PATCHVALVE: Endobronchial Valves Plus Blood Patch for Persistent Air Leaks

Official title

PATCHVALVE Trial: A Prospective Evaluation of Blood Patch and Endobronchial Valves for Persistent Air Leaks - Pilot Study

Overview

The goal of this study is to evaluate the real-world safety and effectiveness of combining endobronchial valve (IBV) placement with endobronchial blood patching (EBP) for the treatment of persistent air leaks (PALs) in adult patients undergoing bronchoscopy. PALs are a challenging condition often associated with prolonged hospital stays, increased morbidity, and delayed recovery. The main questions this study aims to answer are: * Does the combination of endobronchial valve placement and endobronchial blood patching accelerate resolution of persistent air leaks? * What are the procedural outcomes, complications, and hospital-related metrics (e.g., chest tube duration, length of stay, and readmission rates) associated with this technique? Participants will: * Undergo standard-of-care bronchoscopy with identification of air leak source. * Receive intrabronchial instillation of autologous blood and tranexamic acid (TXA) followed by balloon occlusion and endobronchial valve placement. * Be followed for resolution of air leak and post-procedure outcomes through standard inpatient monitoring and data collection.

Detailed description

This study will include a prospective cohort of adult patients with persistent air leaks (PALs) undergoing bronchoscopy. The intervention evaluated is a combination approach that includes endobronchial valve placement and instillation of autologous blood with tranexamic acid (TXA), followed by balloon occlusion (referred to as "PATCHVALVE" technique).

Patients will be enrolled and undergo standard imaging and procedural evaluations. For prospective participants, informed consent will be obtained prior to the procedure.

Procedural steps include:

* Identification of the leaking segment using imaging and air leak assessment. * Instillation of fresh autologous blood (up to 30 mL) followed by TXA (up to 10 mL) via a balloon catheter into the leaking airway segment. * Balloon occlusion for 3-5 minutes to promote clotting and adherence. * Deployment of endobronchial valves based on standard criteria. * Leak reassessment and iterative treatment if necessary.

This study will provide early evidence on the efficacy of this combined approach and help standardize care protocols for managing PALs non-surgically.

Interventions

• Device Endobronchial Blood Patch
  This component of the procedure involves sealing persistent air leak (PAL) defects using autologous blood delivered via a balloon catheter. After identifying the target segment, carefully noting the airway angle and distal carina, a sizing balloon is deployed and inflated to ensure a tight seal. Under anesthesia, 30 mL of fresh blood is prepared and infused into the target airway until either visible extravasation occurs or the full volume is delivered. Following this, up to 10 mL of tranexamic
• Device Spiration Valve System (SVS) Placement
  Once the blood patch component is complete and the balloon is deflated, a Spiration Valve System (SVS) is placed proximally in the airway. The valve acts as a one-way device that decompresses the targeted lung segment while stabilizing the clot created by the blood patch. This supports durable resolution of the air leak, particularly in cases where collateral ventilation might otherwise reduce the efficacy of valve therapy alone.

Primary outcome measures

• Incidence of Adverse Events Following Combined Blood Patch and Spiration Valve Application [Time frame: From enrollment to the end of the observational period at 12 months post-intervention as per standard procedure]
• Feasibility of Combined Endobronchial Blood Patch and Spiration Valve Procedure [Time frame: From enrollment to end of procedure.]

Secondary outcome measures (6)

• Change in Air Leak Severity Based on Cerfolio Classification [Time frame: From enrollment to end of observational period at 12 months post-intervention as per standard procedure]
• Time to Air Leak Resolution [Time frame: From enrollment to end of observational period at 12 months post-intervention as per standard procedure.]
• Change in Chest Tube Suction Requirement [Time frame: From enrollment to end of observational period at 12 months post-intervention as per standard procedure]
• Time to Chest Tube Removal [Time frame: From enrollment to end of observational period at 12 months post-intervention as per standard procedure]
• Subsequent Interventions Required Following Blood Patch and Valve Treatment [Time frame: From enrollment to end of observational period at 12 months post-intervention as per standard procedure]
• Incidence of Respiratory Infections Following Combined Blood Patch and Spiration Valve Application [Time frame: From enrollment to the end of the observational period at 12 months post-intervention.]

Eligibility criteria

{Inclusion Criteria}

• Adult (≥18 years) patients who have been diagnosed with persistent air leaks (PALs) due to conditions such as alveolar-pleural fistulas following pulmonary resections, traumatic injury, or underlying lung disease or other cause.
• PAL patients who are deemed non-candidates for surgical intervention or have declined surgery.

{Exclusion Criteria}

• Patients who have received other experimental or investigational treatments for PALs that could confound the results.
• Patients with contraindications to undergoing bronchoscopy, such as severe cardiovascular instability, or those who cannot tolerate the procedure due to other medical reasons.
• Bronchopleural fistula

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• Beth Isreal Deaconess Medical Center — Boston

Publications

• Durrance RJ, D'Souza KG, Obata R, Bradley EC, Perwaiz MK. Endobronchial blood-patch: A novel technique for a persistent pleural air leak. Respir Med Case Rep. 2022 May 28;38:101670. doi: 10.1016/j.rmcr.2022.101670. eCollection 2022. PMID 35656093
• Watanabe S, Watanabe T, Urayama H. Endobronchial occlusion method of bronchopleural fistula with metallic coils and glue. Thorac Cardiovasc Surg. 2003 Apr;51(2):106-8. doi: 10.1055/s-2003-38981. PMID 12730823
• Takaoka K, Inoue S, Ohira S. Central bronchopleural fistulas closed by bronchoscopic injection of absolute ethanol. Chest. 2002 Jul;122(1):374-8. doi: 10.1378/chest.122.1.374. PMID 12114386
• Lopez C, Facciolo F, Lequaglie C, Rendina EA, Saita S, Dell'Amore D, Sollitto F, Urciuoli G, Loizzi M, Cisternino ML, Granone P, Angelelli A, Cardillo G, Mucilli F, Di Rienzo G. Efficacy and safety of fibrin sealant patch in the treatment of air leakage in thoracic surgery. Minerva Chir. 2013 Dec;68(6):559-67. PMID 24193288
• Thistlethwaite PA, Luketich JD, Ferson PF, Keenan RJ, Jamieson SW. Ablation of persistent air leaks after thoracic procedures with fibrin sealant. Ann Thorac Surg. 1999 Feb;67(2):575-7. doi: 10.1016/s0003-4975(98)01292-2. PMID 10197706
• Majid A, Kheir F, Sierra-Ruiz M, Ghattas C, Parikh M, Channick C, Keyes C, Chee A, Fernandez-Bussy S, Gangadharan S, Folch E. Assessment of Fissure Integrity in Patients With Intrabronchial Valves for Treatment of Prolonged Air Leak. Ann Thorac Surg. 2019 Feb;107(2):407-411. doi: 10.1016/j.athoracsur.2018.08.046. Epub 2018 Oct 10. PMID 30315804
• Ding M, Gao YD, Zeng XT, Guo Y, Yang J. Endobronchial one-way valves for treatment of persistent air leaks: a systematic review. Respir Res. 2017 Nov 6;18(1):186. doi: 10.1186/s12931-017-0666-y. PMID 29110704
• Gillespie CT, Sterman DH, Cerfolio RJ, Nader D, Mulligan MS, Mularski RA, Musani AI, Kucharczuk JC, Gonzalez HX, Springmeyer SC. Endobronchial valve treatment for prolonged air leaks of the lung: a case series. Ann Thorac Surg. 2011 Jan;91(1):270-3. doi: 10.1016/j.athoracsur.2010.07.093. PMID 21172529

Identifiers

NCT: NCT07184528 · 2025P000315

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗