Comparison of 40% Glucose Solution and Autologous Blood Patch Pleurodesis for Postoperative Air Leak After Lung Resections

NCT06936969 | Recruiting DMC

• 1 other identifier: 765/24
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Prolonged or persistent air leak (PAL) is one of the most common complications in patients after surgery on the lung parenchyma. Air leaks typically originate from alveolar-pleural fistulas, which can result from surgical manipulation of the lung parenchyma or the bronchial stump after procedures such as lobectomy. Key risk factors for PAL include extensive lung resections such as lobectomy, presence of pleural adhesions, incomplete interlobar fissures, chronic obstructive pulmonary disease (COPD), asthma, emphysema, advanced age, and reduced preoperative lung function, particularly low preoperative FEV1 values. PAL necessitates extended pleural drainage, leading to significant patient discomfort, pain, and substantial limitations in early postoperative rehabilitation. In patients with pre-existing pulmonary conditions like bronchial asthma or COPD, PAL can markedly worsen clinical status, resulting in severe complications such as infections, pneumonia, pleural empyema, acute respiratory distress syndrome, and even mortality. In extreme cases, PAL may contraindicate chemotherapy, causing significant delays in adjuvant therapy post-surgery. Effective management of PAL can significantly enhance patient quality of life, facilitating a quicker return to normal activities and continuation of systemic treatment. Moreover, PAL is a leading cause of extended hospitalization, invariably increasing treatment costs. Therefore, the necessity for safe and effective treatment of PAL is justified not only medically but also economically. Current standards for PAL treatment encompass both surgical and non-surgical methods. The available literature describes various conservative treatments, among which pleurodesis is commonly employed. Non-surgical pleurodesis techniques include the intrapleural administration of the patient's autologous blood or chemical agents such as medical talc, povidone-iodine, or doxycycline. Intrapleural administration of autologous blood, known as autologous blood patch pleurodesis (ABPP), is widely utilized for the conservative treatment of PAL. This method involves injecting the patient's own blood into the pleural space through an existing chest tube, promoting clot formation and sealing of the air leak. Studies have demonstrated the safety and efficacy of ABPP, with success rates exceeding 80% in sealing air leaks within 48 hours and a low incidence of complications such as fever or empyema. Another method highlighted in limited scientific literature is the intrapleural administration of a 50% glucose solution. This technique has been primarily reported by authors from Asian countries, such as Japan and Korea, and is not widely adopted in Western centers. Available studies emphasize its effectiveness, with success rates exceeding 80%, and report a lack of complications in patients undergoing pleurodesis with concentrated glucose solutions. The aim of our study is to compare the effectiveness of a 40% glucose solution with the ABPP. The selection of a 40% glucose solution is due to the unavailability of a 50% glucose solution in the Polish pharmaceutical market. Potential benefits of effective PAL treatment include improved patient quality of life, reduced hospitalization duration, decreased risk of complications, and lower treatment costs. Prolonged hospitalization and treatment associated with PAL generate significant expenses for the healthcare system. Our study may contribute to significant improvements in treatment outcomes, patient quality of life, and the cost-effectiveness of thoracic surgical procedures. In the long term, this research may also influence the development of new treatment standards and clinical protocols.

Conditions

Prolonged Air Leak; Persistent Air Leak

Keywords

PAL; ABPP; Prolonged air leak; persistent air leak; lung cancer; anatomical lung resection

Outcome Measures

Primary Outcomes (1)

• Number of Days Until Resolution of Prolonged Air Leak (PAL)

  The primary endpoint is the resolution of postoperative air leak after a maximum of three administrations of autologous blood pleurodesis (ABPP) or a 40% glucose solution. Resolution is defined as an air leak rate of less than 20 mL/min for at least 8 hours, successful drain removal, no pneumothorax on a control X-ray taken 3 hours after drain removal, and the patient's discharge home.

  From date of randomization up to 90 days from the procedure

Secondary Outcomes (1)

• Incidence of complications, number of days of prolonged chest drainage and length of inhospital stay (in days).

  From the date of randomization until 90 days following the procedure.

Study Arms (2)

Control group: patients with PAL in whom pleurodesis was performed using autologous blood (ABPP).

ACTIVE COMPARATOR

After obtaining informed consent, the patient will lie supine in their room. 30 minutes before the procedure, the patient's capillary blood glucose level will be measured. The patient does not have to fast before the procedure. The nurse will be asked to collect 120 ml of peripheral venous blood from the patient. Then the doctor, assisted by the nurse, will first administer 20 ml of 1% Lignocaine through the pleural drain, and then after about 5-10 minutes, the patient's previously collected venous blood. At the moment of blood administration, the drainage system will be disconnected. Then, the drain will be "injected" with 20 ml of air to avoid clogging the drain. The patient will remain supine for two hours post-procedure, maintaining fasting status. After 30 minutes from the administration of the patient's own blood, the capillary blood glucose level will be measured again. After two hours, the patient, with nursing assistance, may resume normal activities.

Procedure: Autologous blood patch pleurodesis

Study group: Patients in whom pleurodesis was performed using a 40% glucose solution.

EXPERIMENTAL

After obtaining informed consent, the patient will lie supine in their room. Thirty minutes prior to the procedure, a capillary blood glucose measurement will be taken; fasting is unnecessary. Initially, 20 ml of 1% lignocaine will be administered via the pleural drain. After a 5-10 minute interval, 120 ml of a 40% glucose solution (Glucose 40 B. Braun 400 mg/ml for infusion, Ecoflac Plus) will be infused using two separate Luer Lock syringes to prevent cross-contamination. At the time of glucose administration, the drainage system will be temporarily disconnected. Subsequently, 20 ml of air will be introduced into the drain to prevent occlusion. The patient will remain supine and refrain from sitting or rotating for two hours post-procedure, maintaining fasting status. Capillary blood glucose will be re-assessed 30 minutes after glucose administration. After two hours, the patient, with nursing assistance, may resume normal activities.

Procedure: 40% glucose solution pleurodesis

Interventions

Autologous blood patch pleurodesis PROCEDURE

The intervention in this study is distinguished by the fact that patients are randomized, the dose of both glucose and ABPP is 120 ml, the patient remains in a supine position for 2 hours after administration, the procedure can be repeated at 48-hour intervals, a maximum of 3 times.

Also known as: ABPP, bloodpatch

Control group: patients with PAL in whom pleurodesis was performed using autologous blood (ABPP).

40% glucose solution pleurodesis PROCEDURE

After obtaining informed consent, the patient will lie supine in their room. 30 minutes before the procedure, the patient's capillary blood glucose level will be measured. The patient does not have to fast before the procedure. The nurse will be asked to collect 120 ml of peripheral venous blood from the patient. Then the doctor, assisted by the nurse, will first administer 20 ml of 1% Lignocaine through the pleural drain, and then after about 5-10 minutes, the patient's previously collected venous blood. At the moment of blood administration, the drainage system will be disconnected. Then, the drain will be "injected" with 20 ml of air to avoid clogging the drain. The patient will remain supine for two hours post-procedure, maintaining fasting status. After 30 minutes from the administration of the patient's own blood, the capillary blood glucose level will be measured again. After two hours, the patient, with nursing assistance, may resume normal activities.

Also known as: chemical pleurodesis, glucose solution pleurodesis

Study group: Patients in whom pleurodesis was performed using a 40% glucose solution.

Eligibility Criteria

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

You may qualify if:

• Age: patients aged 18 years or older.
• Surgical Procedure: patients who underwent anatomical lung resections (segmentectomy, lobectomy, or bilobectomy) at the Department of Thoracic Surgery, Poznan University of Medical Sciences, between November 2023 and December 2024.
• Prolonged Air Leak Diagnosis: patients with diagnosed PAL after lung resection, as defined by air leakage persisting beyond 5 days post-surgery.
• Consent: patients who were willing to provide informed consent for participation in the study and for the intervention procedures (autologous blood pleurodesis or 40% glucose solution pleurodesis).

You may not qualify if:

• Non-Anatomical Resections: Patients who underwent non-anatomical resections, such as pneumonectomy, lung transplantation, sleeve resections, or wedge resections.
• Patients from whom the required volume of peripheral blood (120 ml) could not be collected.
• Active Infection or Sepsis: Patients with ongoing infections or sepsis at the time of enrollment.
• Reoperation or Additional Interventions: patients who required immediate reoperation or other interventions that disturb the process of treating PAL.
• Mental Health or Cognitive Impairment: patients with significant cognitive impairments or mental health conditions that hinder the ability to provide informed consent or comply with study procedures.
• Patients who failed to perform three ABPP or 40% glucose injections (no consent, need for urgent surgery).

Sponsors & Collaborators

• Wielkopolskie Centrum Pulmonologii i Torakochirurgii: lead
• Poznan University of Medical Sciences: collaborator

Study Sites (1)

Wielkopolskie Centrum Pulmonologii i Torakochirurgii

Poznan, Wielkopolska, 60-569, Poland

RECRUITING

Related Publications (1)

• Skrzypczak PJ, Dobiecki T, Rozmiarek M, Gabryel P, Kasprzyk M, Piwkowski C. Comparison of 40% Glucose Solution and Autologous Blood Patch Pleurodesis for the Treatment of Postoperative Air Leak After Lung Resections: A Prospective Randomized Controlled Study. Eur J Cardiothorac Surg. 2025 Nov 2;67(11):ezaf382. doi: 10.1093/ejcts/ezaf382.

  PMID: 41191623 DERIVED

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Piotr Jerzy Skrzypczak, MD

CONTACT

+48661962498; piotr.j.skrzypczak@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2025
• First Posted: April 20, 2025
• Study Start: December 22, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)