DIVision of the Interlobar Fissure in Patients Who Do Not Respond to Endobronchial Lung Volume Reduction
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorRocco Bilancia
About this trial
Surgical division of fissure is hypothesized to be safe and feasible. However, there is no preparatory study to test this hypothesis. It is logically expected that morbidity from the procedure could be less than standard LVRS and in preparation to a side-to-side trial of fissure division versus standard LVRS, a safety and feasibility study is required to test this hypothesis and inform future trial design.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age < or equal 75 years
Stable COPD with less than or equal to 10mg prednisolone daily
Nonsmoking for 3 months prior to screening and willing to not smoke during the study duration
Willing and able to complete protocol required study follow-up assessments and procedures
Disqualifiers
Fissure completeness <90% on pre EBLVR StratX (i.e less than 10% of fissure to be divided)
Chartis positive for collateral ventilation or not performed/not satisfactory at initial EBLVR
Quantitative perfusion of target lobe >25% of total on SPECT assessment.
Previous lung surgery or pleurodesis on the target side for LVR.
Trial design
Design model
Single group
Treatments tested in this trial
Surgical Lung Fissure Division
Procedure/SurgeryThoracoscopic surgical division of interlobar fissure, in patients who did not achieve Lung Volume Reduction following Endobronchial Valve insertion. Standard thoracoscopic approach under general anaesthetic, as per individual surgeon preference or practice. Fissure identified and surgical division with mechanical stapler performed.
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: Surgical Fissure DivisionOther 1 intervention
Trial outcomes
Primary outcomes
1
Number of patients recruited
At least 15 patients recruited into the trial over 18 months
Time frame
18 months2
Number of patients where surgical division of inter-lobar fissure can be successfully completed
Division of inter-lobar fissure can be completed in 90% of the patients enrolled
Time frame
Through study completion (18 months)3
Number of patients who experience serious adverse events as a result of the intervention
Number of patients who experience serious adverse events as a result of the intervention
Time frame
Through study completion (18 months)Secondary outcomes
1
Target lobar collapse
The number of patients achieving target lobar collapse
Time frame
Through study completion (18 months)2
Costs
The cumulative cost (in GBP) of hospital resources utilised (intraoperative consumables, theatre time, hospital stay, readmission costs)
Time frame
Through study completion (18 months)Other outcomes
1
Number of patients screened
Number of patients screened
Time frame
Through study completion (18 months)2
Proportion of patients consenting to take part
Proportion calculated with number of patients consented over patients screened
Time frame
Through study completion (18 months)3
Number of patient with >90% data completed
Number of patiens with \>90% data completed
Time frame
Through study completion (18 months)4
Proportion of patients with complete follow up
Number of patients with complete follow up post procedure (i.e. who completed visit 5) over patients who underwent the index procedure
Time frame
Through study completion (18 months)Locations
Sponsors and contacts
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Rocco Bilancia
Lead sponsor
Golden Jubilee National Hospital
Sponsor institution
Source ClinicalTrials.gov
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