Endobronchial Valves in Inoperable Patients With Haemoptysis

NCT02816229 | Unknown

• 1 other identifier: N10/11/386
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

Massive haemoptysis is a life-threatening condition which is commonly seen in patients who have previously had pulmonary tuberculosis. Various treatment options exist such as bronchial artery embolisation (BAE) or surgical resection of the affect lung region. However, BAE is not considered curative as there is often recurrence of haemoptysis. Furthermore, not all patients will be deemed suitable for surgical resection, leaving them with very few treatment options. A possible alternative intervention is the insertion of an endobronchial valve (EBV). It is speculated that blood will collect distal to the one way valve and a thrombus will be formed. There is currently no data describing the use of EBV for the treatment of massive haemoptysis. This RCT aims to explore the use and efficacy of EBV in the management of massive haemoptysis.

Conditions

Haemoptysis

Keywords

Haemoptysis; Aspergillus; Endobronchial valve; Interventional pulmonology; Tuberculosis

Outcome Measures

Primary Outcomes (1)

• Rate of termination of haemoptysis

  1 year

Secondary Outcomes (5)

• Time to recurrence of haemoptysis

  1 year

• Improvement in exercise performance

  1 year

• Improvement in lung function

  1 year

• Recurrence of infection/tuberculsis

  1 year

• EBV related complications

  1 year

Study Arms (2)

Insertion of endobronchial valve

EXPERIMENTAL

Patients in this group will have one or more EBV inserted into the relevant lung regions to manage the haemoptysis via flexible bronchoscopy.

Device: Insertion of endobronchial valve

Best care

NO INTERVENTION

Patients will receive best medical care.

Interventions

Insertion of endobronchial valve DEVICE

One or more endobronchial one- way valves will be inserted into the appropriate lung regions

Insertion of endobronchial valve

Eligibility Criteria

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

You may qualify if:

• ≥18 years of age
• Written informed consent
• Current or previously documented admission to hospital with large volume haemoptysis (\>200ml/24hour); or haemoptysis with haemodynamic compromise (SBP \< 100mmHg for 15 minutes) or requiring fluid resuscitation; haemoptysis requiring intubation or deemed life-threatening by attending clinicians.
• The cause of haemoptysis must be due to severe underlying lung destruction/ bronchiectasis, post-tuberculous lung damage or the presence of an aspergillomata.
• Primary bronchial artery embolisation not considered technically possible\* or failed (defined as ongoing haemoptysis of at least 100 ml per day for 7 days or more, cumulative blood loss of \> 200 ml / 24 hours, or any volume resulting in a systolic blood pressure \< 100 mmHg for 15 minutes or necessitating resuscitation with vasopressors during a period of 30 days after BAE) and repeat BAE not considered feasible\*
• Lung resection not possible because of poor cardiopulmonary reserves (as defined by the current ERS/ESTS clinical guidelines28, independently reviewed by a team of consisting of a thoracic surgeon, pulmonologist and anaesthesiologist who will need to in absolute agreement on inoperability and/or lack of cardiopulmonary reserve)

You may not qualify if:

• Haemodynamic instability (defined as SBP\< 90mmHg requiring ongoing fluid resuscitation or inotropic support)
• Patients necessitating mechanical ventilation because of respiratory failure or airway management
• Active tuberculosis
• High clinical suspicion of lung carcinoma
• Any other condition, which in the opinion of the investigators, places the subject at increased risk for bronchoscopy and EBV placement.

Sponsors & Collaborators

• University of Stellenbosch: lead

Related Publications (4)

• van den Heuvel MM, Els Z, Koegelenberg CF, Naidu KM, Bolliger CT, Diacon AH. Risk factors for recurrence of haemoptysis following bronchial artery embolisation for life-threatening haemoptysis. Int J Tuberc Lung Dis. 2007 Aug;11(8):909-14.

  PMID: 17705959 BACKGROUND

• Gross AM, Diacon AH, van den Heuvel MM, Janse van Rensburg J, Harris D, Bolliger CT. Management of life-threatening haemoptysis in an area of high tuberculosis incidence. Int J Tuberc Lung Dis. 2009 Jul;13(7):875-80.

  PMID: 19555538 BACKGROUND

• Freitag L, Tekolf E, Stamatis G, Montag M, Greschuchna D. Three years experience with a new balloon catheter for the management of haemoptysis. Eur Respir J. 1994 Nov;7(11):2033-7.

  PMID: 7875278 BACKGROUND

• Dutau H, Palot A, Haas A, Decamps I, Durieux O. Endobronchial embolization with a silicone spigot as a temporary treatment for massive hemoptysis: a new bronchoscopic approach of the disease. Respiration. 2006;73(6):830-2. doi: 10.1159/000092954. Epub 2006 Apr 21.

  PMID: 16636529 BACKGROUND

MeSH Terms

Conditions

Hemoptysis; Tuberculosis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Brian Allwood, MBChB, PhD

  University of Stellenbosch

  STUDY CHAIR

Central Study Contacts

Brian Allwood, MBChB, PhD

CONTACT

brianallwood@sun.ac.za

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: June 23, 2016
• First Posted: June 28, 2016
• Study Start: January 1, 2019
• Primary Completion: December 1, 2019
• Study Completion: March 1, 2020
• Last Updated: October 12, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share