Ignite Creation Date:
2025-12-25 @ 2:19 AM
Ignite Modification Date:
2025-12-26 @ 5:08 PM
Study NCT ID:
NCT00733434
Status:
UNKNOWN
Last Update Posted:
2009-10-27
First Post:
2008-08-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Use of Prostaglandin E1 in Head and Neck Microsurgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000527', 'term': 'Alprostadil'}, {'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D011458', 'term': 'Prostaglandins E'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005229', 'term': 'Fatty Acids, Monounsaturated'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 242}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-10', 'completionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-10-26', 'studyFirstSubmitDate': '2008-08-12', 'studyFirstSubmitQcDate': '2008-08-12', 'lastUpdatePostDateStruct': {'date': '2009-10-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-08-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Free flap re-exploration rate', 'timeFrame': '7 days after microsurgery'}], 'secondaryOutcomes': [{'measure': 'Surgical complication rate', 'timeFrame': 'hospitalization period'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Microsurgery', 'Head and neck', 'Prostaglandin E1', 'Thrombosis', 'Complication'], 'conditions': ['Microsurgery', 'Head and Neck', 'Prostaglandin E1', 'Thrombosis', 'Complications']}, 'referencesModule': {'references': [{'pmid': '14578781', 'type': 'BACKGROUND', 'citation': 'Disa JJ, Polvora VP, Pusic AL, Singh B, Cordeiro PG. Dextran-related complications in head and neck microsurgery: do the benefits outweigh the risks? A prospective randomized analysis. Plast Reconstr Surg. 2003 Nov;112(6):1534-9. doi: 10.1097/01.PRS.0000083378.58757.54.'}, {'pmid': '17596843', 'type': 'BACKGROUND', 'citation': 'Rodriguez Vegas JM, Ruiz Alonso ME, Teran Saavedra PP. PGE-1 in replantation and free tissue transfer: early preliminary experience. Microsurgery. 2007;27(5):395-7. doi: 10.1002/micr.20377.'}, {'pmid': '17589257', 'type': 'BACKGROUND', 'citation': 'Ashjian P, Chen CM, Pusic A, Disa JJ, Cordeiro PG, Mehrara BJ. The effect of postoperative anticoagulation on microvascular thrombosis. Ann Plast Surg. 2007 Jul;59(1):36-9; discussion 39-40. doi: 10.1097/01.sap.0000264837.15110.2f.'}, {'pmid': '12628901', 'type': 'BACKGROUND', 'citation': 'Watanabe H, Anayama S, Horiuchi T, Sato E, Hamada Y, Ishihara H. Pleural effusion caused by prostaglandin E1 preparation. Chest. 2003 Mar;123(3):952-3. doi: 10.1378/chest.123.3.952.'}, {'pmid': '12058249', 'type': 'BACKGROUND', 'citation': 'Barthelmes L, Chezhian C, Aihaku EK. Deep venous thrombosis and venous thrombophlebitis associated with alprostadil treatment for erectile dysfunction. Int J Impot Res. 2002 Jun;14(3):199-200. doi: 10.1038/sj.ijir.3900853.'}, {'pmid': '11901464', 'type': 'BACKGROUND', 'citation': 'Lee KS, Suh JD, Han SB, Yoo JC, Lee SJ, Cho SJ. The effect of aspirin and prostaglandin E(1) on the patency of microvascular anastomosis in the rats. Hand Surg. 2001 Dec;6(2):177-85. doi: 10.1142/s0218810401000643.'}]}, 'descriptionModule': {'briefSummary': 'Prostaglandin E1 (PGE1 )has been shown to have vasodilatation and anti-thrombosis effects, so it is used by some surgeons after microsurgery to keep the patency of the anastomosed small vessels. However, PGE 1 may also causes some complications, like pleural effusion or deep vein thrombosis. Therefore, it remains uncertain whether a routine use of PGE 1 after head and neck microsurgery is justified. We aim to test the hypothesis that PGE 1 increases postoperative vessel patency rate in patients undergoing head and neck microsurgery, with a comparable complication rate as the control group.', 'detailedDescription': 'Despite meticulous microsurgical techniques, free flap failure due to postoperative vessel thrombosis cannot be completely eliminated. Postoperative pharmacological augmentation of the established blood flow is considered as a feasible solution to this problem. Prostaglandin E1 (PGE1 )has been shown to have vasodilatation and anti-thrombosis effects, so it is used by some surgeons after microsurgery to keep the patency of the anastomosed small vessels. However, PGE 1 may also causes some complications, like pleural effusion or deep vein thrombosis. Therefore, it remains uncertain whether a routine use of PGE 1 in every patient after head and neck microsurgery is justified. We aim to test the hypothesis that PGE 1 increases postoperative vessel patency rate in patients undergoing head and neck microsurgery, and yielded a comparable complication rate as the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients requiring microvascular reconstruction after head and neck cancer resection\n\nExclusion Criteria:\n\n* Patients with coagulation dysfunction'}, 'identificationModule': {'nctId': 'NCT00733434', 'acronym': 'PGE1HNM', 'briefTitle': 'The Use of Prostaglandin E1 in Head and Neck Microsurgery', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Phase 4 Study of Postoperative Prostaglandin E1 in Head and Neck Microsurgery', 'orgStudyIdInfo': {'id': '200707036R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients receiving PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days', 'interventionNames': ['Drug: Prostaglandin E1']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Patients receiving 500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'Prostaglandin E1', 'type': 'DRUG', 'otherNames': ['Alprostadil, Promostan'], 'description': 'PGE 1 80mcg/500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days', 'armGroupLabels': ['1']}, {'name': 'Saline', 'type': 'OTHER', 'otherNames': ['Normal saline'], 'description': '500 ml saline continuous intravenous infusion per day after head and neck microsurgery for 5 days', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Yueh-Bih Tang, MD, PhD', 'role': 'CONTACT', 'email': 'phoebetang@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '5107'}, {'name': 'Yueh-Bih Tang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yueh-Bih Tang, MD, PhD', 'role': 'CONTACT', 'email': 'phoebetang@ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '5107'}], 'overallOfficials': [{'name': 'Yueh-Bih Tang, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Yueh-Bih Tang, Professor of Surgery', 'oldOrganization': 'National Taiwan University Hospital'}}}}