Clinical trial NCT04039126: Comparison of the Effectiveness of Povidone-Iodine Alone to Povidone-Iodine-Tetracycline Combination
Official title: Comparison of the Effectiveness of Povidone-Iodine Alone to Povidone-Iodine-Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Malignant Pleural Effusion
Keywords: MALIGNANT PLEURAL EFFUSSION
Lead sponsor: University College Hospital, Ibadan
Sponsor class: OTHER
Collaborators: name: West African College of Surgeons
First posted: 2019-07-31
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Title of study: Comparison of the Effectiveness of Povidone-Iodine alone to Povidone-Iodine--Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion.

Research design: Prospective Randomized Controlled Clinical Trial. Background: Malignant pleural effusion (MPE) is commonly encountered in clinical practice among patients with malignancy. In addition to its association with major morbidities, it also poses a high risk of recurrence following drainage. Chemical pleurodesis is often required to achieve pleural adhesion and obliteration of the pleural space to prevent such recurrence. Several agents are in common use for chemical pleurodesis with mixed effectiveness.

Detailed description: STRUCTURED SUMMARY Title of study: Comparison of the Effectiveness of Povidone-Iodine alone to Povidone-Iodine--Tetracycline Combination for Chemical Pleurodesis in Malignant Pleural Effusion.

Research design: Prospective Randomized Controlled Clinical Trial. Background: Malignant pleural effusion (MPE) is commonly encountered in clinical practice among patients with malignancy. In addition to its association with major morbidities, it also poses a high risk of recurrence following drainage. Chemical pleurodesis is often required to achieve pleural adhesion and obliteration of the pleural space to prevent such recurrence. Several agents are in common use for chemical pleurodesis with mixed effectiveness.

Methodology: 62 consenting but blinded patients with clinical features of MPE who are undergoing pleural drainage and have fulfilled the criteria for chemical pleurodesis will be grouped by block balanced randomization into two equal groups- A and B. All the patients in Group A (Test) will have pleurodesis done with a solution combining 1 gram of sterile Tetracycline powder with 20mls of 10% Povidone-iodinemixed with 10mls of 1% xylocaine (for local intrapleural anesthesia) and 30mls of sterile water for injection instilled through the chest tube into the pleural space, while allpatients in Group B (Active control) will have 20mls of 10% Povidone-iodine mixed with 10mls of 1% xylocaine and 30mls of sterile water for injection. Drainage and radiographic parameters will be collected prior to chest tube removal and during outpatient follow-up to assess the effectiveness of pleurodesis in each group.

Objectives: To determine if combining tetracycline with 10% Povidone-iodine increases its effectiveness in pleurodesis for MPE.

Principal Exposure:Chemical pleurodesis with 10% Povidone-Iodine or combination of 10% Povidone-iodine-Tetracycline (1 gram).

Outcome variables: The primary outcome variable is the success of the pleurodesis in controlling MPE at 1month and 3 months follow-up. Success of pleurodesis classified as been Complete pleurosesis or Failed pleurodesis. The secondary outcome variables are: post-procedure complications of pain, hypotension,fever and occurrence of empyema thoracis, duration of thoracostomy tube retention post-pleurodesis, need for repeat of the procedure Keywords: Malignant Pleural Effusion, Chemical Pleurodesis, 10% Povidone-iodine, Tetracycline, Effectiveness

Eligibility criteria: Inclusion Criteria:

* • All adult patients aged between18- 70 years presenting with pleural effusion in association with a malignant disease.

  * Patients with documented malignant pleural effusion ( i.e positive pleural fluid for malignant cells on pleural fluid cytology and/or positive pleural biopsy for malignant tissue).
  * Reaccumulation of an effusion after drainage or patients presenting with symptoms related to pleural fluid re-accumulation such as dyspnea, cough and chest pain.
  * Patient with full lung re-expansion after thoracostomy tube insertion and drainage of effusion.

Exclusion Criteria:

* • Patients with known hypersensitivity either to Povidone-iodine and/or Tetracycline

  * Failure to achieve full lung re-expansion following drainage of the effusion within 48hrs
  * Locoregional radiotherapy to the effusion side.
  * Loculated pleural effusion
  * Refusal to participate in the study

Primary outcomes:
measure: Success of pleurodesis
timeFrame: 1 AND 3 MONTH AFTER PLEURODESIS
Secondary outcomes:
measure: Adverse Effects from the chemical pleurodesis agent used
timeFrame: immediate post procedure( 30minutes and 1 hour)
Other outcomes:
Locations:
city: Ibadan
country: Nigeria
facility: University College Hospital,
state: Oyo
Study officials:
affiliation: institute for advanced medical research and training, UI, IBADAN
name: catherine Falade, Prof.
role: STUDY_CHAIR
References:
citation: Psallidas I, Kalomenidis I, Porcel JM, Robinson BW, Stathopoulos GT. Malignant pleural effusion: from bench to bedside. Eur Respir Rev. 2016 Jun;25(140):189-98. doi: 10.1183/16000617.0019-2016.
citation: Antony VB, Loddenkemper R, Astoul P, Boutin C, Goldstraw P, Hott J, Rodriguez Panadero F, Sahn SA. Management of malignant pleural effusions. Eur Respir J. 2001 Aug;18(2):402-19. doi: 10.1183/09031936.01.00225601. No abstract available.
citation: Chernow B, Sahn SA. Carcinomatous involvement of the pleura: an analysis of 96 patients. Am J Med. 1977 Nov;63(5):695-702. doi: 10.1016/0002-9343(77)90154-1. No abstract available.