Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT00270751
Status:
UNKNOWN
Last Update Posted:
2006-08-07
First Post:
2005-12-26
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011030', 'term': 'Pneumothorax'}, {'id': 'C562573', 'term': 'cyclopia sequence'}], 'ancestors': [{'id': 'D010995', 'term': 'Pleural Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2005-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2006-08', 'completionDateStruct': {'date': '2009-05'}, 'lastUpdateSubmitDate': '2006-08-04', 'studyFirstSubmitDate': '2005-12-26', 'studyFirstSubmitQcDate': '2005-12-26', 'lastUpdatePostDateStruct': {'date': '2006-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recurrence rate of pneumothorax after thoracoscopic operation.'}], 'secondaryOutcomes': [{'measure': 'The short-term results (Pain level, chest tube duration, hospital stay, etc)'}, {'measure': 'Complication rate'}, {'measure': 'Long-term results: residual pain'}, {'measure': 'Long-term pulmonary function test'}]}, 'conditionsModule': {'keywords': ['Video-Assisted Thoracoscopic Surgery', 'Spontaneous pneumothorax', 'Pleurectomy', 'Pleural abrasion', 'Minocycline'], 'conditions': ['Pneumothorax']}, 'referencesModule': {'references': [{'pmid': '16357330', 'type': 'BACKGROUND', 'citation': 'Chen JS, Hsu HH, Chen RJ, Kuo SW, Huang PM, Tsai PR, Lee JM, Lee YC. Additional minocycline pleurodesis after thoracoscopic surgery for primary spontaneous pneumothorax. Am J Respir Crit Care Med. 2006 Mar 1;173(5):548-54. doi: 10.1164/rccm.200509-1414OC. Epub 2005 Dec 15.'}, {'pmid': '14718420', 'type': 'BACKGROUND', 'citation': 'Chen JS, Hsu HH, Kuo SW, Tsai PR, Chen RJ, Lee JM, Lee YC. Effects of additional minocycline pleurodesis after thoracoscopic procedures for primary spontaneous pneumothorax. Chest. 2004 Jan;125(1):50-5. doi: 10.1378/chest.125.1.50.'}, {'pmid': '22323011', 'type': 'DERIVED', 'citation': 'Chen JS, Hsu HH, Huang PM, Kuo SW, Lin MW, Chang CC, Lee JM. Thoracoscopic pleurodesis for primary spontaneous pneumothorax with high recurrence risk: a prospective randomized trial. Ann Surg. 2012 Mar;255(3):440-5. doi: 10.1097/SLA.0b013e31824723f4.'}]}, 'descriptionModule': {'briefSummary': 'Optimal surgical management of primary spontaneous pneumothorax has been a matter of devate, especially regarding the method of pleurodesis. Previous studies have shown that thoracoscopic apical pleurectomy is a reliable method with a very low incidence of recurrence. However, this procedure is more technical demanding and time consuming through thoracoscopy. In addition, a more extensive pleural injury may cause impaired pulmonary function and a higher risk of perioperative complication such as hemothorax. In our previous studies, we have shown that thoracoscopic pleural abrasion with minocycline instillation is an easy and convinent method of pleurodesis which decreases the rate of recurrence without affecting pulmonary function. In this study, we hypothesized that pleural abrasion with minocycline instillation is as effective as apical pleurectomy in preventing pneumothorax recurrence while the short-term and long-term complications are less.', 'detailedDescription': 'Optimal surgical management of primary spontaneous pneumothorax has been a matter of devate, especially regarding the method of pleurodesis. Previous studies have shown that thoracoscopic apical pleurectomy is a reliable method with a very low incidence of recurrence. However, this procedure is more technical demanding and time consuming through thoracoscopy. In addition, a more extensive pleural injury may cause impaired pulmonary function and a higher risk of perioperative complication such as hemothorax. In our previous studies, we have shown that thoracoscopic pleural abrasion with minocycline instillation is an easy and convinent method of pleurodesis which decreases the rate of recurrence without affecting pulmonary function. In this study, we hypothesized that pleural abrasion with minocycline instillation is as effective as apical pleurectomy in preventing pneumothorax recurrence while the short-term and long-term complications are less.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age between 15 and 50 years old Undergoing thoracoscopic bullectomy Had multiple blebs or no identified blebs during the operation\n\nExclusion Criteria:\n\n* With underlying pulmonary disease With major systemic disease or acute infection Underwent ipsilateral operation previously Bleb number = 1 or 2'}, 'identificationModule': {'nctId': 'NCT00270751', 'briefTitle': 'Pleural Abrasion Plus Minocycline Versus Apical Pleurectomy for Primary Spontaneous Pneumothorax', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Comparison of Pleural Abrasion Plus Minocycline Pleurodesis Versus Apical Pleurectomy After Thoracoscopic Bullectomy for High Recurrent Risk Patients With Primary Spontaneous Pneumothorax: A Prospective Randomized Trial.', 'orgStudyIdInfo': {'id': '31MD02'}}, 'armsInterventionsModule': {'interventions': [{'name': '1 apical pleurectomy', 'type': 'PROCEDURE'}, {'name': '2 pleural abrasion + minocycline pleurodesis', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Jin-Shing Chen, MD, PhD', 'role': 'CONTACT', 'email': 'cjs@ha.mc.ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '5178'}, {'name': 'Yung-Chie Lee, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Jin-Shing Chen, MD, PhD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Yung-Chie Lee, MD, PhD', 'role': 'CONTACT', 'email': 'wuj@ha.mc.ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '5070'}, {'name': 'Jin-Shing Chen, MD, PhD', 'role': 'CONTACT', 'email': 'cjs@ha.mc.ntu.edu.tw', 'phone': '886-2-23123456', 'phoneExt': '5178'}], 'overallOfficials': [{'name': 'Yung-Chie Lee, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Surgery, National Taiwan University Hospital, Taiwan'}, {'name': 'Jin-Shing Chen, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Surgery, National Taiwan University Hospital, Taiwan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}]}}}