Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201602001308660 Date of Approval: 15/10/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title interventional pulmonology
Official scientific title Bronchoscopic Lung Volume Reduction With Silver Nitrate Instillation In Patients With Emphysema, efficacy and safety
Brief summary describing the background and objectives of the trial Emphysema is a parenchymal tissue destruction resulting from chronic inflammatory response to inhaled cigarette smoke and other noxious agents that disrupt normal repair mechanisms and results in small airway fibrosis. These pathological changes lead to air trapping and progressive air flow limitation. Surgical lung volume reduction (LVRS) can be performed for patients with advanced emphysema. However, serious post-surgical complications, including cardiac ischaemia, arrhythmia and pulmonary embolus, were observed more frequently. Lung transplantation also improves pulmonary function, symptoms, functional capacity, and quality of life in patients with advanced emphysema, but Chronic rejection remains a major unresolved problem among patients who undergo lung transplantation, and is associated with a 50% 5 year mortality. Therefore, minimally invasive techniques had been proposed to reduce lung volume in those patients without undergoing open thoracotomy. Different endoscopic LVR (ELVR) systems are undergoing evaluation to avoid surgical LVRS without the concomitant surgical morbidity and mortality. For example, endobronchial valve and endobronchial coils but the cost of these methods is high. Silver nitrate is a cauterizing agent if applied to the mucosa it will lead to coagulation of cellular protein with eschar formation, degenerative changes in the musculature and the bronchial wall and surrounding parenchyma showed marked edema so, if silver nitrate is applied to bronchial mucosa, it will lead to bronchial mucosa swelling and ulceration with subsequent complete stenosis of airway.The aim of work is to assess the efficacy and safety of use of Silver Nitrate in bronchoscopic lung.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied ,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Drugs
Anticipated trial start date 15/04/2015
Actual trial start date 01/05/2015
Anticipated date of last follow up 01/05/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 0
Actual target sample size (number of participants) 40
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Bronchoscopic Lung Volume Reduction. Autologous blood 3 minutes minimally invasive, non surgical bronchoscopic lung volume reduction with silver nitrate solution 0.5% 20
Experimental Group Bronchoscopic Lung Volume Reduction. 1 ml of silver nitrate solution in each bronchial segment. 3 minutes minimally invasive, non surgical bronchoscopic lung volume reduction with silver nitrate solution 0.5% 20
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
¿ COPD of grades III and IV according to GOLD staging of COPD. ¿ Patients with any grade of COPD with localized emphysema. ¿ Age of patient less than 75 years. ¿ FEV1 less than 40%. ¿ RV more than 100% of predicted value. ¿ TLC more than 100% of predicted value. ¿ 6 MWT less than 450 m. ¿ Hetrogenous emphysema. ¿ Significant comorbidity that limits exercise capacity or prognosis, ¿ Patients unfit for FOB. ¿ Homogenous emphysema. 20 Year(s) 75 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 07/09/2015 IRB
Ethics Committee Address
Street address City Postal code Country
Al gomhorya St, Faculty of medicine , Mansoura university Mansoura Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome change in volumetry of emphysematous part 3 months
Secondary Outcome quality of life score 3 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mansoura university hospital, Chest department Al gomhorya St Mansoura Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Mansoura University Hospital Al gomhorya St, Mansoura Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Mansoura university hospital Al gomhorya St. Mansoura Egypt Hospital
COLLABORATORS
Name Street address City Postal code Country
Mansoura university hospital Al gomhorya St Mansoura Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Mohammed El Hanafy elhanafy_mohammed@yahoo.com 01119399747 Al gomhorya St, Mansoura university Hospital
City Postal code Country Position/Affiliation
Mansoura Egypt Assistant lecturer
Role Name Email Phone Street address
Public Enquiries Mohammed El Hanafy elhanafy_mohammed@man.edu.eg +201119399747 Al gomhorya St, Mansoura university Hospital
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant lecturer
Role Name Email Phone Street address
Scientific Enquiries mohammed El Hanafy elhanafy_mohammed@mans.edu.eg +201119399747 Al gomhorya St, Mansoura university Hospital
City Postal code Country Position/Affiliation
Mansoura 35516 Egypt Assistant lecturer
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information