Pleurodesis

Pleurodesis

Effect of Thoracoscopic Talc Poudrage vs Talc Slurry via Chest Tube on Pleurodesis Failure Rate Among Patients With Malignant Pleural Effusions: A Randomized Clinical Trial

https://pubmed.ncbi.nlm.nih.gov/31804680/

Clinical Trial 

Reference: Bhatnagar R, Piotrowska HEG, Laskawiec-Szkonter M, et al. Effect of Thoracoscopic Talc Poudrage vs Talc Slurry via Chest Tube on Pleurodesis Failure Rate Among Patients with Malignant Pleural Effusions a Randomized Clinical Trial. JAMA 2020; 323(1):60-69.

Background: Talc pleurodesis is commonly performed to treat recurrent, symptomatic MPE. There are currently several methods for delivery of talc into the pleural space. This study sought to determine whether talc poudrage during thoracoscopy is more effective than talc slurry delivered via chest tube in successfully inducing pleurodesis.

PICO:

Populations:

  • 330 patients enrolled from August 2012 through April 2018 (166 in talc poudrage group and 164 in talc slurry group)
  • Patients had a confirmed diagnosis of MPE and were able to tolerate a thoracoscopy procedure with local anesthesia

Intervention:

  • Talc poudrage group: 4g talc poudrage during thoracoscopy while under moderate sedation

Comparison:

  • Talc slurry group: Bedside chest tube insertion with local anesthesia followed by administration of 4g talc slurry

Outcome:

  • Primary outcome: No difference in pleurodesis failure rates up to 90 days after randomization (P=0.74)
  • Secondary outcomes: No statistically significant differences in any of the 24 secondary outcomes, including time to pleurodesis failure, number of nights spent in the hospital over 90 days, patient reported thoracic pain and dyspnea, health related quality of life and all cause mortality.

Take Home: Among patients with MPE, both talc poudrage via thoracoscopy and talc slurry via chest tube administration resulted in no significant difference in pleurodesis failure rate at 90 days in this study. Both methods appear to be acceptable options for treatment of recurrent MPE.


 Indwelling Pleural Catheter versus Pleurodesis for Malignant Pleural Effusions. A Systematic Review and Meta-Analysis

https://www.ncbi.nlm.nih.gov/pubmed/30272486

Clinical Trial 

Reference: Iyer NP, Reddy CB, Wahidi MM, et al. Indwelling Pleural Catheter versus Pleurodesis for Malignant Pleural Effusions. A Systematic Review and Meta-Analysis. Ann Am Thorac Soc. 2019;16(1):124-131.

Background: This systematic review and meta-analysis sought to compare the efficacy of an IPC versus chemical pleurodesis in the management of MPE.

PICO:

Populations:

  • Patients being evaluated for definitive management of a symptomatic MPE

Intervention:

  • IPC placement

Comparison:

  • Chemical pleurodesis

Outcome:

  • Dyspnea – pooled data did not show any significant difference in dyspnea between groups at rest or during exercise
  • Survival – pooled data did not show any difference in mortality between the two groups at 3 months and individually, no study noted a difference between treatment groups in short-term or long-term mortality
  • Hospital length of stay – fewer hospitalization days with IPC compared to pleurodesis
  • Treatment failure determined as the need for additional pleural interventions or other criteria – fewer repeat ipsilateral pleural procedures in the IPC group when compared to the pleurodesis group
  • Adverse events – increased risk of infection in IPC group when compared to pleurodesis group

Take Home: This review and meta-analysis found no difference in survival or dyspnea between the two groups. Total hospital length of stay and the need for repeat ipsilateral pleural procedures was determined to be lower for patients with an IPC, but these patients were at an increased risk of developing cellulitis.


 Outpatient Talc Administration by Indwelling Pleural Catheter for Malignant Effusion

https://pubmed.ncbi.nlm.nih.gov/29617585/

Clinical Trial 

Reference: Bhatnagar R, Keenan E, Morley A, et al. Outpatient Talc Administration by Indwelling Pleural Catheter for Malignant Effusion. N Engl J Med 2018; 378:1313-1322.

Background: There are several methods for inducing pleurodesis in patients with recurrent MPE. This study evaluated whether talc administration through an indwelling pleural catheter is more effective at inducing pleurodesis than the use of an indwelling pleural catheter alone.

PICO:

Populations:

  • 154 patients were randomized to talc pleurodesis via IPC vs. placebo via IPC over a 4-year period at 18 centers in the UK
  • The patients underwent IPC placement followed by regular drainage at home for 10 days
  • No evidence of trapped lung

Intervention:

  • 4g Talc slurry administration via IPC after lidocaine administration

Comparison:

  • Placebo (50mL 0.9% sodium chloride) administration via IPC after lidocaine administration

Outcome:

  • Primary outcome: Significant difference in successful pleurodesis at day 35 after randomization between the two groups with more patients undergoing talc slurry administration achieving pleurodesis when compared to those given placebo
  • Secondary outcomes: Patients who received talc reported better QOL scores than those who received placebo at all time points and also had better symptom scores at all assessment points during the trial. No significant differences in effusion size or complexity or hospital LOS between the two groups. There was also no significant difference in mortality or adverse events between the two groups.

Take Home: Outpatient administration of talc slurry via IPC is a viable option for the treatment of recurrent MPE in patients without trapped lung. This treatment regimen may result in higher rates of pleurodesis than IPC alone, without frequent significant adverse events.


 Effect of an Indwelling Pleural Catheter vs Talc Pleurodesis on Hospitalization Days in Patients With Malignant Pleural Effusion: The AMPLE Randomized Clinical Trial

https://pubmed.ncbi.nlm.nih.gov/29164255/

Clinical Trial 

Reference: Thomas R, Fysh E, Smith N, et al. Effect of an Indwelling Pleural Catheter vs. Talc Pleurodesis on Hospitalization Days in Patients with Malignant Pleural Effusion: The AMPLE Randomized Clinical Trial. JAMA 2017; 318(19):1903-1912.

Background: IPC and talc pleurodesis are commonly performed procedures in patients with recurrent MPE. Patients with MPE often have a poor prognosis and short lifespan, therefore reducing hospitalization days is important to maintain independence and increased QOL in these patients. This study evaluated whether IPCs are more effective than talc pleurodesis in reducing total hospitalization days in the remaining lifespan of patients with MPE.

PICO:

Populations:

  • 146 patients with symptomatic MPE were recruited from July 2012 through October 2014 from 9 centers in Australia, New Zealand, Singapore and Hong Kong
  • Patients were randomized 1:1 (74 patients with IPC and 72 patients with talc pleurodesis procedure)
  • Patients minimized by malignancy and trapped lung

Intervention:

  • IPC placement followed by symptom guided drainage regimen

Comparison:

  • Tube thoracostomy placement (12-18F) followed by talc slurry administration

Outcome:

  • Primary outcome: The IPC group spent significantly fewer total days in the hospital from trial intervention to death or up to the point of 12-month follow-up when compared to the talc pleurodesis group. These were primarily effusion-related days.
  • Secondary outcomes: Fewer patients in the IPC group required further ipsilateral invasive pleural drainages. There were no significant differences in improvements in breathlessness or QOL between the two groups. Adverse events occurred in both groups with only 1% in the IPC group vs. 4% in the pleurodesis group experiencing serious adverse events.

Take Home: Whereas both IPC and talc pleurodesis appear to be reasonable options for the treatment of a recurrent MPE, IPC placement results in fewer total hospitalization days and fewer invasive pleural drainages when compared to talc pleurodesis.


 Effect of Opioids vs NSAIDs and Larger vs Smaller Chest Tube Size on Pain Control and Pleurodesis Efficacy Among Patients With Malignant Pleural Effusion: The TIME1 Randomized Clinical Trial

https://pubmed.ncbi.nlm.nih.gov/26720026/

Clinical Trial 

Reference: Rahman N, Pepperell J, Rehal S, et al. Effect of Opioids vs NSAIDs and Larger vs. Smaller Chest Tube Size on Pain Control and Pleurodesis Efficacy Among Patients with Malignant Pleural Effusion: The TIME1 Randomized Clinical Trial. JAMA 2015; 314(24):2641-2653.

Background: This study evaluated the effect of chest tube size as well as analgesia (opiates vs. NSAIDs) on pain and clinical efficacy related to pleurodesis in patients with MPE. Prior to this study, NSAIDs were typically avoided for pain control in patients undergoing a pleurodesis procedure as they were thought to reduce pleurodesis efficacy.

PICO:

Populations:

  • 320 patients with MPE undergoing a pleurodesis procedure from 2007 through 2013 at 16 UK hospitals

Intervention:

  • Patients undergoing thoracoscopy (n=204) received a 24F chest tube and were randomized to receive NSAIDs vs. opiates

Comparison:

  • Patients not undergoing thoracoscopy (n=114) were randomized to 1 of 4 groups (24F chest tube with NSAIDs, 24F chest tube with opiates, 12F chest tube with NSAIDs, 12F chest tube with opiates)

Outcome:

  • Primary outcomes: Pain while chest tube was in place and pleurodesis efficacy at 3 months
  • Pain scores in the NSAID group were not significantly different than the opiate group, but these patients did require more rescue analgesia
  • Patients in the NSAID group achieved pleurodesis at a non-inferior rate when compared to patients in the opiate group at 3 months
  • Pain scores were lower in the 12F chest tube group when compared to the 24F chest tube group
  • Pleurodesis failure rates in the 12F chest tube group were higher when compared to the 24F chest tube group and failed to meet non-inferiority criteria

Take Home: This study showed NSAIDs may be safe to use for analgesia in patients undergoing pleurodesis procedures without affecting pleurodesis efficacy. Also, smaller chest tubes may be a reasonable option when compared to larger chest tubes, but this study failure to demonstrate non-inferiority.


 

 Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial

https://www.ncbi.nlm.nih.gov/pubmed/22610520

Clinical Trial 

Reference: Davies HE, Mishra EK, Kahan BC, et al. Effect of an indwelling pleural catheter vs chest tube and talc pleurodesis for relieving dyspnea in patients with malignant pleural effusion: the TIME2 randomized controlled trial. JAMA. 2012;307(22):2383-9.

Background: MPE is a common cause of dyspnea in patients with cancer. There are various treatment options for these patients. This study sought to determine whether IPCs are more effective than chest tubes with talc slurry pleurodesis in relieving dyspnea in patients with MPE.

PICO:

Populations:

  • Adult patients with a diagnosis of MPE (either histological proof or the presence of a recurrent large pleural effusion in the context of cancer outside of the pleural space) requiring pleurodesis
  • Excluded patients with: life expectancy less than 3 months, chylothorax, previous lobectomy or pneumonectomy on the side of the effusion, previous attempted pleurodesis, pleural infection, WBC <1000/microL, hypercapnic ventilator failure, pregnancy, lactating mothers, irreversible bleeding diathesis and irreversible visual impairment

Intervention:

  • IPC group: Patients underwent IPC placement as an outpatient with initial removal of a large volume of pleural fluid and continued home drainage upon discharge

Comparison:

  • Talc pleurodesis group: Patients were admitted for chest tube insertion followed by talc slurry pleurodesis procedure

Outcome:

  • Primary outcome: No significant difference between the two groups
  • Mean daily dyspnea over the first 42 days after enrollment as measured by a 100mm VAS
  • Secondary outcomes:
  • Proportion of patients achieving a clinically significant decrease in mean VAS over the first 42 days after procedure. No significant difference between the two groups.
  • Mean VAS dyspnea at various time points measured on a 100mm VAS. Significant difference between the two groups at 6 months with a more significant decrease in dyspnea in the IPC group.
  • Mean daily chest pain over the first 42 days after procedure. No significant difference between the two groups.
  • Mean VAS chest pain at various time points measured on a 100mm VAS. No significant difference between the two groups.
  • Nights spent in the hospital from initial procedure to discharge. Pleurodesis patients had longer hospital stay.
  • All cause mortality up to 1 year after procedure. No significant difference in 1-year mortality.
  • Self-reported quality of life. No significant difference between the two groups.
  • Frequency of serious and non-serious adverse events. No significant difference between the groups.

Take Home: Both IPC placement and talc slurry pleurodesis improve dyspnea in patients with MPE. This study found no significant difference in dyspnea during the first 42 days between the two groups. There was a difference in dyspnea at 6 months at which the IPC group experienced less dyspnea. Patients with IPC spent less days in the hospital when compared to the talc pleurodesis group, but were at increased risk of complications associated with the catheter. A thorough evaluation and discussion must take place with patients with a MPE when determining an optimal management plan.


Phase III intergroup study of talc poudrage vs talc slurry sclerosis for malignant pleural effusion

https://pubmed.ncbi.nlm.nih.gov/15764775/

Clinical Trial 

Reference: Dresler C, Olak J, Herndon JE, et al. Phase III Intergroup study of talc poudrage vs. talc slurry sclerosis for malignant pleural effusion. CHEST 2005; 127:909.

Background: This study was designed to demonstrate the efficacy, safety and appropriate mode of instillation of talc for pleurodesis in patients with MPE while comparing talc poudrage to talc slurry.

PICO:

Populations:

  • Included: 501 adult patients with a diagnosis of MPE requiring pleurodesis, ECOG 0-2 with life expectancy >2 months, must have ability to undergo anesthesia
  • Excluded patients with: pregnancy, previous intra-pleural therapy or radiation therapy encompassing the entire hemithorax, changes in systemic therapy within 2 weeks prior to randomization or subsequent to sclerosis, chylous or bilateral effusions requiring therapy

Intervention:

  • Thoracoscopy in the operating room with instillation of 4-5g talc poudrage (n=242)

Comparison:

  • Chest tube placement with instillation of 4-5g talc slurry at bedside (n=240)

Outcome:

  • Primary outcome: No difference between groups in radiographic evidence of recurrent MPE at 30 days
  • Patients with primary lung or primary breast had higher success with thoracoscopic talc insufflation when compared to chest tube with talc slurry
  • Secondary outcomes:
  • Thoracoscopic talc insufflation was perceived to provide more patient comfort and less pain as well as more medical safety when compared to talc slurry
  • Patients receiving talc slurry pleurodesis experienced fewer respiratory complications when compared to those undergoing

Take Home: Both thoracoscopy with talc poudrage insufflation and tube thoracostomy with talc slurry administration seem to be effective at inducing pleurodesis in patients with MPE. When determining which specific procedure to perform, a thorough discussion should take place with the patient regarding the potential benefits and complications of each.