectively looked at patients who, from January 2010 to December 2018, underwent surgical procedures for duodenal tumors or other type of primary lesions.\n\nPatients with primary duodenal lesions who underwent surgery were included in the study. Patients with secondary duodenal infiltration or liver and/or peritoneal metastasis found during intraoperative exploration were excluded. Similarly, if the surgeons appreciate the involvement of the pancreas during the procedure, for which they would have to perform a pancreaticoduodenectomy, the patient would be excluded.\n\nDiagnostic management included establishment of a medical history, performance of clinical examination and imaging tests, including endoscopic exploration and, when neoplasm was suspected, computerized tomography (CT) scan, to confirm the tumor origin and growth, as well as infiltration, if any, of adjacent structures. These also allowed to rule out distant metastases, and to assess resectability and the option for reconstruction according to the location.\n\nThe variables taken into account were age, sex, the American Society of Anesthesiologists (ASA) classification, preoperative examinations performed and type of lesion susppected as benign, duodenal adenocarcinoma or gastrointestinal stromal tumor (GIST). Perioperative clinical results, surgical approach, type of resection and reconstruction, and intraoperative complications were recorded. Details of the postoperative course were collected. Some of the key short-term data recorded included length of hospital stay, complications' ranking (according to the Clavien-Dindo score; 'severe complication' is defined as greater or equal to IIIa), re-operation, re-admission and operative mortality (\\< 90 days after operation). Some of the key long-term data recorded were, digestive symptoms along follow-up, specific disease-free survival (DFS) and overall survival (OS)"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who, from January 2010 to December 2018, underwent surgical procedures in our unit for duodenal tumors or other type of primary lesions.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with primary duodenal lesions who underwent surgery\n\nExclusion Criteria:\n\n* Secondary duodenal infiltration or liver and/or peritoneal metastasis found during intraoperative exploration'}, 'identificationModule': {'nctId': 'NCT04151394', 'acronym': 'DUORESECT', 'briefTitle': 'Side-to-side Duodenojejunostomy After Distal Duodenal Resection (DUORESECT)', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Extremadura'}, 'officialTitle': 'Side-to-side Duodenojejunostomy After Resection of Third and Fourth Duodenal Part With Pancreatic Preservation', 'orgStudyIdInfo': {'id': 'UE-CHUB 001-2019'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Duodenojejunostomy', 'type': 'PROCEDURE', 'description': 'Resection of duodenal lesions and reconstruction by duodenojejunostomy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08080', 'city': 'Badajoz', 'country': 'Spain', 'facility': 'Gerardo Blanco-Fernández', 'geoPoint': {'lat': 38.87789, 'lon': -6.97061}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Extremadura', 'class': 'OTHER'}, 'collaborators': [{'name': 'Complejo Hospitalario Universitario de Badajoz', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Surgery, Clinical Professor', 'investigatorFullName': 'Gerardo Blanco-Fernández', 'investigatorAffiliation': 'Universidad de Extremadura'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2020-03-23', 'type': 'RELEASE'}, {'date': '2020-04-02', 'type': 'RESET'}, {'date': '2021-04-26', 'type': 'RELEASE'}, {'date': '2021-05-17', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Gerardo Blanco-Fernández, Head of Surgery, Clinical Professor, Universidad de Extremadura'}}}}