Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT00906802
Status:
UNKNOWN
Last Update Posted:
2009-07-23
First Post:
2009-05-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Benefit of Roux-en-Y (R-Y) Reconstruction After Pancreaticoduodenectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}], 'ancestors': [{'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2003-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-07', 'completionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-07-22', 'studyFirstSubmitDate': '2009-05-19', 'studyFirstSubmitQcDate': '2009-05-20', 'lastUpdatePostDateStruct': {'date': '2009-07-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'the incidence of DGE', 'timeFrame': '3-6 months'}], 'secondaryOutcomes': [{'measure': 'the incidence of other complication associated with reconstruction', 'timeFrame': '3-6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pancreaticoduodenectomy', 'reconstruction'], 'conditions': ['Pancreatic Cancer']}, 'descriptionModule': {'briefSummary': 'One of the most common complications of pancreaticoduodenectomy (PD) is delayed gastric emptying (DGE), otherwise known as "gastroparesis," which is not fatal but results in prolonged hospital stay and increased hospital costs. Delayed gastric emptying is defined as nasogastric decompression after postoperative day (POD) 10 or a failure to tolerate a regular diet after POD 14. The incidence of DGE has been reported to range from 5% to 72%.', 'detailedDescription': 'We hypothesized that the hand-sewn, two-layered, or continuous suture, could induce anastomotic edema to indeed the afferent peristalsis, which is one of the causes of DGE.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '30 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* These patients were to undergo elective pancreatic head resection for the treatment of periampullary mass\n\nExclusion Criteria:\n\n* A body weight loss greater than 10% during the six months prior to surgery\n* The presence of distant metastases\n* Seriously impaired function of vital organs due to respiratory, renal or heart disease'}, 'identificationModule': {'nctId': 'NCT00906802', 'briefTitle': 'Benefit of Roux-en-Y (R-Y) Reconstruction After Pancreaticoduodenectomy', 'organization': {'class': 'OTHER', 'fullName': 'Kochi University'}, 'officialTitle': 'Benefit of R-Y Reconstruction After Pancreaticoduodenectomy', 'orgStudyIdInfo': {'id': 'RPD Study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'R-Y reconstruction', 'description': 'the reconstruction was performed by R-Y anastomosis', 'interventionNames': ['Procedure: R-Y reconstruction']}, {'type': 'NO_INTERVENTION', 'label': 'conventional reconstruction', 'description': 'the anastomosis was performed by B-II'}], 'interventions': [{'name': 'R-Y reconstruction', 'type': 'PROCEDURE', 'otherNames': ['the cutting R-Y anastmosis'], 'description': 'The reconstruction was performed by R-Y anastomosis.', 'armGroupLabels': ['R-Y reconstruction']}]}, 'contactsLocationsModule': {'locations': [{'zip': '783-8505', 'city': 'Nankoku', 'state': 'Kochi', 'status': 'RECRUITING', 'country': 'Japan', 'contacts': [{'name': 'Takehiro Okabayashi, MD, PhD', 'role': 'CONTACT', 'email': 'tokabaya@kochi-u.ac.jp', 'phone': '81-88-880-2370'}, {'name': 'Kazuhiro Hanazaki, Prof', 'role': 'CONTACT', 'email': 'im31@kochi-u.ac.jp', 'phone': '81-88-880-2370'}], 'facility': 'Kochi Medical School', 'geoPoint': {'lat': 33.56943, 'lon': 133.64937}}], 'centralContacts': [{'name': 'Takehiro Okabayashi, MD, PhD', 'role': 'CONTACT', 'email': 'tokabaya@kochi-u.ac.jp', 'phone': '81-88-880-2370'}, {'name': 'Kazuhiro Hanazaki, Prof', 'role': 'CONTACT', 'email': 'im31@kochi-u.ac.jp', 'phone': '81-88-880-2370'}], 'overallOfficials': [{'name': 'Kazuhiro Hanazaki, Prof', 'role': 'STUDY_CHAIR', 'affiliation': 'Kochi University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kochi University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Kochi Medical School', 'oldOrganization': 'Kochi University'}}}}