DIVision of the Interlobar Fissure in Patients Who Do Not Respond to Endobronchial Lung Volume Reduction

NCT07682168 | Not Yet Recruiting

• 1 other identifier: 25/CARD/25
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Emphysema; Lung Volume Reduction Surgery

Outcome Measures

Primary Outcomes (3)

• Number of patients recruited

  At least 15 patients recruited into the trial over 18 months

  18 months

• 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

  Through study completion (18 months)

• 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

  Through study completion (18 months)

Secondary Outcomes (2)

• Target lobar collapse

  Through study completion (18 months)

• Costs

  Through study completion (18 months)

Other Outcomes (4)

• Number of patients screened

  Through study completion (18 months)

• Proportion of patients consenting to take part

  Through study completion (18 months)

• Number of patient with >90% data completed

  Through study completion (18 months)

Study Arms (1)

Surgical Fissure Division

OTHER

Surgical Lung Fissure Division in patients who had endobronchial valves for severe emphysema and did not achieve lung volume reduction

Procedure: Surgical Lung Fissure Division

Interventions

Surgical Lung Fissure Division PROCEDURE

Thoracoscopic 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.

Surgical Fissure Division

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Fit for thoracoscopy under general anaesthesia (surgical and anaesthetic assessment)
• Recent (\< 18 months) endobronchial lung volume reduction (EBLVR) and lack of response defined by:
• Persistent symptomatic dyspnoea (mMRC \>2) which in the patient's view is no better than baseline
• Absence of target lobar collapse with any residual aeration apparent on imaging
• Persistence of (6a) and (6b) following post procedure StratX CT analysis and revisional bronchoscopy.

You may not qualify if:

• 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.
• Clinically significant bronchiectasis -greater than 4 tablespoons mucus per day.
• More than 3 COPD exacerbation episodes in the last year.
• Evidence of hypercapnia (pCO2 \>7KPa) - ABG to be performed on admission for index procedure
• Clear evidence of pulmonary hypertension (systolic pulmonary arterial pressure \>45mmHg) or evidence or right ventricular dysfunction as determined by a recent echocardiogram (\<12mo)
• Left ventricular ejection fraction (LVEF) less than 40% as determined by a recent echocardiogram (\<12mo)
• Myocardial infarction within 6 months of screening.
• Unable to safely discontinue anticoagulants or platelet activity inhibitors for 7 days.

Sponsors & Collaborators

• Rocco Bilancia: lead

Related Publications (3)

• Magge A, Kent MS, Ospina-Delgado D, Swenson KE, Parikh MS, Zhang C, Gangadharan SP, Majid A. Robotic-assisted Fissure Completion for Lung Volume Reduction with Endobronchial Valves. Ann Am Thorac Soc. 2022 Dec;19(12):2087-2090. doi: 10.1513/AnnalsATS.202204-308CC. No abstract available.

  PMID: 36454166 BACKGROUND

• Shafiq M, Polhemus E, Perkins R, Forth V, Marshall MB. Bilateral Bronchoscopic Lung Volume Reduction After Surgical Fissure Completion. Chest. 2022 Aug;162(2):e73-e75. doi: 10.1016/j.chest.2022.02.005.

  PMID: 35940665 BACKGROUND

• Majid A, Kheir F, Alape D, Chee A, Parikh M, DeVore L, Agnew A, Gangadharan S. Combined Thoracoscopic Surgical Stapling and Endobronchial Valve Placement For Lung Volume Reduction With Incomplete Lobar Fissures: An Experimental Pilot Animal Study. J Bronchology Interv Pulmonol. 2020 Apr;27(2):128-134. doi: 10.1097/LBR.0000000000000617.

  PMID: 31436607 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Emphysema

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Rocco Bilancia, MD

CONTACT

0141 951 5660; rocco.bilancia@gjnh.scot.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Thoracic Surgeon

Study Record Dates

• First Submitted: June 11, 2026
• First Posted: July 2, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: July 2, 2026

Record last verified: 2026-06