Ignite Creation Date:
2025-12-24 @ 5:46 PM
Ignite Modification Date:
2025-12-30 @ 2:49 AM
Study NCT ID:
NCT00500968
Status:
COMPLETED
Last Update Posted:
2011-04-07
First Post:
2007-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010190', 'term': 'Pancreatic Neoplasms'}, {'id': 'D005402', 'term': 'Fistula'}], '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'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015607', 'term': 'Stents'}, {'id': 'D002760', 'term': 'Cholangiopancreatography, Endoscopic Retrograde'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}], 'ancestors': [{'id': 'D019736', 'term': 'Prostheses and Implants'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D002758', 'term': 'Cholangiography'}, {'id': 'D011860', 'term': 'Radiography, Abdominal'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D003938', 'term': 'Diagnostic Techniques, Digestive System'}, {'id': 'D016145', 'term': 'Endoscopy, Digestive System'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013505', 'term': 'Digestive System Surgical Procedures'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-09', 'completionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-06', 'studyFirstSubmitDate': '2007-07-12', 'studyFirstSubmitQcDate': '2007-07-12', 'lastUpdatePostDateStruct': {'date': '2011-04-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Drain fluid content analyses', 'timeFrame': 'At least 5 postoperative days', 'description': 'Post-operative daily measurement of X-Amylase,as long as the patient has the external drain and for at least 5 postopertaive days.'}], 'secondaryOutcomes': [{'measure': 'Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization and cost. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent', 'timeFrame': 'At least 5 postoperative days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Pancreas', 'Leakage', 'Fistula', 'tail'], 'conditions': ['Pancreas Cancer', 'Fistula']}, 'referencesModule': {'references': [{'pmid': '22584629', 'type': 'DERIVED', 'citation': 'Frozanpor F, Lundell L, Segersvard R, Arnelo U. The effect of prophylactic transpapillary pancreatic stent insertion on clinically significant leak rate following distal pancreatectomy: results of a prospective controlled clinical trial. Ann Surg. 2012 Jun;255(6):1032-6. doi: 10.1097/SLA.0b013e318251610f.'}]}, 'descriptionModule': {'briefSummary': 'Randomized study assessing the effect of transpapillary pancreas duct stent in resection of the pancreatic tail.', 'detailedDescription': 'Resection of the pancreatic tail is fraught with fistula or leakage of pancreatic enzymes to varying degrees between 13-64%, depending upon which definition one uses. The "downstream" control of the pancreatic duct with the help of a transpapillary stent might minimize the risk for leakage over the transected pancreas surface.\n\nTrial evaluation will be A. The pancreatic bed was drained and postoperatively the fluid was continuously collected and daily analysed for pancreatic amylase and bilirubin. Daily measurement of pancreatic enzyme content in the drain fluid, at least for 5 post operative days or as long as the patient retains the drain. X-Amylase and X-Protein as long as the patient has the external drain.\n\nB. Co-variables measured in the form of: operation time, complications in relation to diagnosis, duration of hospitalization. Patients receiving a pancreas stent are followed in order to evaluate the natural course of the pancreas stent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion Criteria include all patients planned to undergo resection of the pancreatic body-tail are invited to participate.\n\nExclusion Criteria:\n\n* The Patients who, at the time of exploration, judged to have a tumour, which is un-resectable.'}, 'identificationModule': {'nctId': 'NCT00500968', 'briefTitle': 'Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'Randomized Study Assessing the Effect of Transpapillary Pancreas Duct Stent in Resection of the Pancreatic Tail', 'orgStudyIdInfo': {'id': '2006/3:3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Stent', 'interventionNames': ['Procedure: stent']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'conventional distal pancreatectomy', 'interventionNames': ['Procedure: Distal pancreatectomy']}], 'interventions': [{'name': 'stent', 'type': 'PROCEDURE', 'otherNames': ['ERCP'], 'description': 'ERCP guided stent insertion before transection of the gland', 'armGroupLabels': ['Stent']}, {'name': 'Distal pancreatectomy', 'type': 'PROCEDURE', 'otherNames': ['surgery'], 'description': 'conventional distal pancreatectomy', 'armGroupLabels': ['conventional distal pancreatectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14186', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinksa university hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Urban Arnelo', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Karolinksa university hospital'}, {'name': 'Farshad Frozanpor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Karolinksa university hospital'}, {'name': 'Lars Lundell, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Karolinska Institutet'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Karoliska instuitut', 'oldOrganization': 'Farshad Frozanpor'}}}}