Prolonged Air Leak (PAL) Autologous Blood Patch Intervention Trial

Overview

About this study

The purpose of this study is to determine the safety and efficacy of autologous blood patch as a means to reduce the rate of prolonged air leak after lung cancer resection.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

-Patients who underwent elective wedge resection, segmentectomy, lobectomy, or bilobectomy for suspected non-small cell lung cancer

-Patients that have reviewed and signed the Informed Consent Form, had an opportunity to ask questions, and consent to have their de-identified data included in the study

-Patients who have an air leak on the morning of postoperative Day 3

-Age ≥ 18 years old

Exclusion Criteria: 

-Patients who undergo pneumonectomy, sleeve lobectomy, chest wall or diaphragm resection, or bilateral procedures

-Age ≤ 18 years old

-Women who are pregnant

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 3/25/2024. Questions regarding updates should be directed to the study team contact.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Janani Reisenauer, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

  • The objective of this study was to create a simple preoperative tool to assess the risk of prolonged air leak (PAL) using The Society of Thoracic Surgeons General Thoracic Surgery Database (STS GTSD). Read More on PubMed
  • The study objective was to develop an aggregate risk score for predicting the occurrence of prolonged air leak after video-assisted thoracoscopic lobectomy from patients registered in the European Society of Thoracic Surgeons database. Read More on PubMed
  • Prolonged air leak increases costs and worsens outcomes after pulmonary resection. We aimed to develop a clinical prediction tool for prolonged air leak using pretreatment and intraoperative variables. Read More on PubMed
  • Despite several randomized trials and meta-analyses, the dilemma as to whether to apply suction after subtotal pulmonary resection has not been solved. The combination of a poorly understood pathophysiology of the air leak phenomenon and the inadequate quality of the published randomized trials is actually preventing thoracic surgeons from abandoning an empirical management of chest drains. Even digital systems do not seem to have made the difference so far. Based on the evidence of the literature, the authors propose a new air leak predictor score (ALPS) as a contributing step toward appropriateness in using intraoperative sealants, opting for an external suction and managing and chest tubes. Read More on PubMed
  • Predictive models of prolonged air leak have relied on information not always available preoperatively (eg, extent of resection, pleural adhesions). Our objective was to construct a model to identify patients at increased risk of prolonged air leak using preoperative factors exclusively. Read More on PubMed
  • The incidence of any kind of air leaks after lung resections is reportedly around 50% of patients. The majority of these leaks doesn't require any specific intervention and ceases within a few hours or days. The recent literature defines a prolonged air leak (PAL) as an air leak lasting beyond postoperative day 5. PAL is associated with a generally worse outcome with a more complicated postoperative course anxd prolonged hospital stay and increased costs. Some authors therefore consider any PAL as surgical complication. PAL is the most prevalent postoperative complication following lung resection and the most important determinant of postoperative length of hospital stay. A low predicted postoperative forced expiratory volume in 1 second (ppoFEV1) and upper lobe disease have been identified as significant risk factors involved in developing air leaks. Infectious conditions have also been reported to increase the risk of PAL. In contrast to the problem of PAL, there is only limited information from the literature regarding apical spaces after lung resection, probably because this common finding rarely leads to clinical consequences. This article addresses the pathogenesis of PAL and apical spaces, their prediction, prevention and treatment with a special focus on surgery for infectious conditions. Different predictive models to identify patients at higher risk for the development of PAL are provided. The discussion of surgical treatment options includes the use of pneumoperitoneum, blood patch, intrabronchial valves (IBV) and the flutter valve, and addresses the old question, whether or not to apply suction to chest tubes. The discussed prophylactic armentarium comprises of pleural tenting, prophylactic intraoperative pneumoperitoneum, sealing of the lung, buttressing of staple lines, capitonnage after resection of hydatid cysts, and plastic surgical options. Read More on PubMed
  • Prolonged alveolar air leak (PAAL) is a frequent occurrence after lobectomy or lesser resections. The resulting complications and their impact are not well understood. Our aims are to prospectively determine the incidence and severity of PAAL after pulmonary resection using the Thoracic Morbidity & Mortality classification system and to identify risk factors. Read More on PubMed
  • Prolonged air leak (PAL) is the most common complication after partial lung resection and the most important determinant of length of hospital stay for patients post-operatively. The aim of this study was to determine the risk factors involved in developing air leaks and the consequences of PAL. Read More on PubMed
  • Persistent air leak (PAL) poses a significant challenge to the thoracic surgeon. Of the numerous methods employed to manage this problem, autologous blood 'patch' pleurodesis (ABPP) remains one of the most controversial, seemingly due to a lack of robust data and consensus of opinion regarding its efficacy, technique of application and its role in clinical practice. Despite a lack of randomized control trials, the evidence to-date has shown ABPP to be an efficacious, cheap, simple, well tolerated and readily available treatment, with minimal side effects and broad range of applications, allowing for earlier chest drain removal, decreased complications and decreased hospital stay. A review is therefore required to assess the role for ABPP in contemporary clinical practice. Read More on PubMed
  • The objective of this study was to better characterize prolonged air leak (PAL), defined as an air leak longer than 7 days, and to develop and validate a predictive model of this complication after pulmonary resection. Read More on PubMed
  • The aggressive and heterogeneous nature of lung cancer has thwarted efforts to reduce mortality from this cancer through the use of screening. The advent of low-dose helical computed tomography (CT) altered the landscape of lung-cancer screening, with studies indicating that low-dose CT detects many tumors at early stages. The National Lung Screening Trial (NLST) was conducted to determine whether screening with low-dose CT could reduce mortality from lung cancer. Read More on PubMed
  • The high rate of prolonged air leak (PAL) after pulmonary resection has prompted interest in surgical adjuncts designed to prevent this complication. However, these adjuncts are costly and might not be beneficial if used routinely. Identification of patients at highest risk might allow for more effective use of these adjuncts. Therefore, we sought to develop a simple scoring system to predict PAL. Read More on PubMed
  • A best evidence topic in thoracic surgery was written according to a structured protocol. The question addressed whether blood pleurodesis is effective for cessation of persistent air leak (PAL). Altogether more than 43 papers were found using the reported search, of which 10 represented the best evidence to answer the clinical question. The authors, journal, date and country of publication, patient group studied, study type, relevant outcomes and results of these papers are tabulated. We conclude that autologous blood pleurodesis has superior outcomes when compared with conservative management for treatment of postoperative PAL. In addition, for PAL causing pneumothorax, blood pleurodesis [optimal volume 100 ml (from two studies)] should be considered in patients who are unsuitable for surgery, talc pleurodesis is ineffective or not viable (including cases complicated by acute respiratory distress syndrome) and a prompt resolution is required. Some 70-81% of patients treated for postoperative air leak resolved within 12 h and 95-100% within 48 h vs. a mean of 3-6.3 days (from two studies) with simple drainage. Resolution of pneumothorax with blood pleurodesis was also significantly shorter (P<0.01). Overall success rates (from all studies) were 92.7% (n=133) from patients having undergone pulmonary surgery (76.6% in one injection, n=111), and 91.7% (n=109) of patients with pneumothorax. Recurrence rates were between 0 and 29% compared with 35-41% for simple drainage, although one controlled study in which the recurrence rate was improved from 16% in controls to 0% in the blood pleurodesis group (at 12-48 months). Minor complication (empyema/fever/pleural effusion) rates varied between studies (0-18%), although they show reduced incidence in line with improving technique over time. A controlled study looking at acute respiratory distress syndrome complicated by pneumothorax showed a significant reduction in mortality (odds ratio 0.6), time to cessation of air leak (P<0.01), weaning time (P<0.01) and intensive treatment unit (ITU) stay (P<0.01) whilst another randomized control study showed significant reduction in hospital stay following pulmonary resection (P<0.001). Read More on PubMed
  • Prolonged air leak (PAL) remains a frequent complication after lung resection. Perioperative preventative strategies have been tested, but their efficacy is often difficult to interpret due to heterogeneous inclusion criteria. The objective of this study was to develop and validate a practical score to stratify the risk of PAL after lobectomy. Read More on PubMed
  • Persistent air leak (PAL; defined as air leak > 5 days) after major pulmonary resection is prevalent and associated with significant morbidity. This study examines an incompletely characterized treatment for the management of PAL, chemical pleurodesis. Read More on PubMed
  • Persistent air leak after pulmonary resection is a difficult complication for thoracic surgeons to manage. Read More on PubMed
  • Air leak is a well-known problem, often leading to great discomfort and prolonged hospitalization. Many methods have been proposed for the prevention or treatment of prolonged air leak, but none of them turned out to offer the perfect solution. The purpose of this study was to evaluate the results of blood pleurodesis in patients with persistent air leak. Read More on PubMed
  • The study compares the efficiency, side effects and complications of autologous blood pleurodesis with talcum powder and tetracycline. Read More on PubMed
  • The aim of this study was to assess the value of instilling autologous blood into the pleural cavity to seal prolonged air leaks after lobectomy. Read More on PubMed
  • Air leak after pulmonary resection is a common occurrence that is incompletely characterized. Our objectives were to determine prevalence of air leak and identify its risk factors, characterize its duration and discover its correlates, and evaluate its clinical importance. Read More on PubMed
  • Prolonged air leak (PAL) after pulmonary surgery is a frequent occurrence and is reported to cause increased length of stay (LOS) and hospital costs although the costs directly attributable to PAL have never been published. The present study aims to compare the prevalence of pulmonary complications (atelectasis, pneumonia and pleural empyema) in patients with or without PAL and to quantify economic costs directly incurred by PAL in a series of pulmonary lobectomies. Read More on PubMed
  • To predict risk factors of a prolonged air leak following pulmonary lobectomy. Read More on PubMed
  • To evaluate the efficacy and risks of autologous 'blood patch' pleurodesis in patients with persistent air leak after pulmonary resection. Read More on PubMed
  • The objective of this study was to identify the predictors of prolonged air leak (air leak longer than 7 days) in patients submitted to pulmonary lobectomy for lung cancer. Read More on PubMed
  • To assess the incidence and clinical implications of postoperative pulmonary complications (PPCs) after lung resection, and to identify possible associated risk factors. Read More on PubMed
  • Persistent air leak after operation on the lung is one of the most common problems encountered by thoracic surgeons. We present 6 patients who underwent pleurodesis with autologous blood for persistent air leak after operation. Read More on PubMed
  • In a prospective study series of 167 patients with tube thoracostomy for spontaneous pneumothorax in 1993-1996, 32 patients (age range 16-79 years, mean age 45.5 years) were treated with autologous blood-patch pleurodesis for persistent air leak. In 27 (84%) of cases the air leak ceased within 72 h after the pleurodesis. The duration of air leak was significantly shorter (p < 0.01) than in simple drainage. Empyema developed in three cases, and two patients with failed pleurodesis required open thoracotomy. Minor complications, mainly fever and pleural effusion, occurred in nine patients. Neither analgesia nor sedation was required during or after pleurodesis. There was no recurrence of pneumothorax during 12-48 months of observation, whereas simple drainage was followed by recurrence in 22 patients. Blood-patch pleurodesis is a simple, effective and painless method in pneumothorax, but carries an increased risk of intrathoracic infection. Read More on PubMed